AI and MLR Review: Transforming Pharma Workflows

The medical, legal, and regulatory (MLR) review is undoubtedly one of the most important procedures in the pharmaceutical commercialization cycle. Yet, it is also one of the most complex and time-consuming as well. For many experts, especially in pharmaceutical marketing, MLR reviews often feel drawn out due to outdated methods and software.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 the Medical Legal Regulatory (MLR) Review Process?

MLR review, or medical, legal, and regulatory affairs review, is a crucial process in the healthcare industry that enables companies to ensure their content complies with current standards and laws, and can be published without posing any risks to patients and healthcare professionals.

How Companies Benefit From MLR Review Process in Pharma? 

Regulatory hurdles in the pharmaceutical industry rank among the top three biggest challenges. Even the smallest misstep can lead to 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 small business that creates and publishes any type of content faces a significant responsibility: providing both healthcare professionals and patients with accurate 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 also anywhere in the world.

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; an mistakes could result in huge fines. When an organization is found guilty of fraudulent marketing or misrepresenting its content and offerings, it may face fines amounting to millions of dollars, or even more. For example, one large company 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.

Key Stakeholders in Each MLR Stage 

There are three main teams responsible for thorough MLR reviews: medical, legal, and regulatory. Let’s review the responsibilities of each.

Medical 

These professionals are responsible for ensuring the medical and scientific accuracy of all content created. Whether it’s educational or promotional materials, or whether they are short or long, it’s crucial to go through the approval process with the medical team first, as they verify that the content is free from factual errors and contains accurate information.

Legal

The legal team consists of experts who verify that all information mentioned in the materials complies with current regulations and local laws. In other words, legal ensures that all marketing materials created won’t cause any legal issues or liabilities.

Regulatory

In highly regulated industries, regulatory review is a particularly important process, as it not only ensures that the content meets all applicable standards and stringent regulatory requirements but also eliminates any off-label claims. And while legal and regulatory teams may appear to be doing the same job at first glance, the key question for legal experts is “Could this expose us to legal action and misinterpretation?” and for regulators, it’s “Does this meet all regulatory and labeling requirements?”

Types of MLR Submissions

Many pharmaceutical and life sciences companies integrate MLR reviews incorrectly into their workflows. MLR reviews are often conducted when a serious paper is about to be published or a major conference is approaching, where everyone will 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. Below are some of the most common types of MLR submissions.

Promotional content

In most countries, companies may be fined for engaging in 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

Both patients and healthcare professionals might use this type of content. If there is a mistake in it, many people are likely to recall it and may even subconsciously apply 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

Although research is often published by scientists who are experts in their field, their publications should still be reviewed to identify 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 to ensure that no information mentioned in these documents could potentially harm someone’s health or safety. All communication within the firm has a direct impact on the work of new employees, affecting their interactions with patients and healthcare professionals.

How AI is Revolutionizing Pharma’s MLR Review

Meeting all compliance requirements when doing the work manually can take months. With the emergence of AI, approval timelines have shortened, and content creation takes much less time. Here is how AI is changing pharma’s MLR workflows:

Automating content review and approval 

Although it may take time to develop an AI-powered MLR tool that considers all regulatory and ethical standards, it can ultimately save significant money and resources in the future. Automated checks can enhance compliance rigor, streamline the approval process, and expedite MLR cycles.

Enhancing collaboration across teams 

Over 90% of employees surveyed reported that automation has improved their productivity, with 85% noting stronger collaboration across teams. Nearly nine in ten also said they trust automation to complete tasks accurately and support faster decision-making. AI can not just contribute to faster approvals, but also improve collaboration within teams by keeping everyone aligned and facilitating centralized feedback.

Reducing review time and human error 

On average, even simple tasks like writing an email or crafting a professional message can take around an hour. More complex tasks, such as creating a content plan or drafting product copy, may require a day or even more. When it comes to MLR review, it may take weeks to complete it manually. With AI, it is possible to shorten that time to days, and even hours. Artificial intelligence can scan content for potential errors, misspelled words, off-label statements, propose more effective phrasing, and compare content against approved materials.

