This is a co-authored blog post between Vodori and Marimac Insight, a scientific management consulting company.
Considering a new medical, legal, regulatory review software solution at your pharma or device company is a big undertaking. Involving key stakeholders in this process is essential for success and a smooth transition to the new system.
While marketing and regulatory teams often lead the promotional review process, it’s critical to include your medical affairs team in the system selection and MLR process design. Medical affairs teams need to have a system and process that enables them to ensure medical and scientific accuracy of materials, as well as safety and efficacy data. Therefore, their insights into what’s specifically needed from an MLR solution will be invaluable to selecting the system that is right for your company and how that process is carried out at your life science organization.
Let’s take a closer look at the three key reasons to include medical affairs in your MLR system selection and process design.
Create buy-in for a new system up-front
Medical affairs teams are often considered the “power users” of an MLR system because the medical literature and claims review process is often very labor intensive for the medical team. When in the early stages of selecting a new MLR tool, different users have different perspectives on the need and what is most important from the new solution. Engaging and securing early buy-in from your medical affairs team will lead to better system adoption, smoother day-to-day use, and greater awareness of system functionality.
To further create buy-in for an MLR tool, be sure to include medical affairs as part of the demo process. It will allow them to ask specific questions for their role, see how the system works, and will ensure that their needs are going to be met by the MLR systems being considered. In addition, consult medical affairs when developing timelines for implementing a new software solution to ensure it doesn’t overlap or interfere with any planned initiatives.
Understand medical affairs’ requirements
When you’re looking for a MLR solution and establishing your claims review processes, it’s important that all key stakeholders (with responsibility for your medical claims and compliance) have a seat at the table. Each department, including medical affairs, will have specific requirements that need to be met by the new MLR process you plan to implement. While the marketing team may prioritize certain features that help expedite the overall campaign process, medical affairs will often prioritize features that make it easy to navigate between the medical literature and promotional content they are reviewing, or reference past medical reviews that have been completed.
Discussing your ideal process will reveal key features, functionality, and compliance requirements that are essential for each stakeholder, like validation packages, and/or analytic & reporting capabilities.
Additionally, by including medical affairs, you can have specific conversations around workflow requirements. For many life sciences organizations, it is important to have separate workflows for ad/promo and medical information content and the medical team can help you understand this need. Medical affairs may also need unique features like strict permissioning that only allow certain individuals to review and access approved medical content.
Achieve MLR efficiency
By including medical affairs in the planning and decision-making phases, you’ll save time once your MLR system is up and running because everyone will be bought into your process and system. By playing a role in the decision-making process and ok’ing the solution, medical affairs will have a robust ownership and understanding of the system which in turn reduces onboarding time and improves overall system adoption.
Including medical affairs, as well as other key stakeholders, into your MLR system selection and process design ensures that everyone involved is on the same page. Having these discussions as a group will lead to higher user adoption, user satisfaction, and helps everyone feel ownership over the process or the part they play during MLR review.
About Marimac Insight
Marimac Insight is a scientific management consulting company focused on helping organizations in the life sciences develop research grade evidence generation, scientific communications, and medical compliance strategies. Marimac’s senior scientists and experienced professionals help organizations develop clear guidelines, detailed literature and claims review, data visualization, and crafted audience-specific messaging to support their high-priority content initiatives.
At Vodori, we make it easy for life science companies to move fast–because healthcare can’t wait. We empower companies to move quickly with cloud software that is innovative, life-science focused, and delivered with an exceptional customer experience.
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