Efficient eCOA Implementation in Clinical Trials

Paul O’Donohoe, Senior Director, eCOA Product and Science, Medidata

Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata’s eCOA technologies and supporting internal teams and partners around the implementation of industry, regulatory and scientific best practices in clinical trials using mobile health technologies.

He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and was previously the Industry Vice-Director of the C-Path ePRO Consortium.

Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation, where he worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health (now Signant Health), an eCOA provider, where he led their health outcomes team. He has an MSc in Cognitive and Clinical Neuroscience.

Dr. Holly Robertson, Head of Advisory Services, Medidata

Dr. Holly Robertson is the Senior Director of Advisory Services at Medidata where she leads a team of subject matter experts, providing guidance to clients and partners in adopting decentralized clinical trial (DCT) strategies and technologies. Since 2015, Dr. Robertson has led multi-disciplinary teams in developing operational strategies for DCTs, including the ADAPTABLE study — the industry’s first and largest fully decentralized clinical megatrial. She has worked collaboratively with sponsors, sites, patients, ethics committees and technology companies to pioneer successful strategies in changing the clinical trial landscape.

Dr. Robertson has over 20 years of experience in pre-clinical, translational and clinical research at leading academic institutions, including the University of Colorado Health Sciences Center, the McGovern Institute for Brain Research at Massachusetts Institute of Technology (MIT) and Duke Clinical Research Institute (DCRI). She is passionate about developing patient-centered technologies that improve the design and execution of clinical studies, ease patient participation and accelerate commercial outcomes to improve patient health.

Ethan Zastrow, Associate Manager, Instrument Services, Medidata

Ethan Zastrow is the Associate Manager of Instrument Services at Medidata Solutions. His team is responsible for the electronic implementation of clinical outcome assessments (COAs), including instrument licensing, translation and digital adaptation.

Prior to joining Medidata, he worked as a Project Manager and Account Lead for RWS Group, a language service provider specializing in the linguistic validation of COAs.

Michael Chou, Associate Director, Advisory Services, Medidata

Michael is an Associate Director of Advisory Services at Medidata, delivering critical guidance for next generation clinical trial technology adoption. His broad yet deep understanding of the patient, site, and sponsor experience comes from nearly two decades of leading clinical SaaS transformation with sponsors and CROs.