MLR Review Process Challenges and Solutions

Ensuring pharmaceutical regulatory compliance is a challenging 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 refine the MLR review process, and what are the challenges associated with 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. Instead of spending money on new tools and an extra 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 heavily on a small number of experts who can handle reviews of marketing materials. As a result, two possible issues arise. First, when just a small team of people works 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 the knowledge accumulated over the years will be lost without a proper management system that allows not only for streamlining MLR processes but also for gathering insights from already conducted reviews. Ensure that you create a healthy environment for your employees and implement effective solutions to enhance MLR efficiency.

Lack of communication among reviewers

When MLR reviewers barely communicate with each other, this causes several issues, including transparency problems. To better understand why this is a significant issue, let’s consider a scenario. One of the reviewers reviewed a piece of content submitted by the 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 realizing it, resulting in a lost final version and delayed content delivery. Situations like this occur frequently, and to avoid them, reviewers should approach any task as a collective effort, focusing on communicating problems and ideas rather than working independently.

The time-consuming content review process

Content creation is a lengthy process in itself, often requiring a significant amount of resources and time to complete. 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 can cause significant stress, which is why some companies have begun to adopt a modular approach to content creation. 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 may not always see eye to eye. 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. Therefore, everyone should focus on distributing roles and responsibilities within the team 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 the pharma review committee to discuss what both sides can do to expedite content delivery.

Implementing AI in Your MLR Workflow

How can you integrate AI into your workflows without risking losing a lot of time and resources? Here are some important tips:

Evaluate your current AI-powered workflows

Considering that the “AI boom” began a few years ago, it’s likely that you have already implemented some AI capabilities into your processes. Before adding more on top of what you already have, first assess the existing workflows and how well they are integrated into your ecosystem, especially if any of these workflows are also part of the MLR review.

Ensure the human is in the loop

AI is an addition and not a replacement. Don’t rely on it too much to provide flawless results all the time; someone has to “fuel” it for it to deliver its outcomes consistently. Whether it is checking if marketing materials comply with all the standards or proofreading content for grammatical errors, human oversight is still necessary.

Plan a step-by-step integration

If there is very little AI present in your MLR review process, completely integrating it into all your workflows will only lead to more confusion and misalignment within the team. Start with small steps: introduce AI features one by one, allowing teams time to adjust to the changes, and provide educational materials to help them learn more about AI capabilities more quickly.

Future of MLR in the Pharmaceutical Industry 

As AI continues to change the pharmaceutical industry, it’s clear that MLR review processes will also evolve. Let’s take a look at how AI is expected to reshape MLR in the coming years:

Modular and pre-approved content libraries

Instead of reviewing every asset from scratch, future AI models will prioritize centralized reference repositories, structured content blocks, and DAM systems containing pre-approved materials and modular content.

Omnichannel & personalized governance

Currently, the capabilities of compliance software are primarily limited to reviewing static content. In the future, MLR will expand to approving more dynamic content, such as digital experiences, AI chatbot responses, and email journeys.

Integrated real-time review platforms

As MLR reviews evolve into broader, more comprehensive processes encompassing additional aspects of content production within the life sciences industry, future AI-powered MLR tools will become cloud-based, offering real-time redlining and compliance flagging, version control, audit trails, and seamless integration with DAM systems.

With platforms like eWizard, many companies will be able to accelerate the MLR process by at least 30%. As eWizard evolves, its users will gain access to even more features that make MLR reviews as fast and effortless as possible.

Final Remarks 

Healthcare marketing has always been challenging. Creating content that provides accurate medical information, complies with current regulations, and accurately represents the company’s vision is a significant challenge. However, with the right approach, it’s possible to consistently stay ahead of competitors while keeping up with all the trends and aligning with stakeholders.