Objectives were:
- To gain perspective on how medical review is being positioned within digital transformation efforts.
- To generate peer discussion around common challenges, operating models, and realities of medical review in today’s regulatory environment.
- To explore real-world perspectives on the role and limitations of Artificial Intelligence in supporting medical review workflows.
Abstract
As pressure mounts to accelerate content delivery and explore the possible use of Artificial Intelligence (AI), Medical Affairs organizations are examining how digital transformation intersects with existing medical review processes. A recurring question is whether and how organizations are viewing digital transformation efforts alongside existing medical review models.
Organizations expect medical review to function as a strategic capability, yet many experience it as a fragmented or downstream process, creating challenges related to consistency, resourcing, and leadership burden. Before AI can meaningfully enhance review workflows, organizations are grappling with how, or if, AI can effectively support medical review.
This discussion explored how organizations position medical review today and what role it plays in enabling responsible innovation. Drawing on participants real-world experience and peer-to-peer dialogue, participants shared what works, what doesn’t, and how they are navigating the balance between innovation, scientific rigor, and regulatory accountability.
Participants brought diverse perspectives shaped by decades of experience across multiple organizations, highlighting the variability in how the industry structures, executes, and values medical review.
While best practices are emerging, many organizations are still navigating the gap between ideal-state medical-review models and real-world operational constraints.
Executive Summary
- Canopy conducted this session to validate what needs to be true if advanced technologies are to bring added value to the Medical Legal Regulatory (MLR) process and, more specifically, to medical review.
- We grounded the session in establishing how the current positioning of medical review can facilitate improvements through digital transformation, or Artificial Intelligence more directly.
- Operational realities of MLR review and growing complexities of content management are barriers to AI adoption.
- At the same time, participants identified a clear need to maximize the value of their time through quality control and reduced manual effort.
- For technology and, more specifically, Artificial Intelligence to positively impact medical review or MLR broadly, it needs to offer real value to the human reviewers accountable for the process.
Model for Discussion
- Defining the Problem -> What Possible Solutions Exist -> What, If Any, Recommendation Could Drive Improvement
Defining the Problem
Medical, Legal, and Regulatory (MLR) review is a collaborative review process designed to ensure medical and commercial messaging is scientifically supported, adherent to relevant regulations, and in line with corporate risk tolerance. Under ideal conditions, MLR teams operating with well-aligned workflows, healthy collaboration, and clear communication priorities get efficient, high-quality communication to HCPs, patients, and caregivers.
In practice, MLR teams and our medical review colleagues share a set of common barriers:
Right Person, Right Role, Wrong Skill Set
Medical Directors, recruited for their clinical acumen and therapeutic expertise, may have a knack for collaboration and content review, but the truth is that most of them aren’t excited by this type of work – no matter how objectively important it is. A lack of real training or mentorship focused on medical review and its associated regulations tends to increase the general dread. Becoming truly accomplished at medical review requires above-average commitment, especially in a resource-constrained environment.
INTERESTED IN HOSTING A ROUNDTABLE?
This article summarizes a Roundtable hosted by a MAPS Partner Circle member that brought together leading experts from across the industry. If you are a solution provider interested in hosting your own Roundtable, please check out our Media Planner or contact Luke with MAPS: [email protected].
