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

Eric Maiese

Senior Director & Head US Health Economics & Outcomes Research, Ipsen
Gary Male

Gary Male

Communications Director, Oxford Pharmagenesis
Rahul Mandlik

Rahul Mandlik

General Manager Medical Affairs, Shalina Healthcare
Daniel Bin Ng

Daniel Bin Ng

Senior Director, Head of HEOR International Markets and Greater China, Astellas Pharma Global Development
Krupa O’Neill

Krupa O’Neill

Client Services Director, MEDiSTRAVA
Phil Wakefield

Phil Wakefield

Chief Advisory Services Officer, Inizio Medical