Change Control in Pharma: Requirements and Process Posted on January 24, 2025February 4, 2025 by Vladyslav Kitsela Poor change control can pose serious risks for life sciences companies, including legal and financial jeopardy and, most importantly, threats to patient safety. For example, altering drug formulations without adequate testing could lead to dosage errors that put human lives at risk. Such incidents often result in reputation damage that companies then struggle to recover from. To prevent this, let’s explore the essentials of change control –– its requirements, process, and best practices. But first, let’s define what change control means in the pharmaceutical industry. What Is Change Control in Pharma? The change control process involves a set of practices designed to maintain product safety, compliance, and efficacy. This procedure lets companies ensure that all modifications are handled in a structured and efficient manner. Once reviewed, relevant stakeholders and the quality assurance team approve these changes. Even after implementation, there is still a long road ahead. The company must continuously monitor the change to ensure it does not compromise the product. Here are a few examples of changes in the pharma industry that require control: Why Do Pharma Companies Rely on Change Control? As mentioned, the change control procedures help maintain product quality and safety. But aside from that, why do pharma companies follow this process? Let’s explore the key reasons: Compliance: The change control process helps them meet local and international regulations, avoiding costly legal and financial issues. Efficiency: With proper change control in pharma, companies can reduce downtime and minimize disruptions during any updates or adjustments. Risk Assessment: It enables thorough planning for changes to address risks early without consuming too many resources. Transparency: With comprehensive records, pharma companies can easily justify every change when an inspection comes knocking. Key Change Types The change control process can be both proactive and reactive. Let’s examine them in more detail: Proactive A proactive change involves planning after a thorough assessment and approval process. These changes can be seen as opportunities for innovation and continuous improvement, whether it is enhancing existing products, technology, or processes. For example, it could be adopting a new manufacturing method or the latest software update. A planned change is all about a well-defined strategy. You might need to develop a business case, conduct a feasibility study, create a change management plan, and outline a project plan to bring it to life. It is crucial to view any change within the broader context of the company’s goals, values, and mission. Before implementation, key stakeholders should evaluate its impact on the organization as a whole, not just on product quality. Reactive A reactive change control process is an adjustment prompted by unexpected shifts in the external or internal environment. This often relates to changes in customer needs, market conditions, or regulatory updates. To stay afloat, companies must address factors beyond their control. Evolving expectations, adherence to new standards, and the integration challenges of acquisitions –– all of these require reactive change control for pharma companies. Change control management demands a flexible and agile approach. This may involve conducting a gap analysis, developing a change strategy, and evaluating its impact. Effective leadership and strong communication are key to navigating these adjustments and ensuring the process runs as smoothly as possible. What Are the Change Control Requirements? Change control process requirements vary between companies and regions, but here is a list of the most common ones to give you a general idea: EU 1252/2014 This is a guideline for companies operating in the European Union and dealing with active substances. It requires companies to evaluate how changes in the production process can impact the active substances. ICH Q10 This guideline states that if you are unsure that changes will result in the expected outcomes, there may be a problem that could compromise the product’s integrity. Quality risk management is crucial for evaluating the error likelihood. EudraLex Volume 4 GMP This is a key requirement for all European drug manufacturers. It establishes written procedures for managing any changes during production. For example, if you decide to upgrade to more innovative equipment, you will need to justify that the change keeps the quality top-notch. The requirement also emphasizes the use of quality risk management. This empowers brands to carefully plan these changes and account for all potential impacts on the product. FDA 21 CFR Part 211 This regulation governs the practices of U.S. life sciences companies. Below are the key aspects of its Good Manufacturing Practice (GMP) guidelines: 21 CFR 211.22: Any proposed change must receive final approval from the quality control unit. This unit must be equipped with all the necessary resources to conduct an effective evaluation. 21 CFR 211.100: Written procedures for production and process control are mandatory and must be approved by the quality control unit. Employees should fully understand how to manage changes. Any deviations from standard processes require clear justification and thorough documentation. 21 CFR 211.160: Comprehensive documentation is indispensable, especially in laboratory settings. What Is the Process for Change Control? The change control process flow heavily depends on the nature of the change and the type of your organization. In this section, we will discuss the basic steps you will need to take to manage adjustments to the product, system, or operations. Make a change request To start, submit a change request by completing the form and documenting the proposed adjustment. Clearly specify whether the change is planned or unplanned and categorize it as minor or major. Be sure to include the specific reasons for requesting the change. Review and assess Regulatory affairs, quality assurance, and manufacturing must ensure that your proposed change does not compromise product quality or safety and complies with current regulations. To do this, they assess the change’s impact to identify potential issues before implementation. Conduct risk assessment At this stage, the goal is to spot potential risks associated with the suggested change. It is essential to foresee any external and internal factors that might impact the product and organization. Review and approve The assigned employees review all data related to the change request, and then either approve or reject the proposal. Some changes may need approval from multiple stakeholders and require cross-functional team cooperation. Document the change Documentation allows companies to create a transparent workflow, maintain consistency in implementation, and ensure traceability, which is crucial for audits. It covers the details of the change, the rationale behind it, and the decisions made during review and approval. Conduct validation activities Depending on the nature of the change, you may need to perform validation activities. This presupposes studies and tests to ensure the change does not negatively affect product quality, quality, or safety. Notify regulatory bodies Some changes may require notifying regulatory authorities, such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA). This includes changes significant enough to affect regulatory filings and marketing authorizations for a product. Implement the change Implement your change according to the documentation created earlier. Organize tasks, assign team members, and establish clear deadlines for effective implementation. Sticking to a clear procedure will help you avoid a guess-and-check approach. Ensure that employees have the necessary resources to carry it out without major hiccups. Conduct employee training Once all approvals are in place, consider providing training if needed. The fear of change can be paralyzing for many employees, so make sure they have enough support to handle the stress. Monitor employees’ progress for greater effectiveness and accountability. Track performance This step ensures you are on the right track. Identify any deviations from the plan, document them, analyze potential reasons, and develop solutions to get back on course. Keep team members in the loop and encourage prompt assessments to maintain progress. Ensure closure Once the change is implemented, close the change control process. Make sure all approvals and documentation are complete and up to date. Best Practices for Smooth Change Control Follow these best practices to ensure a smooth change control processes without hitting rough patches: Leave room for dialogue Active listening and transparent communication are crucial for effective change control. Ongoing interaction with employees helps reduce their feelings of uncertainty, fear, and resistance while building trust and cooperation. Encourage your staff to share their concerns, contribute suggestions, and ask questions. Explain the why behind the change People change only when they choose to. Ensure those involved in implementing the change have the necessary context and understand the decision-making process. Explain how the change aligns with organizational goals and impacts their roles. Use a variety of communication methods, such as in-person meetings, emails, and more, to resonate with your team. Assign change control ambassadors Change control procedure champions are employees who orchestrate staff efforts and drive the change forward. They assign responsibilities, set deadlines, monitor progress, and evaluate effectiveness. Their involvement helps facilitate the process and fosters company-wide alignment in embracing the change. Request feedback across all levels Let employees’ voices ring. Encourage feedback from team members at all levels to uncover potential blockers and silent resistors. Assign a team member with strong emotional intelligence to collect feedback and share insights with key stakeholders. How Does Software Simplify Change Control Management? Change is the only constant in life and vital to any company’s growth. However, teams need support to embrace new working methods without feeling overwhelmed or anxious. Software solutions can simplify this transition and enhance team effectiveness. Here are a few possible ways technology can make a difference: It allows teams to plan change requests Most solutions let users document changes, covering impact assessments, risks, and budgets. Employees can see all tasks, responsibilities, and deadlines. Once a change request is approved, the software automatically notifies employees to remind them of their tasks. This enhances teamwork and fosters greater transparency and accountability. It analyzes the impact Before committing to a change process, it is essential to understand what’s needed to make it happen. Artificial intelligence (AI)-driven analytics enable stakeholders to visualize the impacts on timelines, budgets, business operations, and resources. This eliminates guesswork and helps make decisions grounded in real-world evidence. It foresees risks You should be prepared for worst-case scenarios to safeguard organizational health and product safety. Modern tools help users accurately anticipate these risks and create Plan B, Plan C, and so on. It regulates approvals Change control software guarantees that only the right stakeholders review and sign off on changes before implementation. Automated notifications keep everyone updated about their responsibilities, while detailed documentation of approvals strengthens accountability and builds transparency. Mastering Change Control with Ease In pharma, change control is a multi-step, regulated process that calls for strong cross-functional cooperation and dealing with bureaucratic tape. To maximize efforts and automate routine tasks, a robust software solution is essential. Viseven, a future-inspired tech company with over 15 years of experience in pharma technology, understands the industry’s unique challenges. We build solutions that address pharma stakeholders’ biggest pain points and needs. The numbers speak for themselves: 80% of our clients come from referrals. Need a robust change control solution? Drop us a line, and we’ll get back to you as quickly as possible.
