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Understanding how drugs work in “outside-the-lab” settings is crucial for life sciences brands. Even though randomized controlled trials (RCTs) remain the gold standard, they often show how a drug works in a perfect world where patients have only one condition and follow treatment plans to the letter.
As things are messier in real life, many companies turn to real-world evidence (RWE) to learn how their drugs perform across diverse patient groups and whether people stay on them or switch to something else.
This data is a goldmine not only for improving research and development but also for shaping how drugs are marketed. But before the Viseven team digs into that, let’s define real-world evidence (RWE) and look at a few examples.
Join the conversation and see how leading pharma brands are turning real-world data into real marketing results.
Real-world evidence (RWE) is the data gathered outside traditional clinical trials. It shines light on how treatments work in everyday life rather than under “polished” study conditions. There are several key sources of RWE:
Pharma companies usually collect RWE with a specific research purpose in mind. For example, brands may want to double-check whether their drugs are safe to use after they have been approved or expand applications. Another possible goal is to ensure the treatment truly benefits patients, so no one ends up paying for care with little to no real-world impact.
It’s also common to collect real-world data (RWD) opportunistically. Just like Amazon gathers tons of customer data and later figures out how to use it, pharmaceutical companies may collect real-world data first and then explore how a drug performs in a specific population. Yet, this approach often requires a massive effort to clean and organize the data. Plus, all these data manipulations can raise doubts about how reliable the final output is.
Pharma companies need RWE to effectively target and promote their offerings. Here are some key benefits:
RWE strengthens your marketing claims and builds confidence among HCPs. If the treatment proves effective not just in trials but in day-to-day practice, it becomes more compelling.
Research shows that 30% of providers prioritize information they can safely pass on to their patients. When HCPs can point to real-life results, it helps them build trust with patients as well.
Apart from HCPs and patients, marketing materials can also target payers and regulatory bodies. Using RWE can help persuade insurers to include a drug on reimbursement lists, improving market access. This is especially important for newer and costly treatments that many payers are not so willing to cover.
RWE can suggest specific patient groups that benefit most from a treatment. This allows marketers to segment audiences and create crisp, engaging, and persuasive messages. For example, if RWE shows that a drug is safe for pregnant women with hypothyroidism, brands can focus their efforts on this specific demographic, highlighting their needs, concerns, and priorities.
The evidence can also help predict which patients or HCPs are likely to switch brands or stop treatment and identify under-diagnosed populations. This makes it easier to understand the logic behind customers’ decisions and refine brand positioning accordingly.
Brands rely on RWE to quickly spot issues that could affect patient safety or clinical outcomes. If drugs are not performing as expected, they can proactively communicate with HCPs and patients. This kind of transparency helps maintain trust in the brand and shows that patient needs come before quick gains or saving face.
Leading pharmaceutical companies often see RWE as a chance to stand out in a crowded market. For example, social listening might reveal that HCPs prefer receiving digital content before meeting with medical reps. A brand that acts on this feedback can build a more customer-centric approach, sharing materials in advance and earning greater trust from this audience.
Understanding what drives trends or disruptions helps brands anticipate and steer them to their advantage. Here are the key factors fueling the use of RWE:
Currently, healthcare data makes up 30% of the world’s data. And its growth is not slowing down, especially with longitudinal data becoming more common. In some instances, we have years of a patient’s health information. By pulling together EHRs from different healthcare organizations, with patient demographics, pharmacy claims, and wearable device data, a much more complete picture of a patient’s health emerges.
Experts predict the RWE analytics market will see a 15% annual growth rate until 2029. According to a PwC report, this might be because RWE companies are competing to find the most advanced data analysis approaches to mine insights from research and development (R&D) and commercial phases.
Advice for pharma: To make better decisions, it is pivotal for brands to hire people with hands-on experience leveraging RWE. This does not necessarily mean data scientists only. It goes for top management and marketing teams, too. And if they are not looking to add in-house talent in specific areas, they can always use consulting services from RWE vendors.
RWE companies are seeing the value in focusing on specific treatment areas. It helps them compete more easily and better solve customers’ complex challenges. For example, by specializing in rare diseases, vendors can avoid crowded spaces but still have plenty of customers because there’s a strong need for new ways to treat these conditions. Specialization prompts companies to leverage data in new ways, running real-life trials, comparing therapies using external data, or improving study designs.
Advice for pharma: It is better to opt for RWE vendors that have a specific focus and handle a large portfolio, rather than stick with just a few that have not niched down.
Today, many regulatory bodies are on board with using RWE for multiple cases. For example, the Food and Drug Administration (FDA) allows brands to use RWE to ensure drugs’ safety or regulatory approvals. But even though regulations are pushing RWE forward, dealing with different data rules and laws in every country is still an uphill battle. This can make it challenging to launch and market a new drug globally.
Advice for pharma: As regulations are rapidly evolving, life science brands must make it a priority to ensure their data is high-quality and meets regulatory standards. This includes sourcing reliable data, cleaning and standardizing it, and keeping abreast of all compliance updates.
