Donna Libretti Cooke, JD, is Chief Impact Officer and Owner of ImpactSphere® Clinical, LLC, a strategic advisory practice dedicated to redesigning clinical trial access across the entire Clinical Trial Access Continuum™ — before participation begins, throughout the participant experience, and beyond trial completion.

She advises sponsors, CROs, technology companies, and industry organizations on participant-centered strategies that span the continuum: AI-enabled patient matching before the trial; the Whole-Person Participant Support™ framework and Participant Support Intelligence™ — her AI-enabled decision-support system for ethical, operationally grounded participant support — during teh trial; and Kits4Life humanitarian stewardship beyond it.

Donna spent over fifteen years in clinical research operations, most recently at Bayer Pharmaceuticals, where she led participant payment strategy and global contracts and budgets across 40+ countries and implemented the award-winning Kits4Life program (donation of unused clinical trial supplies). She led the DIA Consortium landscape analysis on participant compensation, co-authored AI-driven research analyzing 7500+ informed consent forms, and publishes regularly in Applied Clinical Trials, DIA Global Forum, Clinical Leader, and the Journal for Clinical Studies. Donna has also presented as WCG-MAGI, SCRS, DIA, SCOPE and GCSG events. A triple-negative breast cancer survivor and decades-long Patient Educator with Pathways Women's Cancer Teaching Project, she brings both operational expertise and a patient's perspective to her work.