Basic Guide to Process Validation in Pharma Posted on December 4, 2024February 4, 2025 by Vitalii Yaruta Back in the 1960s, pharmaceutical products have only been tested after production. If the final product met the standards, it would be cleared for patient use. This approach remained unchanged until the 1970s when a series of incidents shook the industry. One of the most tragic was the thalidomide disaster, in which pregnant women prescribed the drug to treat morning sickness suffered severe birth defects. This made drug developers realize that flaws in the manufacturing process could go unnoticed. By the late 1970s, the concept of process validation was introduced. How did the validation process change the industry and the lives of millions of people since then, and what does it look like now, in the age of advanced digital tech? This article will discuss pharmaceutical validation, its benefits, types, and basic recommendations. Keep on reading! Understanding Process Validation in the Pharma Industry History shows that just meeting final product standards is not enough. Gathering data throughout the production process is essential to ensure safe, high-quality pharmaceuticals. Pharmaceutical validation involves evaluating each manufacturing stage to ensure that predefined standards are consistently met. It also requires documenting the entire process, from raw material sourcing to product launch. Why Pharmaceutical Process Validation Is Important Let’s list the key benefits pharmaceutical process validation offers to drug developers: It ensures patient safety Pharmaceutical validation enables pharmaceutical companies to ensure drug safety. Errors in the manufacturing process can lead to defects in the drug, potentially putting patients’ health at risk. Assessments throughout the production lifecycle help guarantee that a drug is safe for consumption. It promotes consistent product quality Inconsistent product quality can have serious consequences for patients. Even small deviations in the production process can reduce product efficacy and compromise patient safety. By adhering to critical process parameters (CPPs), pharmaceutical companies can avoid legal and financial risks while building trust with patients in the safety and reliability of their products. It cuts down costs Cost reduction is a key commercial benefit for any business. Regular assessments of manufacturing stages not only ensure drug quality but also help reduce resource spending. By optimizing each process, pharmaceutical businesses can minimize waste throughout the production lifecycle. It ensures compliance The Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMA) strictly regulate the manufacturing process to ensure that end users receive effective therapies without health risks. Process validation helps companies maintain transparency with regulatory bodies and comply with current laws. It supports customer loyalty The key to winning loyal customers is delivering quality products consistently. Research shows that a staggering 73% of customers will abandon a brand after just one negative experience. This percentage is even higher in the pharmaceutical industry, where human life and health are on the line. Process validation helps companies continually meet quality standards, earning the trust of both healthcare providers (HCPs) and patients. Types of Process Validation There are four types of process validation: Prospective validation This type of process validation occurs during the development stage before product marketing to consumers. The primary objective is to ensure that the production design meets all necessary criteria. Concurrent Validation Concurrent validation involves gathering real-time data during actual production runs. This type of validation is particularly useful for fast product launches (think the COVID-19 vaccine) when there is no time for prospective validation. Retrospective Validation Unlike concurrent validation, retrospective validation relies on historical data from previous production runs. It is often used for well-established processes that consistently demonstrate strong performance over time. Revalidation Companies use revalidation when they significantly change raw materials, manufacturing processes, or equipment. The main goal is to ensure that these alterations have not impacted production and that everything continues functioning as expected. Key Steps of Process Validation There are three fundamental steps in process validation: Process design The goal of the process design stage is to find the right way to produce the product. Process controls ensure the drug’s safety and effectiveness by monitoring equipment and conducting tests. This is especially critical when intermediates are fully developed, and it is difficult to measure the drug’s properties. Process design should be based on solid evidence and include thorough documentation. Stakeholders need to record the studies that have helped improve their understanding of the manufacturing processes. Process qualification At this stage, the drug developer must confirm whether the process design works effectively for commercial use. It is essential to choose the right utility systems and equipment that meet the design standards. After that, the manufacturer has to make sure everything functions properly. Process performance qualification (PPQ) involves utilities, the facility, equipment, and trained staff. The FDA suggests using measurable data to monitor performance accurately. Teams also need clear protocols that cover data collection, production conditions, the sampling plan, and any necessary tests. The PPQ protocol should only be implemented after all major departments have signed off on it. Process verification Continued process verification aims to ensure the process stays approved during commercial production. For this reason, it is important to continuously collect and analyze data on drug quality to spot any changes or issues that need to be addressed. The FDA recommends ongoing sampling and performance tracking until enough data is gathered. It is also crucial for stakeholders to maintain the utilities, equipment, and facilities. Key Trends in Process Validation Tech disruptions have impacted every part of the pharmaceutical industry, and process validation is no exception. Here are some of the key trends we are seeing right now: Process analytical technologies As the name implies, process analytical technologies (PAT) use analytical tools to monitor, manage, and control drug production on the spot. Unlike the traditional approach that centers on controlling the quality of each batch, these technologies allow for dynamic management, helping to detect and correct errors on the spot. Let’s break down the key benefits so you understand whether this type of solution is right for you: Early error identification Tools like in-line sensors, chromatography, and spectroscopy empower life sciences teams to spot defects in real time. Comparing the instant data to pre-defined standards allows companies to quickly detect deviations, thereby reducing waste and improving drug manufacturing efficiency. Fact-based decision-making PAT provides a wealth of up-to-date data, allowing stakeholders to make strategic decisions instead of relying on blind guesses. This speeds up decision-making, enabling brands to catch quality issues early and launch products faster than their competitors. Automation PAT solutions can be merged with process control systems. When an error is detected, the system can automatically correct it. This level of automation helps keep the manufacturing process consistently error-free. Cloud-based quality management solutions Updating traditional quality management solutions is not easy. Pharma teams often worry about the added costs and potential production delays. On the other hand, avoiding updates makes it harder to stay afloat and competitive. Cloud solutions are becoming a popular trend for process validation, helping companies meet industry standards with less effort and expense. Its major gains include: Incremental updates Updates are handled gradually, causing minimal disruption, and there is often a rollback feature that allows users to undo changes with little downtime. No need for infrastructure Another advantage is that cloud quality management systems do not require additional infrastructure. This cuts costs and gives you greater freedom to scale at your own pace. Team of seasoned experts Many cloud providers offer validation experts who help life sciences brands improve their validation processes. Their goal is to reduce manual work so teams can narrow-focus their attention on core business operations. What Are the Challenges and Considerations to Check Out? As you have probably guessed, pharmaceutical validation is complex and full of roadblocks and potential pitfalls. Let’s take a closer look so we can be better prepared for them: Identifying key process parameters Quality teams must know which attributes to monitor to ensure the manufacturing process runs smoothly. That is why many organizations turn to data analytics to pinpoint the parameters that impact production the most. Cross-functional collaboration is often necessary. Companies can more easily identify the right attributes and parameters by bringing together teams from production, R&D, and quality assurance. Adapting to new technologies Given the pharmaceutical industry’s high-risk nature, it is no surprise that many companies are cautious about digitalization. Pharma brands often take their