About This Standards & Guidance
This S&G provides a structured framework to help Medical Affairs, including the Evidence Generation teams, align strategy with patient impact. It offers guidance, rationale for strategic evidence generation planning, as well as tips and tools to support with plan development, and practical guidance for investigator-initiated studies. By following the guidance in this Standards and Guidance document, Medical Affairs professionals can ensure that Non-Company Sponsored Research (NCSR) initiatives drive high-quality, impactful evidence generation that supports scientific advancements, enhances patient care, and aligns with healthcare ecosystem needs.
In this Standards & Guidance you will learn:
This resource has been developed with senior Medical Affairs professionals to provide guidance and recommendations on external scientific engagement for Evidence Generation:
- Why is strategic evidence generation planning important?
- How can an adaptive strategic evidence generation plan be developed?
- How can we ensure our evidence is meaningful for our stakeholders?
- How should evidence gaps be prioritized?
- How can we successfully implement investigator-initiated studies?
- From outputs to impact: How can the value of the evidence be measured?
MAPS would like to thank the following authors:
Eric Maiese
Senior Director & Head US Health Economics & Outcomes Research, Ipsen
Medical Affairs Professional Society
Gary Male
Communications Director, Oxford Pharmagenesis
Medical Affairs Professional Society
Rahul Mandlik
General Manager Medical Affairs, Shalina Healthcare
Medical Affairs Professional Society
Daniel Bin Ng
Senior Director, Head of HEOR International Markets and Greater China, Astellas Pharma Global Development
Medical Affairs Professional Society
Krupa O’Neill
Client Services Director, MEDiSTRAVA
Medical Affairs Professional Society
Phil Wakefield
Chief Advisory Services Officer, Inizio Medical
Medical Affairs Professional Society
