Designing Smarter Participant Support Systems for Modern Clinical Trials
Improving access to clinical trials through Whole-Person Participant Support™, ethical participant payment strategies, AI-enabled patient matching, and innovative clinical operations models that reduce financial and logistical barriers.
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Donna Libretti Cooke, JD
Chief Impact Officer & Owner
Core Focus Areas
Three Interconnected Disciplines
Participant Payment Strategy
Ethical, operational, and globally informed compensation approaches grounded in financial neutrality and participant dignity.
Learn moreWhole-Person Participant Support™
Operational frameworks designed to address the full range of participant burdens throughout the clinical trial journey.
Learn moreParticipant Support Intelligence™
An emerging AI-enabled decision support system designed to help sponsors navigate participant support strategy across countries, regulations, and operational realities.
Learn moreThe Challenge
Why This Matters
The industry invests billions in the science of clinical trials. The experience of the people inside them deserves the same rigor.
86%
of protocols have become more complex over the past decade
30–40%
of participants drop out before trial completion
#1
barrier to enrollment cited by participants: financial and logistical burden
< 5%
of clinical trial participants reflect the full diversity of patients they're meant to serve
40+
countries analyzed in Donna's global participant payment mapping initiative at Bayer
Thought Leadership
Featured Publications
DIA Global Forum · December 2024
Breaking Financial Barriers: Making the Shift to Reasonable Compensation for Clinical Trial Participants
Industry Publication · 2024
Static Reimbursement Structures Aren't Enough: Patients Need Whole-Person Support
Applied Clinical Trials Online Webinar · September 2025
Strategic Participant Payments for Twenty-First Century Clinical Trials
Journal for Clinical Studies, Vol. 16, Issue 2 · 2024
Reviewing Research Participants Payments Through a Diversity Lens
Featured Framework
Whole-Person Participant Support™ Framework
Co-developed with two industry colleagues, the WPPS™ Framework is a sponsor-embedded operating model that helps clinical trials address real participant burdens through adaptive support systems — including responsible engagement with nonprofit organizations.
The framework challenges sponsors to move beyond reimbursement and address the full spectrum of financial, logistical, and human barriers that participants and their families face.
Explore the Framework
Humanitarian Innovation
Expanding Access Beyond the Trial Itself
Donna helped launch and scale the Kits4Life initiative — an innovative humanitarian program focused on repurposing surplus clinical trial supplies for global health and educational use. Originally developed during her time at Bayer, the program brought together pharmaceutical sponsors, nonprofit organizations, and operational stakeholders to create a scalable donation model.
Her work includes new business development, sponsor engagement, onboarding strategy, community-of-practice leadership, and development of scalable onboarding tools to support broader industry adoption.
Bayer winner of U.S. Chamber of Commerce Citizens Award (2021)
WCG Innovation Challenge Top Winner for Kits4Life (2022)
A Guiding Principle
"Participant support should not be an afterthought. Ethical, operationally feasible support strategies can improve both participant experience and trial execution. So no participant carries the financial cost of advancing medicine. And so trials reflect the patients they're meant to serve."Schedule a Conversation