time adopting new solutions, especially in production processes. In this case, the best strategy is to eat a giant elephant with a teaspoon. It is important not to implement every solution under the sun across the entire validation process. Start small – test demo versions, set clear performance indicators, gather employee feedback, and evaluate the results before moving forward. Documenting all manufacturing stages Very few people enjoy the painstaking work of documenting a lengthy process in detail. It demands patience, attention to detail, and the readiness to make necessary edits along the way. Start by setting clear goals for organizing your documents and think about how you will store and manage records. You should decide what data to collect and how to categorize it. A solid data management system will help you avoid data silos, duplicate documents, and incorrect data tagging. It is worth noting that not backing up regularly is one of the biggest common mistakes. Setting up automatic backups can save your team from the nightmare of recreating documents from the ground up. Ensuring Smooth Validation in the Pharmaceutical Industry Process validation enables pharmaceutical companies to ensure that every step of the manufacturing process contributes to producing effective and safe drugs. Adhering to all regulations and standards is crucial for maintaining consistent product quality. Process validation has not escaped the wave of digitalization that has touched every part of the industry. Recently, real-time analytics and cloud solutions have gained popularity – and for good reason. They facilitate continuous quality control for each batch and keep the quality management tools up and running. If you are considering moving to the cloud, building a quality management system, or developing an analytical tool, the Viseven team has the expertise to meet your needs. Recently, we celebrated our 15th anniversary – 15 years of creating an average of 35 innovative healthcare solutions each year. More than 90 seasoned tech experts are behind these impressive numbers. Before you go, here is another statistic: 80% of our clients come from referrals. If you want to become one of our happy customers, Contact Us and let’s start a conversation.
Medical Legal Regulatory (MLR) Review Process in Pharma Posted on July 25, 2024February 4, 2025 by Andrii Nikulin The medical, legal, and regulatory (MLR) review is undoubtedly one of the most important procedures in the pharmaceutical industry. Yet, it is also one of the most complex and time-consuming as well. For many experts, especially in pharma marketing, MLR review often feels a bit drawn-out due to old methods and outdated software. Still, it remains a huge element of any content validation process. Learn all the basics of MLR reviews, their challenges, and their benefits in our guide. What is MLR Review? MLR review, or medical, legal, and regulatory affairs review, is an important process in the healthcare industry that helps companies ensure that all their content complies with current standards and laws and can be published without posing any risks to patients and healthcare professionals. The Role of MLR in the Pharma Industry Regulatory hurdles in pharma rank among the top three biggest challenges in the industry. Even the smallest misstep can lead to significant problems. This is why medical, legal, and regulatory (MLR) reviews exist: to help companies create digital content that won’t harm their patients’ health or the company’s reputation. Let’s take a look at a few more reasons why MLR is so important in the pharmaceutical and life sciences industries. Ensuring the accuracy and authenticity of all your content Every pharmaceutical or healthcare organization, company, or even small business that creates and publishes any type of content faces a huge responsibility: providing both healthcare professionals and patients with true information backed by facts, studies, and other evidence. Even the smallest mistake can put someone’s life in danger, which makes an optimized MLR review an important part of any content creation process. Promoting content worldwide When a pharmaceutical company publishes content, it often considers the norms and laws of the country in which it operates. But what if this company decides to expand worldwide? How can it ensure compliance with the laws it is not familiar with? This is where MLR reviews play a huge role. With the right MLR process, pharmaceutical companies can ensure compliance in medical marketing not only in their country of origin but anywhere in the world as well. Adhering to legal regulations Distributing inaccurate and misleading information can lead to serious repercussions. The pharmaceutical industry is very strict about complying with the laws; even the smallest mistake could result in huge fines. When an organization is found guilty of fraudulent marketing or misrepresenting its content and offerings, it could face fines amounting to millions of dollars, if not more. For example, Pfizer was fined $2.3 billion for the illegal marketing of four of its off-label drugs, which became one of the biggest fraud settlements in the healthcare industry. Maintaining a good brand reputation If your marketing content is inappropriate, filled with errors, contains misleading information, and includes made-up facts, it’s likely that sooner or later, it will make the news. This will put not only your patients but also your entire organization at risk. Your reputation will be severely damaged, and restoring it will be a huge challenge. At the very least, it will be a time-consuming and expensive process, potentially taking many years to settle. Types of MLR Submissions Many pharma and life sciences companies integrate MLR reviews into their workflows in the wrong way. MLR reviews are often conducted when there is a serious paper about to be published or a huge conference coming up where everyone would be listening to what the organization has to say. The truth is that MLR reviews are needed in 90% of cases, whether it is a website blog post or an important research paper. Here are some of the most common types of MLR submissions: Promotional content In many countries, companies might be fined for false advertising. Combined with pharmaceutical industry regulatory standards, it becomes crucial for every organization to ensure compliance in every promotional piece they create, even if it is a small tweet or Instagram post. Educational content This type of content might be used by both patients and healthcare professionals. If there is a mistake in it, many people are likely to remember it and might even subconsciously use this incorrect knowledge in the future. MLR review filters out false information, errors, and other types of mistakes from infiltrating educational content and influencing patients’ health. Scientific publications Even though research is always published by scientists who are experts in their field, their publications should still be reviewed to catch any potential oversights or errors. This includes verifying the evidence presented, the research results, and even the factual information. Compliance documentation Compliance documentation, such as pharma regulatory guidelines for audits and reviews, standard operating procedures, reports, and records, should also be verified by an MLR team. Just a small error could lead to many people adhering to compliance documentation and making the same mistake in their work. Internal communication All in-house communication, such as training documents, newsletters, surveys, and learning programs, often requires review if there is a possibility that any information mentioned in these documents might harm someone’s health or safety. All communication within the firm determines the work of people who are just starting to work there, directly impacting their interactions with patients and healthcare professionals. MLR Review Process Challenges & Their Solutions Ensuring pharmaceutical regulatory compliance is not an easy task. From creating a thriving environment for your MLR review team to meeting all possible deadlines, there are just too many details too important to forget. So, how can you polish the MLR review process, and what are the challenges behind it? Let’s discuss: Unfitting technology MLR reviews heavily depend on the software used to conduct them. If the chosen tools are not up-to-date, don’t consider all current laws and regulations, and simply don’t work well with all formats your organization works with, it’s likely that the final MLR review of your content will be incomplete and even incorrect. Instead of spending money on new tools and an additional workforce for additional reviewing, it’s best to invest in innovative software and tools that are regularly updated, fit your organization’s needs, and are easy to use for everyone who creates and submits content. High workload Speaking of the workforce, companies often rely too much on too few experts who can handle reviews of marketing materials. As a result, two possible issues arise. First, when just a small team of people work on the same important task all the time, it’s likely that at some point, most of them will feel overworked and even burned out. Moreover, when professionals responsible for MLR reviews eventually leave, they will also take all important knowledge with them, such as the location of any documents, specifics, and nuances inherent to an MLR review for a particular company, formatting requirements, the best content approval strategies specific to different types of documents, etc. All of the knowledge accumulated over the years will be gone without a proper management system that allows for not only streamlining MLR processes but also gathering insights from already conducted reviews. Ensure that you create a healthy environment for your employees and integrate proper solutions for MLR efficiency. Lack of communication among reviewers When MLR reviewers barely talk to each other, this causes a number of issues, including transparency problems. To better understand why this is a huge deal, let’s picture a situation. One of the reviewers looked at a piece of content submitted by a marketing team and left a few comments. After going through the document, another reviewer decided to message one of the authors regarding a few issues found in the text. The other reviewer is not aware of these issues and proceeds to contact the author to provide the same feedback, forcing a person to go through the identical process twice. In another scenario, some reviewers might create multiple versions of content without even knowing so, resulting in a lost final version and delayed content delivery. Situations like this happen all the time, and to avoid them, reviewers should treat any task as a collective effort and focus on communicating problems and ideas instead of just doing their jobs separately from others. The time-consuming content review process Content creation is a lengthy process