Why Level Setting around Site Technology May Be The Most Overlooked Step in Clinical Trial Planning

Beth Harper, Senior Research Consultant, Tufts Center for the Study of Drug Development

Beth is a seasoned clinical research professional who has held multiple roles across all types of organizations (sites, CROs, sponsors and service providers) throughout her 40-year career. She has passionately pursued opportunities to optimize the clinical trial process, accelerate patient enrollment, enhance sponsor/site relationships and to build the competency of the clinical trial workforce.

She is a Senior Research Analyst for the Tufts Center for the Study of Drug Development (CSDD) and the President of Clinical Performance Partners, Inc. Beth received her BS in Occupational Therapy from the University of Wisconsin and an MBA from the University of Texas.

Deena Bernstein, Vice President of Account Development, Transformative Pharmaceutical Solutions (TPS)

Deena is a Healthcare Executive with more than twenty-five years of experience across clinical research site development, operations and digital technology. As Vice President of Account Development at Transformative Pharmaceutical Solutions (TPS), she partners with sponsors on their priority programs to provide managed, embedded solutions that drive and accelerate clinical research. TPS delivers experienced, dedicated clinical teams embedded directly into sponsor operations and site partners, offering a cost-effective, customized approach to meeting sponsor goals and advancing drug development.

Deena’s career reflects a rare breadth of perspective across development sites and operations, sponsor-facing client partnerships and decentralized clinical trial infrastructure. Her executive and leadership roles at Large Healthcare institutions, IQVIA, IROs, Datacubed Health and as an Independent Consultant give her a grounded, cross-functional view of what it takes to drive clinical trials toward sponsor goals and accelerate the path to meaningful results.

She serves on the SCRS Leadership Council, leads industry initiatives through DTRA, holds a Non-Scientific Board seat with Univo IRB and is a Site Luminary for ClinEco.

Jill Bell, PhD, Chief Scientific Officer, Evinova

With more than 20 years of scientific research experience across academia and industry, she has extensive expertise in the design and delivery of end-to-end evidence-generation strategies fit to support and accelerate clinical benefit and treatment value proposition. Dr. Bell is a recognized leader in measurement science and endpoints, patient-centred drug development and the strategic integration of scientific innovation and digital solutions in clinical trials.

Dr. Bell brings subject-matter expertise in clinical trials and evidence generation across multiple other therapeutic areas. With extensive experience in end-to-end clinical development and document authoring, Dr. Bell applies deep expertise in measurement science, behavioral science and quantitative analytics to drive innovative digital health applications in clinical trials and care contexts to ensure that all Evinova products have the right scientific foundations to augment clinical submissions, improve patient outcomes and support evidence-based decisions.

She regularly disseminates scientific learnings through conferences, publications and multidisciplinary collaboration. Her contributions support informed decision‑making across drug development and help transform the experiences of patients, caregivers and clinical teams.

Elisabeth Piault-Louis, Pharmaceutical industry leader specializing in clinical outcomes assessment (COA) and digital science

Elisabeth is a pharmaceutical industry leader specializing in clinical outcomes assessment (COA) and digital science, with a track record spanning biopharma, CROs, non-profit, and the US FDA. Over 20 years, she has served as a subject-matter expert in patient-experience evidence generation—including 11+ years in pharma, 8 years in COA development, validation and interpretation, a year in non-profit, and two years as an FDA COA reviewer—while managing and developing teams for 15+ years. At Evinova and AstraZeneca, she has driven digital innovation to transform clinical trials through decentralized, patient-generated data, remote patient monitoring, and real-time data visualization by HCP to improve patients outcomes; Her expertise spans qualitative science, psychometrics, and the design of regulatory- and market-access–ready measurement strategies, with a consistent focus on patient- and HCP centric experience for optimal insights or evidence.