So, if you are thinking about using RWE, it is good to know what hurdles you might face. Here is a list of some key challenges:
To avoid serious legal and reputational risks, companies need to make patient privacy a top priority. Any data used for R&D or commercial activities needs to be anonymized. Plus, securing digital consents is a must, even though it can require significant time and staying power.
Accessing high-quality data is not enough. Companies should also consider its long-term governance and maintenance. Important questions to consider are: Who will be held accountable for this data’s lifecycle? Is there sufficient funding allocated for its ongoing support? And will our RWE practices remain viable as regulations evolve?
Data quality and completeness may substantially vary. Companies might get data with a lot of detail, but other sets could be missing insights, like patient outcomes. This makes it difficult to combine RWE and paint the full picture.
And to make things even more complicated, the data comes in all sorts of different formats, with different terms and structures. For example, a hospital might call a medical emergency a “heart attack,” but an insurance company might call it “MI.” This becomes a problem when life sciences companies are trying to combine data from different groups of patients to study diseases and clinical outcomes.
Pharma companies should leverage RWE cautiously due to potential biases. For instance, patients seeking treatment might differ from those who don’t, so their data may not accurately represent the whole population. Also, patients could exaggerate or inconsistently record symptoms in health diaries. Or the intentions of data recorders (patients, payers, HCPs) might affect evidence quality.
So, if you are feeling confident enough now to explore RWE for your commercial activities, you might find our implementation strategy viable and helpful.
The first thing is to figure out your “why” by setting clear goals. Are you looking to use RWE to persuade payers to cover your new treatment? Do you want to understand your patients better and target them more effectively? Or maybe you need to share an issue with your product to ensure it is used correctly?
Next, you should think about how and when you will fit RWE into your process. Being as specific as you can will help you keep your team accountable and see how you are progressing.
Just setting up reliable data collection, finding the right data analytics tools, and building teams is only half of the battle. Many companies get all the systems in place but then have trouble getting everyone else on board to actually use and trust RWE.
To convert your plan into action, a good idea is to start with a project that will have a big impact (what some people call a “lighthouse” use case) that answers an important business question. It is key that this case shows the approaches, processes, and methods that can be reused in future marketing. This way, you can show how valuable RWE is and get people from different parts of the company involved.
To ensure smooth cooperation, you may need to create a dedicated role within the global team to connect the RWE team, marketing, and R&D. This person will uncover new ways to use RWE, develop pipeline cases, and galvanize the organization to take advantage of its potential. This role involves keeping many balls in the air, combining industry knowledge, an entrepreneurial mindset, communication skills, and medical expertise.
When brands switch to RWE use, they tend to recruit many data scientists. But to scale successfully, you need to treat data as an asset (clean, standardized, and ready-to-use). This means also having data engineering and machine learning experts on board.
Just as important is having someone who can bridge the gap between tech and business. This team member can transform business needs into tech requirements and explain technical progress in a way that the business side can act upon.
The major goal is to make sure RWE is not perceived as a bolt-on or an additional step after a RCT but a vital gear in a well-oiled machine of evidence generation. Basically, it must cover all products, lifecycle stages, departments, and regions.
Your teams will also need to go beyond conventional data analytics and adopt more advanced approaches. While understanding past issues is important, predicting future trends is even more crucial. Pharma companies can, for instance, predict which patients will require their drugs and target them more effectively, which HCPs are likely early adopters, or which regions have a greater need for their intervention.
Patients do not live in isolated, sanitized settings. To truly understand a drug’s impact and patients’ reactions, you will need RWE alongside clinical trials. For pharma marketers, focusing on RWE is key to building solid customer relationships, avoiding communication missteps, and earning trust among HCPs and payers.
If you need help in integrating RWE in your commercial activities and marketing strategies, Viseven is here to help. We guide life sciences brands in building a clear strategy and roadmap, setting up operations to bring this vision to life, and building a future-proof tech ecosystem.
Let’s talk about how RWE can transform your next campaign—from insight to impact.
Real-world evidence (RWE) refers to health data collected outside of traditional randomized clinical trials (RCTs), such as from electronic health records, insurance claims, patient registries, or wearable devices. Unlike RCTs, which are controlled and idealized, RWE shows how treatments perform in routine care settings, across diverse patient populations and real-life conditions.
RWE in pharma helps brands validate marketing claims with real-life outcomes, increasing trust among healthcare professionals (HCPs), payers, and patients. It also supports targeted messaging, enhances market access discussions, and enables timely communication based on observed safety or performance trends in real-world use.
Many regulatory bodies, including the FDA, increasingly accept RWE to supplement clinical trial data for post-approval monitoring, label expansions, or even initial regulatory approvals. By providing insights into a drug’s safety and effectiveness in actual clinical settings, RWE strengthens the case for broader or continued use.
Some common challenges include data quality and standardization, patient privacy concerns, regulatory compliance across regions, and potential biases in how data is recorded or interpreted. Companies must invest in clean, well-governed datasets and ensure cross-functional collaboration between marketing, data, and medical teams to overcome these issues.
To start using RWE effectively, pharma brands should set clear commercial goals, establish a reliable data collection and analytics infrastructure, and create a high-impact “lighthouse” use case that demonstrates value. It’s also important to foster a culture that treats RWE as a core asset—not just an add-on to clinical trials.