itself, often requiring a lot of resources and time to be finished. And when, after all this time, content gets cut or, in the worst-case scenario, doesn’t even get approved, marketers feel like they have wasted all their time for nothing. For both MLR and marketing teams, situations like this cause a lot of stress, which is why some companies have started to adopt a modular approach to creating content. Instead of being a single unit, modular content can be broken down into different pieces or modules that work interchangeably. This way, marketers save time on content production, and MLR experts can focus on reviewing separate blocks of content. Difficulty coordinating promotional review committee (PRC) meetings Marketers and promotional review committees might not see eye to eye all the time. There is always a risk of a conflict in schedule, opinions, and priorities. For many companies, PRC meetings are quite rare, and when they do happen, there is a high chance that they will be inefficient. Remember that no matter how different everyone might be, they are still colleagues and share the same goals, so it’s best for everyone to focus on distributing roles and responsibilities within the teams and finding the most fitting solutions to the present challenges. For example, if there is a problem meeting deadlines, it might be a good idea for the marketing team and pharma review committee to discuss what both sides can do to speed up content delivery. Summing Up Healthcare marketing has always been challenging. Creating content that offers correct medical information, complies with current regulations, and properly represents the company’s vision is quite a conundrum. However, with the right approach, it’s possible to always stay ahead of the competitors while keeping up with all the trends and staying on the same page with stakeholders. If you would like to learn more about MLR approval in healthcare and how you can create content that will be 100% approved, contact us now. Our experts will provide you with a personalized consultation on the best solutions for pharmaceutical companies.
Healthcare Data Security: Protecting Patient’s Info Posted on June 26, 2024February 4, 2025 by Andrii Nikulin With the rapid digitization of medical records and increasing reliance on electronic systems, the importance of data security in healthcare cannot be overstated. Healthcare organizations are entrusted with vast amounts of highly sensitive information, including medical histories, diagnoses, treatment plans, and personal identifiable data. A single breach or data security issue in healthcare can have devastating consequences, jeopardizing individuals’ privacy and the integrity of clinical decision-making. One of the biggest threats to the security of healthcare data is the potential for unauthorized access by malicious actors or inadvertent mishandling of sensitive information. The latest data from the Office for Civil Rights shows 315 cyber attacks on the medical sector in 2024. Alarmingly, the most prevalent type of data breach has been hacking/IT incidents, highlighting the persistent threat posed by malicious actors exploiting vulnerabilities in healthcare organizations’ digital infrastructure. This underscores the urgent need for robust cybersecurity measures and proactive threat prevention strategies to safeguard patient data and mitigate the consequences of cyber attacks targeting the medical field. Let us figure out what data protection means for healthcare organizations and how you can achieve higher levels of security for sensitive data within the clinical environment. What is Healthcare Data Security? Healthcare data security refers to the measures and practices implemented to protect sensitive patient data, health information, and digital data within healthcare organizations. It encompasses a wide range of safeguards and security protocols aimed at preventing unauthorized access, data breaches, and security incidents that could compromise protected health information. Effective data security requires a comprehensive approach that addresses both technical and administrative aspects. This includes implementing robust data encryption techniques and role-based access control (RBAC) measures to ensure that only authorized users can access sensitive patient data. Additionally, it involves establishing rigorous policies, security management processes, and ongoing security awareness training for healthcare practitioners to cultivate a culture of data protection and privacy. The healthcare sector remains a prime target for cyber attacks, with malicious actors continuously seeking to exploit vulnerabilities and gain unauthorized access to valuable patient health information. Successful data security in healthcare requires a proactive approach to threat prevention, regular risk assessments, and the implementation of strong security measures to protect patient data and safeguard patient safety. By prioritizing data security for healthcare and implementing robust security protocols, healthcare organizations can not only protect sensitive patient information but also maintain data integrity, foster trust, and facilitate secure medical research and healthcare services. What are Related Challenges to Consider? Establishing adequate data security in healthcare is an uphill battle fraught with numerous challenges and risks. The sheer value of healthcare data, encompassing personal details, financial information, and comprehensive medical records, makes it an irresistible target for cybercriminals. This data can be exploited for identity theft, financial fraud, or sold on the dark web, making healthcare organizations high-value targets for sophisticated attacks and complex security breaches. Complexity of the healthcare ecosystem The complexity of the healthcare ecosystem, with its dense network of providers, insurers, and technology vendors, further amplifies vulnerability. Each participant in this interconnected web represents a potential entry point for cyberattacks, and the diverse nature of their systems and cybersecurity preparedness complicates the security landscape. As data flows across this ecosystem, the risk of exposure multiplies, necessitating stringent measures and collaborative cybersecurity strategies. Rapid adoption of digital technologies The rapid adoption of digital technologies, such as electronic health records, telemedicine platforms, and remote patient monitoring tools, expands the attack surface and creates new vulnerabilities. Legacy systems The prevalence of legacy systems in healthcare settings also makes them more susceptible to cyber attacks, as these outdated systems often lack regular security updates and patches to address emerging threats. This increased digital footprint demands robust cybersecurity measures to protect patient data and ensure service continuity. Regulatory compliance Compounding these challenges are stringent regulatory demands, with frameworks like HIPAA, GDPR, and HITECH Act setting baseline standards for data protection and severe penalties for non-compliance. Adhering to these regulations while safeguarding patient privacy and upholding service integrity and availability is a continuous endeavor for healthcare organizations that requires effective compliance management. Role of HIPAA and HITRUST Compliance for Healthcare Organizations HIPAA and HITRUST compliance is paramount for healthcare organizations to ensure robust data security and safeguard sensitive patient data. Here’s an overview of their significance in the context of data security in healthcare. HIPAA HIPAA (Health Insurance Portability and Accountability Act) serves as the cornerstone of healthcare data security in the United States. This federal law establishes the legal foundation for protecting sensitive healthcare data and electronic protected health information. Privacy and Security Rules – HIPAA’s Privacy Rule protects patient health information, while the Security Rule focuses on safeguarding electronic health records (EHRs) and other digital data. Breach notification – Requires healthcare organizations to report data breaches involving protected health information (PHI) to affected patients and relevant authorities. Access controls – Mandates that only authorized people can access sensitive patient information, promoting the principle of role-based access control. Data encryption – Encourages the use of data encryption to secure patient records and health information during storage and transmission. HITRUST HITRUST (Health Information Trust Alliance) plays a pivotal role in enhancing data security and ensuring robust data protection practices across the healthcare sector. At its core, HITRUST offers a comprehensive framework known as the Common Security Framework (CSF), which provides healthcare organizations with a standardized approach to managing security and privacy. This framework incorporates various healthcare regulations, offering a unified solution to address the complex landscape of data security in healthcare. Risk management – Helps healthcare institutions assess and mitigate data security issues in healthcare more effectively. Certification process – Offers a rigorous certification that demonstrates an organization’s commitment to healthcare data protection and information security. Threat prevention – Regularly updated to address evolving cyber attacks and security incidents in the healthcare sector. Third-party assurance – Provides assurance to patients, healthcare workers, and business associates about an organization’s data security practices. Top Healthcare Data Security Best Practices To significantly enhance your data protection efforts and reduce the risk of breaches and other security incidents, consider implementing these nine top healthcare data security best practices. Implement strong access controls: Utilize role-based access to make sure that only authorized users can access sensitive patient data. This includes multi-factor authentication and regular access audits. Develop and maintain security policies: Create clear, detailed security policies and procedures aligned with HIPAA Security Rule requirements. Ensure all healthcare workers are trained on these policies regularly. Encrypt sensitive data: Utilize robust data encryption for both data at rest and in transit. This applies to electronic health records, protected health information, and other sensitive medical data. Conduct regular risk assessments: Perform comprehensive security risk analyses to identify vulnerabilities in your health information technology systems and processes. This helps in proactively addressing potential data security issues in healthcare. Keep systems updated: Regularly update and patch all software, like operating systems, applications, and medical devices to protect against known vulnerabilities and cyber attacks. Train staff on security awareness: Conduct regular training sessions to educate healthcare workers about data security best practices, phishing threats, and