DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner, ImpactSphere Clinical, LLC

EMAIL: dlibretticooke@gmail.com

CONTACT PHONE: 973-437-6718

PROFILE:  A compassionate pioneer driving clinical trial solutions for a healthier world.

Donna is a strategic and collaborative Life Sciences professional with a ‘dive-in’ mindset and an extensive track record of successfully driving impactful solutions related to Clinical Operations, Site Sustainability, Patient Reimbursements & Engagement and Corporate and Social Responsibility. Donna has had a ‘squiggly line’ career path, as she pivoted from a former practicing attorney into legal conference development, a foray as a diplomat in Rome, and a career move back into specializing in Clinical Operations in Life Sciences. Donna spent the past 8+ years at Bayer, growing, developing and managing Contracts, Budgets & Payment teams.  Her latest role for 5+ years was in a new, centralized role as the Director of the Global Contracts & Budgets team for Phase II – III clinical trials and Phase I oncology studies.  Donna’s role garnered increasing levels of responsibility and ability to drive strategic direction for the organization related to site sustainability, patient engagement and corporate & social responsibility. She was the Project Lead for new initiatives such as automated site payments, Veeva contracts & budgets workflow and led the operationalizing of a patient reimbursement vendor.  

Donna’s pride and joy was leading the successful implementation of Kits4Life at Bayer, which is a cross-sector collaborative initiative that enables Bayer to donate unused clinical trial supplies for humanitarian aid. Donna’s efforts led Bayer to be recognized for two industry awards for these efforts.  

Donna currently provides specialized services as a subject matter expert in operationalizing participant support programs, reimbursement vendors, other Clin Ops support (contracts, budgets, site payments) and Kits4Life - a sustainability in clinical research platform for donating unused clinical trial supplies for humanitarian aid. 

PATIENT ADVOCACY

Patient Educator Volunteer & Member of Advisory Council – Pathways Women’s Cancer Teaching Project (Summit, NJ) (2014 – Present) Shares her experience as a triplenegative breast cancer survivor to medical students, residents and nurses, providing teachings about patients’ personal experiences through educational dialogue in a less formal setting.  

ARTICLES:

• Breaking Financial Barriers: Making the Shift to Reasonable Compensation for Clinical Trial Participants (DIA Global  Forum Dec 2024)
• How Did Clinical Researchers Actually Use AI In 2024 (Clinical Leader)
• Reviewing Research Participant Payments Through a Diversity Lens (Journal of Clinical Studies)
• Participant Payments Pulse Check: How and Why to Prioritize Your Strategy (clinicaltrialvanguard.com) 
• Donating Surplus Clinical Trial Supplies Is Sustainability’s “LowHanging Fruit” (clinicalleader.com)

SPEAKING ENGAGEMENTS

• WCG-MAGI  
• SCOPE
• SCRS

EMAIL: dlibretticooke@gmail.com

CONTACT PHONE: 973-437-6718

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