Donna Libretti Cooke, JD

Redesigning clinical trial access through strategy, research, and partnership

Chief Impact Officer and Owner, ImpactSphere™ Clinical, LLC

Donna Libretti Cooke, JD

In Her Words

I founded ImpactSphere™ Clinical to help sponsors, CROs, patient organizations, nonprofits and innovators redesign clinical trial access through participant-centered strategy.

Drawing on more than 15 years of experience in global clinical operations, original industry research, and lived patient experience, I work across the entire Clinical Trial Access Continuum™ — connecting eligible participants to the right trials, supporting them throughout the research journey, and extending the impact of clinical trials beyond their conclusion.

My goal is simple: help organizations design clinical trials that work better for the people they are intended to serve.

The Path Here

My Journey Was Never Linear

My career has never followed a straight line — and that's exactly what makes my perspective different. Beginning as an attorney, I moved through legal and regulatory conference development, healthcare compliance, site contracting and budgeting, and five years in Rome, with two of them as a Public Affairs Associate with the U.S. Mission to the UN World Food Agencies. Each chapter taught me something different about systems, governance, partnerships, and how complex organizations work.

In Rome, I saw firsthand that even the best intentions fall short if systems aren't designed to deliver support to the people they are intended to serve. That lesson stayed with me throughout my career — from sponsor-side clinical operations to my research and industry collaborations — and ultimately inspired the Clinical Trial Access Continuum™, a framework for redesigning clinical trial access before, during, and beyond the trial.

  1. Attorney

    Rigor, evidence, and how the rules quietly shape outcomes.

  2. Conference Development

    Turning market intelligence and regulatory complexity into information people could act on.

  3. Healthcare Compliance

    Where good intentions meet real-world governance.

  4. Rome — U.S. Mission to the UN

    Even the best intentions fall short if systems aren't designed to deliver.

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    Working in public affairs at the U.S. Mission to the UN Food & Agricultural Agencies gave me a front-row view of how policy, partnerships, governance, and communications intersect to address complex global challenges. It reinforced a lesson that still shapes my work today: meaningful impact requires systems designed to reach the people they are meant to serve.

  5. Site Contracting & Budgeting

    Where I saw how operational decisions can directly shape the participant experience.

  6. Global Clinical Operations + Kits4Life℠

    Where I learned that clinical operations could create impact far beyond the trial itself.

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    Led global clinical operations initiatives spanning 40+ countries while implementing and scaling Kits4Life℠ — an award-winning model for transforming unused clinical trial supplies into humanitarian impact.

  7. Participant Payment Research

    Where questions from operational experience became evidence — and a catalyst for change.

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    Questions that emerged from my clinical operations experience led me to investigate what sponsors were actually paying clinical trial participants — and how little visibility existed across the industry. That work grew into original research, published analyses, and industry collaborations focused on building the evidence needed to advance more equitable and participant-centered payment strategies. Over time, this work — combined with years of regulatory, ethics, operational, and industry intelligence — also informed the development of Participant Support Intelligence™, an AI-enabled decision-support capability designed to translate complex information into practical guidance, country-level intelligence, and tools for developing participant payment and support strategies.

  8. ImpactSphere™ Clinical, LLC

    Where experience, evidence, and strategy came together to redesign clinical trial access.

  9. Clinical Trial Access Continuum™

    One framework: before, during, and beyond the trial.

Why This Work Matters

Both professional and deeply personal

My passion for redesigning clinical trial access is both professional and deeply personal. As a triple-negative breast cancer survivor, I experienced firsthand the uncertainty, vulnerability, and practical burdens that patients often face while navigating healthcare. That experience reinforced what years in clinical operations had already taught me: participant support should never be an afterthought.

Today, I bring both perspectives to my work — as a clinical operations strategist and as a volunteer Patient Educator with The Women's Cancer Teaching Project, where I share my lived experience with medical and nursing students to help shape more compassionate future healthcare professionals. Together, those experiences continue to inspire my commitment to designing clinical trials that work better for the people they are intended to serve.

Research & Industry Leadership

The collaborations that shape this work

Donna Libretti Cooke presenting on a participant payment strategy panel at the DIA 2026 Global Annual Meeting
Presenting on global participant payment strategy at the DIA Global Annual Meeting.

Equitable Access to Clinical Trials (EACT) Project

Project member and steering committee

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Coalition to Transform Clinical Trial Engagement

Participant Compensation & Benefits Working Group — Ignore No More

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DIA Participant Payment Consortium

Member — led the consortium landscape analysis on participant compensation

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Tufts Center for the Study of Drug Development (CSDD)

Participant compensation data study collaboration

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Education

  • JD, Washington College of Law, American University
  • Phi Beta Kappa, Rutgers University
  • Healthcare Compliance Certification, Seton Hall Law

Recognition

  • U.S. Chamber of Commerce Citizens Award — Best Health & Wellness Program (2021)
  • Inaugural winner, WCG Innovation Challenge, for Kits4Life (2022)

Service

  • Patient Educator, The Women's Cancer Teaching Project (10+ years)
  • Speaker at DIA, SCOPE, SCRS, GCSG, and WCG MAGI

Let's start a conversation

If your organization is rethinking how participants find, experience, and benefit from clinical trials, I'd welcome the conversation.

Schedule a Conversation