the importance of protecting sensitive patient information. Have a robust incident response plan: Develop and regularly test a comprehensive plan for responding to data breaches or other security incidents in compliance with HIPAA breach notification requirements. Carefully manage third-party vendors: Healthcare companies frequently rely on third-party vendors for a variety of services. Ensure that all business associates and third-party vendors adhere to the same rigorous data security standards to maintain the integrity of your healthcare data protection efforts. For instance, our eWizard platform recently enhanced its security with penetration testing. Backup data securely: Regularly backup all critical health data and store backups securely, preferably off-site or in a secure cloud environment, to ensure data integrity and availability in case of a security incident. Healthcare Data Security Insights and Trends Healthcare data security is evolving rapidly in response to technological advancements and emerging threats. Let’s discuss. Switch to electronic records The transition to electronic health records (EHRs) has been a pivotal development in health information technology, dramatically improving the efficiency of patient care. However, this digital transformation has also expanded the attack surface for cybercriminals, making healthcare organizations high-value targets for data breaches. The widespread adoption of EHRs, which surged from 6.6% to 81.2% in the decade leading up to the COVID-19 pandemic, underscores the urgent need for enhanced data security measures to safeguard sensitive patient information. Rising threats Cybersecurity threats in healthcare continue to rise, with phishing attacks emerging as the most prevalent method for compromising data security. The increasing sophistication of these attacks, potentially leveraging artificial intelligence for more convincing phishing campaigns, poses a significant challenge to healthcare institutions. To combat these threats, organizations are turning to AI-powered security solutions for advanced threat detection and real-time incident response, helping to mitigate the risk of healthcare breaches. Unique nature of healthcare data The unique nature of healthcare data adds another layer of complexity to data security challenges. Healthcare organizations handle vast amounts of sensitive patient data, often stored across multiple systems and providers. This diverse and unstructured data, accounting for about 30% of the world’s data volume, creates interoperability issues and multiple points of vulnerability. To address these challenges, emerging technologies like blockchain are being explored to ensure data integrity and prevent unauthorized modifications to protected health information. IoMT security The rise of the Internet of Medical Things (IoMT) is another significant trend impacting healthcare data security. As more medical devices become connected, securing this expanding network becomes crucial for protecting patient safety and privacy. Healthcare organizations must implement robust security measures to safeguard these devices and the sensitive healthcare data they transmit and store. Cloud security As healthcare organizations increasingly migrate to cloud-based solutions, ensuring robust cloud security becomes paramount. Cloud security measures must be implemented to protect electronic protected health information and maintain HIPAA compliance in these distributed environments. Final Remarks The healthcare sector faces unprecedented challenges in data security, driven by technological advancements, evolving cyber threats, and regulatory changes. To address these challenges, healthcare organizations must adopt a multi-faceted approach to data security, leveraging emerging technologies like AI and blockchain, implementing strong access controls and encryption, and fostering a culture of security awareness among healthcare workers. Crucially, this commitment to data security must extend beyond the organization itself to encompass all vendors and collaborators in the healthcare ecosystem. It’s essential that every entity with access to sensitive healthcare data adheres to the same rigorous cybersecurity standards. At Viseven, we exemplify this commitment to healthcare data security. As an ISO-certified company, we regularly train our employees on the latest cybersecurity policies and best practices. Our solutions undergo rigorous testing to ensure they are robust and secure, providing our healthcare clients with the confidence that their sensitive patient data is protected to the highest standards. By staying on top of these trends, implementing comprehensive healthcare data security solutions, and partnering with security-conscious vendors like Viseven, healthcare organizations can better protect sensitive patient information, maintain regulatory compliance, and ensure the integrity and confidentiality of healthcare data in an increasingly digital landscape. This holistic approach to data security in healthcare not only safeguards patient privacy but also fosters trust and enables the safe adoption of innovative health information technologies that can improve patient care and outcomes.
Complete Guide on Pharmaceutical Medical Affairs Posted on November 17, 2022February 4, 2025 by Andrii Nikulin Medical affairs in Pharma are often seen as an essential department within a healthcare company that prioritizes communication among life science organizations, medical professionals, healthcare providers, and patients. Its primary function is communicating scientific and clinical information to the medical community through various channels. These medical affairs teams derive their value from high-profile medical expertise and provide efficient evidence of pharmaceutical products and medical devices. Team experts also impart details related to educational opportunities to the learners and improve their qualifications for eligibility to enter med affairs teams. Moreover, the educators of medical affairs instruct healthcare professionals through their scientific knowledge and clinical experience. What Are Pharmaceutical Medical Affairs? A medical affair is a pharmaceutical or medical company department that communicates the correct information about the drug or medical device to doctors, other medical practitioners and healthcare providers. For instance, medical affairs instruct the applications of a drug to potential healthcare companies after going through clinical cases. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug. The pharmaceutical medical affairs department officials include professionals with masters or doctorate degrees in pharmaceuticals. They instruct the applications of a drug to potential healthcare subscribers as soon as it is circulated in the market. They describe its use through a scientific and clinical approach by means of medical science liaisons. That is why the personnel working in medical affairs departments are known to be experts and leaders in the medical science field. They provide information about the following: Off-label usage Publications Safety information Independent medical education What Does a Medical Affairs Professional Do? Under its internal affairs, the pharmaceutical ones bring together the research and commercial wings of the pharma businesses. Medical affairs teams analyze and translate important details on therapeutics and drugs into an easy language for better understanding. Any healthcare experts and sales representatives can then grasp these details without a scientific background. There are also additional responsibilities of these teams, which include: Conducting non-registered clinical trials after the FDA approval of a drug. They also execute drug outcome studies and support healthcare brands. What Are Careers in Medical Affairs? There are many different medical affairs roles that require specific skills and qualifications. Here are some pharmaceutical affairs professionals that are currently in demand: Medical science liaison Medical science liaison, or MSL, is a specialist with wide-ranging roles and responsibilities. Their main task is to furnish medical or pharmaceutical companies with knowledge on the services, devices, or products of their employer. Medical science liaisons often attend events related to their field, consult with healthcare professionals, make sure that products and services are utilized in a correct way, and build relationships with stakeholders. In other words, medical science liaisons represent their company and provide knowledge on what their employer offers. Scientific advisor The job of a scientific advisor is to consult companies and professionals on treatment tools, drugs, and other topics. Often scientific advisors work closely with teams that are responsible for research and development and build strong relationships with the medical community. Medical affairs manager The responsibilities of a medical affairs manager include working with stakeholders, sharing their scientific knowledge, developing a medical affairs strategy, supervising different projects, and designing campaigns based on the company’s goals and vision. How to get into medical affairs? Every medical affairs company requires the candidates to have at least a master’s degree or higher. Experts who work in medical affairs must have enough knowledge and expertise to understand patients and doctors and assist companies in building a bridge between both sides. Moreover, it’s a common practice for companies to demand some level of experience in healthcare or related fields to ensure that candidates are well-versed in industry-specific knowledge. The Role of Medical Affairs in Pharmaceutical Companies The medical affairs department has many roles and responsibilities. It must bridge medical scientists and healthcare product manufacturers. The officials of medical affairs departments are increasingly playing the central role of creating coordination among the internal teams for attributes such as commercial, market access, regulatory, clinical development, implementation, and drug safety. These teams clearly convey their concerns about the company data and consistently educate on it. Besides these regular pharma medical affairs, its functions can also cover reorienting preclinical research. For this purpose, marketers create special medical affairs strategies. These strategies aim to facilitate trials that investigators initiate based on their predefined areas of interest. These strategies would enable the identification of new targets. It will also facilitate accessible developments in future clinical trials and increase knowledge about patients. In recent years, continuous regulatory norms have driven the importance of forming medical affairs teams. Many of the responsibilities on the regulatory team have been shifted to medical affairs. Many of the responsibilities include- Updating policies: Relevant drug and device-related information must be updated regularly to deliver valuable medical information. Framing training programs: The increased use of MSLs or regional medical liaisons to engage in scientific exchange with healthcare providers requires comprehensive policies and training of sales and marketing employees. Monitoring MSL employees: As the use of MSLs increases, the compliance issues surrounding these practices increase as well because MSLs must be assessed to ensure they remain compliant with the regulations affecting scientific communication. Planning the overall budget: Planning the overall budget to contain the development of new therapies and medical devices is another challenge, according to Medical Affairs Resources, Structures & Trends in primary research conducted by Best Practices. The researchers also explained that these advanced treatments are pressuring governments to allocate budgets accurately to new therapies and technologies budgeting. What Is the Function of Pharma Medical Affairs Today? What do affairs teams do in Pharma? Medical affairs experts represent pharmaceutical companies and facilitate them in maintaining the flow of information within the medical communities. During their interactions, these communities learn about a particular healthcare product’s market status. The following are the main functions of medical affairs in pharmaceutical industries: Conducting a rough clinical trial: They are responsible for additional clinical trials by non-registered medical affairs professionals. Analyzing health economics and outcomes: These officials conduct studies on healthcare economics and outcomes from a drug. This study is done to evaluate the results of using a medicine. The main idea behind the study is to estimate the medical cost of a drug and observe the quality of a patient’s life after using the drug. Assisting a brand in creating a healthcare product: Helping the brand team in formulating pharma medical strategy. Assessing clinical trial proposals: The officials review proposals for clinical trials that independent investigators prepare. Representing a publishing plan: Defining a publication plan for each product and coordinating clinical and scientific communication at medical conferences rests with the medical affairs team. Maintaining healthy relationships with top leaders: Pharma medical affairs professionals nurture relationships with key stakeholders such as healthcare practitioners and academic researchers. Organizing educational programs: Sponsoring healthcare practitioners’ education programs was in pharma medical affairs’ hands. They support the internal training programs. Reporting the latest news and insights related to pharmaceutical industries: The medical affairs team is almost like any other industry vertical PR team. They are abreast of the latest happenings within the industry, not just of their organization but of their competitors too. How Do Medical Affairs Impact the Pharmaceutical Industry? Today, medical affairs teams hold great significance within pharmaceutical businesses. They are marking their presence felt due to their collaborative characters. These teams are much more collaborative than working in isolation, allowing their expertise to have a wider impact within the medical fraternity. New medical affairs employment opportunities are also rising, indicating a revolution in pharmaceutical industries. For example, an increasing number of medical sales liaisons in the industry are shaping pharmaceutical companies perfectly enough to remain at the edge of the competition and highly advanced in the upcoming novel treatments. The medical affairs team’s contribution has a far-reaching impact on patient care. They are also helping to lead the pharma industry into a new age of scientific development and open collaboration. How Can Pharmaceuticals Improve Medical Communication Affairs? Improving medical communication is extremely important for a pharmaceutical company as it needs to translate complex science into layman’s language. Thus, medical information and communication professionals make use of data and insights and support medical affairs departments for: Leveraging communicative plans Managing the publication of new information Engaging with experts and thought leaders Providing medical education Facilitating internal communication Organizing and managing HCP events and advisory boards Many products and devices fail to reach the market because of safety concerns and improper communication. Therefore, it is vital to implement successful medical communication plans throughout the product lifecycle. These plans are necessary to include the right stakeholders. Ensuring the right stakeholders can lead to adequate scientific dialogue. Evolving New Ways of Medical Information and Communication Increased scope of activities & exposure Communicating medical information not only involves interacting with external stakeholders and maintaining up-to-date information on medical news. The report additionally includes- Reviews of a promotional interview Developments in in-field roles Creating product launch tool kits Framing education and training materials Setting up medical information booths Preparing conference presentations and posters Verification of content on product-specific and company-sponsored websites Publications Organizing clinical trial activities Digitalization of medical information Several digital channels other than emails and phone calls are emerging for effective communication. Examples of novel digital channels for healthcare systems are- Self-service portals Video-conferencing Social media platforms such as Twitter Online chatbots Voice search is also an emerging trend among different channels. These additional means of interaction are expected to expand medical and scientific information transformation with patients and related officers. Simplifying verbal communication amid heightened industry demands The rise of difficult-to-communicate therapies and personalized increased the need for improved communication. It has also become important for success in the pharmaceutical industry. As a result of these developments, companies are trying to manage contact centers and create accurate response documents effectively. Delivering meaningful insights to the industry A deep insight into medical information activities enables companies to shape the treatment journey of their patients. It also helps them to reduce the hurdles that come up in the way of getting marketing approvals. The companies will also be able to identify new patients for clinical trials and even engage with the right key opinion leaders by analyzing their inquiries, which is undeniable. Most importantly, they identify trending topics and provide opinions, insights, and metrics to measure content quality usage metrics to reveal the need to address safety, efficiency, or quality issues before the time ends. Also, they determine the highly impacted areas that focus on the potentiality of medical education, re-training, or product needs (e.g., formulation change). Conclusion Medical affairs in the pharmaceutical industry are frequently observed as supporters of companies. That is why responsibilities are increasingly being transferred from the regulatory departments of this department. Its responsibilities also encompass research in the medical field and communicating the data collected among concerned authorities. We live during times marking the paradigm shift from an environment dominated by commercial and marketing interests towards a new dimension in the advancing medical field. Medical knowledge and patients are being centrally focused along with successfully commercializing the prepared drugs. If you are looking for an expert communication channel for all medical and life science-related topics, get in touch with the experts at Viseven by filling contact form below.
Pharma Consent Management Based on Omnichannel Approach Posted on April 7, 2022February 4, 2025 by Andrii Nikulin Looking at the night sky, we might think about the horizons that technologies open for customer interaction and what lies ahead. Today the variety of channels available for customer interaction captures the imagination, however, without a sufficient amount of data, we can compare our audience to distant stars that we try to reach in the dark. Thus, the way organizations are collecting, managing, and utilizing users’ data in the era of digital omnichannel technologies has become a serious competitive advantage allowing them to provide something extra to the customers. How is it for pharma companies that have followed the path of digitalization but remain especially burdened in terms of different regulations? Let’s talk about how omnichannel technologies address these issues, introducing the secure basis for pharma communication in terms of regulatory compliance. What is the HCP consent management in pharma? Pharma’s regular operations are closely related to the procedure of consent collection. This is an obligatory practice as the data they possess is under the label ‘sensitive.’ Thus, at all times, the biggest possible threat to the pharma company’s reputation was the disclosure of confidential information. Under consent collection, we mean the generally accepted procedure when a physician or patient provides a legal basis for further communication with a particular pharmaceutical brand, providing their personal information like gender, age, location, email address, interests, etc. The marketers use this information to provide them with targeted ads and commit to processing and storing the obtained data properly, providing the correct operation of systems and tools that collect this data. This process is supported by General Data Protection Regulation or GDPR. This remarkable regulation obliges all brands you interact with to first ask consent before processing your data. Another urgent regulation is California Consumer Privacy Act, or CCPA that is aimed at protecting your right as a consumer enabling you to opt out of further communication and use of your data at any time. The consent policy may vary in complexity depending on the regulatory bodies of different countries. Usually, the compliance departments in pharma companies are responsible for ensuring that all the activities of the company are clearly regulated and comply with all laws, and regulations. However, despite that, pharmaceutical companies annually pay billions of dollars in fines for violations of rules or regulations. Consent can exist in several forms: Partial communication consent that allows communicating to HCP only via a channel where the consent was collected Holistic communication consent that allows communicating to HCP via all channels – emails, SMS, etc.) Consent to process personal data Consent for tracking a CLM activity for an account The rise of omnichannel communication has offered a wide range of opportunities for improved customer experience, however, at the same time, it comes along with many challenges of consent collection for numerous pharma companies. What’s wrong with pharma consent management? Making the transition from in-personal interaction to digital, we have inherited a huge amount of data that, if used correctly, allows us to deliver HCPs the ever-personalized content. We got an extra bunch of channels to deliver the right message to the HCPs, however, their newly acquired digital consuming habits have migrated from ordinary life to professional activities, and now they spend much of their working time balancing between devices. Now half of the HCPs said they want to receive promotional content on their mobile or tablet. Another 62% of HCPs and 57% of HCPs opt to get clinical and medical content on computers/laptops. This causes problems for pharma companies as it damages the environment in which they are accustomed to living. In the days when communication with a doctor was based mainly on personal communication, the process of gaining consent was strikingly different from what it is today. With the splash of digital activities, there was a need to manage huge amounts of data across multiple channels. For pharma, it has become a real challenge as there is still a huge gap in how to set up consent collection via digital channels. On the other hand, there is a tangled mess of regulatory measures in the industry that have no right to be violated. Are you aware of these problems? There is no centralized place for managing consents. The data is gathered through many different systems significantly complicating the tracking of the consent’s status. It’s hard to put together the customers’ data and align different types of activities. It all results in a time-consuming process requiring the intervention of many professionals. According to statistics, about 30% of data loss occur when connecting the data from one platform to the next. The other obstacle is the absence of valid customer data to start with or the availability of incorrect data that contains errors or typos in names or addresses. And the most common issue is when we simply have no idea what to introduce to the doctor and have a lack of content that would potentially interest the HCP. How the process of consent collection looks like? The consent collection process depends on the type of interaction, whether it is face-to-face or virtual interaction. As you may understand, it also depends on the Customer’s requirements, country legislation, and regulations. As, for example, certain countries require reps to send confirmation to HCPs for capturing consent. This can also be done via email. Other countries have regulations requiring HCPs to verify their email addresses when giving consent to receive email communications. In simply regulated countries, only 1 checkbox is required in the form to receive consent and communicate via all channels. In countries with more complicated regulations, 2 checkboxes are required. The difference in the number of channels that will be engaged in a communication. Usually, the subdivision is as follows: 1st checkbox – a consent to communicate via the current channel 2nd checkbox – a consent to communicate via other channels Also, the variety of tools that can be utilized for consent capturing. During the face-to-face meeting, consent is usually gathered with CLM (mobile part of the CRM). During virtual interaction, we can reinforce it with emails, landing pages, webinar registration, or filling out a form to download any materials which always results in better HCP engagement rate (43% of HCPs agree). In the end of the journey, customer data is transmitted to a customer’s CRM or consent management system. Prerequisites of Consent Collection Today, buyers are happy to provide their data in exchange for personalization to the brands they trust. However, in the pursuit of personalization, we should not forget about the importance of following all the rules of customer data management for HCPs. According to the GDPR, subscribers must have full control over the information they share and have easily searchable access to documents explaining the purposes for which their data will be used. The process of consent collecting should be transparent The main rule of CCPA must be observed that implies that before users consent to the processing of their data, they have the right to be informed that at any time they may refuse to communicate further. The right to be forgotten All materials and language you use to gather consent should be clear, understandable, and should not include vague, difficult-to-understand forms, wording, and terms. The process must be clear and eligible Earlier, in the article ‘Ensuring data security and compliance in pharma’s digital transformation’, we talked a lot about how to achieve security in personal data management and derived a golden rule for working with customer data, which read as follows: The customer should always be provided with transparency on what their data is used for, what channels will be engaged, and see what’s behind each tick they put into a checkbox. Omnichannel consent journey Earlier the routine communication of pharmaceutical companies with their target audience is based on personal communication. This was the case until the surge in digital activity and companies began to communicate with doctors through digital communication channels. This way of communication has settled in and turned out to be the preferred mode of communication to both parties. Pharma companies have reaped the benefits in terms of significantly higher engagement rates, while HCPs have found the optimal way to communicate with pharma brands without significant damage to their schedule. This can be traced in numbers saying that 50% of HCPs would like to engage digitally and remotely given their tight schedule. On the long road to obtaining a doctor’s consent, the biggest obstacle for a medical representative is primarily to get to this doctor, fit into the schedule and persuade them to give consent. Note that the last HCPs do without much enthusiasm. Thus, the most justifiable method is to collect consent through at least several channels. It turned out that the easiest way to get to the HCP is through their daily habits. The wide range of channels they use every day provides various opportunities to show up on their radar. It takes is qualitative content and an understanding of where to sell it. 61% of HCPs said they want pharma sales reps to have a better understanding of their needs and the needs of their patients. This is where the omnichannel stepped in and thrived introducing the new look at targeted digital HCP engagement. The ability to build a detailed customer journey allows to capture each interaction and consent in detail and provide the customer with the rights information through the right channel. For pharma companies, this means a large financial investment in terms of change management and the involvement of professionals who understand the specifics of the pharma industry and the process of collecting consents as well. A million-dollar issue? Not really since annual fines paid by pharmaceutical companies for non-compliance reach $9.6 million. How does it work? Becoming a trusted service provider takes compliance with certain communication rules, among them, are: The engaging content The trust and transparency The right time and channel The modern customer got used to the convenience of communication and independent choice of the appropriate format. The main idea is to communicate via social media, context, and target ads to the potential audience and provide some useful materials relating to their therapeutic area. Emails are the preferred channel for many HCPs. We can use them to introduce many types of content like webinar recording, presentation, and other useful materials. The engagement may also occur through landing pages, social media, posts, and many others. For example, pharma may develop a webinar involving KOL to expose the depth of the problem and build trust in the product showing its expertise. It would be a good piece of scientific content. To make it saleable on the market, it is crucial to present it to the right segment of HCPs through the channel they use. When in a certain country, we may have one checkbox, the flow is relatively simple. When there are two, the information in the customer’s account in the marketing automation system must be collected in separate fields. This, in turn, requires expert intervention, a specialist who can reconfigure these two fields in the automation system’s code, avoiding critical errors in the account. In some cases, companies reaping the benefits of the omnichannel approach may immediately define the target segment of HCPs and create the interactive content to satisfy their basic request a priori; conduct A/B testing, set the right targeting, and create the highly personalized social media marketing campaign. The advanced agencies on the market are distinguished by combining the technical and marketing expertise when it comes to omnichannel. This is especially graphical when it comes to consent. As a global provider of omnichannel services, Viseven implements Consent Collection and Management projects for global pharma companies considering their specifics and marketing goals. Fill out the form below to get a personal expertise and reap the benefits of digital communication in the most compliant manner.
Ensuring Data Protection and Pharma Compliance in Digital Transformation Posted on May 18, 2021February 4, 2025 by Andrii Nikulin Quicker than a storm, a pandemic has left us in a black hole of confusion and uncertainty. On this matter, pharma could be compared to a large ship that suddenly has lost its navigation in a stormy sea of changes that a new wave of digital has brought along. Various regulatory compliance pharma processes were paused, and many companies were looking for new solutions and ways to adjust to the new world. Since then, information security, pharmaceutical compliance standards, and consent management issues have become much more urgent and complex. Events like Next Normal Week exist to give us a landmark on how to navigate such turbulent times. We were excited to be a part of this event and share our expertise on how to secure pharma companies in terms of regulation and management of personal data thanks to the best DCF security standards – one of the hot-button topics of 2023. Read to discover the best practices and technical expertise that provide a robust, hyper-secure ecosystem “trained” to respect information security and pharma content compliance. What is Сompliance in Pharma? Regulatory compliance in the pharmaceutical industry refers to adherence and conformity to regulations, norms, and laws that apply to various processes in pharmaceutical companies, including marketing, operational, manufacturing, and others. The importance of regulatory compliance in the pharmaceutical industry cannot be overstated, since pharmaceutical products and services have a huge impact on public health. Navigating Data Security and Pharma Compliance Challenges Practically all areas of the pharma industry are entirely dependent on patient and HCP data and consent gathering. Pharma companies that are optimizing their content production workflows with organizations like Digital Content Factory in place often face increasing concerns regarding data security, access management, and compliance in the pharma industry. The rapid shift towards digital provides many opportunities for improved content management, but at the same time, it contains a lot of risk of information leakage – which has always been one of the biggest threats for pharmaceutical companies. It comes along with a snow globe of laws and regulations that only grows every year. When people are talking about gathering consent, the first thing they think about is compliance. It includes multiple areas: The General Data Protection Regulation (GDPR) The California Consumer Privacy Act (CCPA) and other regulations. The other important layer is Personal Data Management which includes gathering and storage of users’ consents, usage of systems that help us to get it (Web Forms, CRM systems, and others), Data Flow, Cyber Security, and Data Protection – the essential elements of pharma compliance, consent gathering and other pharmaceutical standards and compliance requirements. User experience (UX) is often overlooked but it is an important point for modern customers who are more than ever concerned with the security of their personal data. This process must be transparent enough, as according to statistics, 95% of customers say they are more likely to be loyal to a company they trust. At the level of UX it is important to provide opportunities for: Consent Gathering (Opt-in, Forms, Notifications); Terms of Use and Privacy Policy; Data Flow; Data Termination (Opt-out, Unsubscribe, Notifications); Right to be Forgotten. With the emergence of Artificial Intelligence, compliance in Pharma has started to change once more. Even though AI has opened a multitude of amazing opportunities, issues related to ethics, safety, and pharma data integrity compliance cannot be ignored. The compliance requirements for pharmaceutical companies are set to shift again, and organizations should initiate the groundwork for new beginnings right now. Even though the future of pharma regulatory compliance is still vague, we know for sure that there will be many new rules and laws that offer better protection of personal data and enhance market governance. The world of regulatory affairs is changing, and everyone is getting ready for what the future might hold for us. In such a highly regulated environment, pharma should apply all digital talents and pharmaceutical compliance management software to handle all processes in terms of data security and compliance management. Additionally, comprehensive training programs should be implemented to improve industry-based regulatory compliance across the organization. Why is Compliance Important in the Pharmaceutical Industry? Security of Medical Database So, how to establish an effective data compliance system? According to the IntSights report, about one-third of healthcare databases stored both locally and in the cloud are currently exposing sensitive patient data. Factors like misconfigured databases present one of the highest risks to security of patients and doctors’ data. The problem is that many healthcare providers have continued to shift data and other assets online without prioritizing investments in cybersecurity tools or procedures to prevent the leakage of sensitive information. Another possible threat is an expansion of the functionality without involving certified developers. In some cases, the limitations of the budget or the wrong choice of tech providers may lead to unacceptable practices, such as reverse engineering or unauthorized extensions, which make data vulnerable. So, it is strongly recommended to involve certified professionals whenever dealing with a licensed system. In terms of access, businesses are increasingly focused on measures like multi-factor authentication. Security-conscious companies may further limit the number of accesses to specific IP addresses and implement manual review or confirmation systems to minimize the risk of data leaks. Security of Content While the question of security and compliance issues in the pharmaceutical industry remains urgent, customers still expect coherent messaging and best-in-class content. The secure production of pharmaceutical content needs a specific protocol of the required measures and regulations. That’s why industry leaders are currently looking for a solution that can automate these processes. When pharma has an idea for a new project, they need an agency to turn it into reality. But it also comes with risks, as a lot of the data contained in the marketing and promotional materials are sensitive for the pharma companies. While meta-tagging greatly simplifies the search for the necessary information in digital asset management (DAM), a much better solution in terms of data security would be establishing access hierarchy. Under this system, each user is provided with a specific level of access to information. Also, to provide additional security when working with content, agencies can sign an NDA agreement and implement monitoring through a briefing tool. This approach improves the outcomes of pharmaceutical-agency partnerships. Even though a comprehensive brief is very important, it’s not always transmitted in a secure manner. It is much more convenient to use tools designed specifically for briefing, and that are built into the platform for working with content. The Brief Tool from eWizard is a valuable platform functionality used by Pharma & Life Science brand managers or marketers to provide comprehensive instructions to production partners. This tool outlines the vision for producing specific assets such as IVAs/eDetailers, Landing Pages, and Emails. It integrates pre-approved content modules and other branding elements, helps to define content structure and design expectations, ensuring the resulting production aligns with the brand’s objectives and guidelines. Consent Management Now, for the most part, the consent-gathering process is happening at the meetings with HCPs. This happens as follows: med rep asks an HCP if they are willing to receive updates from the pharma company. If the HCP is ready to share personal information – the consent-gathering process starts (see scheme 1). After that, all the data is going to the CRM or Marketing Automation system and the HCP starts getting bombarded by traffic from the pharma company. This is the model that is basically associated with the multi-channel approach. The problem is that it does not allow differentiation of the initial interest of the HCP and provides targeted communication where each message presents a real value for the customer. Scheme 1 Where the change of mindset should happen Where the change of mindset should happen Instead of getting a single tick from HCP that they are willing to receive further information on one channel, HCP is getting a full detailed list of the options you are offering as a service. From that moment on, the HCPs are getting targeted information that is based on their initial interest. For example, if the HCP ticks a face-to-face visit, the information goes straight to the CRM system or the Consent Management system, depending on the infrastructure that the company is using. Then, a sales rep can process this information and plan the eDetailer presentation and further activities accordingly. If the HCP chooses to receive a broadcast email, it brings the whole integration with a marketing automation system. HCPs can get various types of marketing information from marketers, contractors, and other people who are in charge of this process. This practically changes the name of the game and gives the customer a broad picture of what they are signing up for and what type of information they can expect from the pharma company in exchange for consent. However, the other cast-iron rule is that the customer, at any minute, has a right to unsubscribe from the information they previously agreed to receive. Another key aspect of changing the mindset in the consent management process is hat with this model, customers have the option to opt out of communication through one specific channel, such as broadcast emails (see scheme 2), while still receiving information through other channels like portals and events. By using this checkbox, the company may deactivate undesirable activities without interrupting an entire communication with the HCP. Scheme 2 This way, we can generate the golden rule of consent management: the customer should always be provided with transparency regarding the use of their data, communication channels used, and meaning behind each checkbox they choose. Which ISO is for the Pharmaceutical Industry? The International Standards Organization (ISO) means that the company has implemented a number of procedures, policies, and guidelines, allowing it to attain robust control and protection over the company’s assets. Thanks to ISO, we can guarantee complete pharma regulatory compliance. There are a few other certifications that pharmaceutical companies must have to continue operating safely and without causing any harm to their clients and patients. Here is a short list of those certifications: ISO 45001 This certification helps create a safe environment for employees and reduces various health and safety risks. ISO 9001 This standard specifies the requirements for Quality Management Systems. Before launching a new pharmaceutical product, it’s crucial to ensure that it complies with all applicable regulatory requirements to guarantee its safety and efficacy, and this is what this certification is responsible for. ISO 14001 With this certification, companies can improve their environmental performance and mitigate environmental harm. Pharma regulatory and compliance guidelines are constantly evolving, requiring many organizations to stay updated with the latest industry standards. Pharmaceutical companies manage a huge amount of sensitive information that cannot be disclosed. Today, the need to remain competitive and provide a secure environment for pharma customers prompts us to be certified against a strictly defined and delineated standard which is ISO/IEC 27001. Viseven has successfully passed the first supervisory audit ISO 27001. Among the main advantages of adhering to the completed pharmaceutical compliance certification norms and pharma compliance regulations are asset protection from leakage, theft, or loss; higher trust from the customers, as well as employees’ confidence. All of this ensures our greater strength in the highly competitive landscape, with clear and transparent workflows, as well as role distribution among our specialists. In case you have questions concerning our expertise in establishing a robust hyper-secure ecosystem – turn to our experts for insights and guidance.
