eCOA: Has It Lived Up to the Promise? A Realistic Assessment for Today’s Trials

Dawn Jordan, Associate Director, COA Oversight & Linguistic Validation, Takeda

Dawn Jordan is Associate Director, COA Oversight & Linguistic Validation at Takeda, where she’s built a team supporting the delivery of high-quality clinical outcome assessment content across clinical research programs. She brings nearly 20 years of experience in scientific and medical translation, with expertise spanning both sponsor and vendor perspectives. Her COA experience encompasses the full spectrum, from paper COA development through eCOA implementation.

Before joining Takeda, Dawn led the Scale Management team at WCG Clinical, overseeing paper COA development, linguistic validation, and the electronic implementation of translations. She previously served as Head of the Translation Department at Ubiqus USA, where she led a cross-national team of project managers supporting a broad range of translation initiatives, from medical devices to media and entertainment.

Dawn also brings a strong academic background to her work, having served as a Lectrice at INSA Lyon and as an adjunct instructor at NYU’s School of Continuing and Professional Studies. Her career reflects a deep commitment to language quality, cross-cultural communication, and the integrity of translated materials in scientific and educational settings.

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

Paul O’Donohoe is currently a Senior Director of 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 electronic clinical outcome assessment technologies and supporting internal teams and partners in implementing industry, regulatory and scientific best practices in clinical trials using mobile health technologies. Paul is passionate about advancing the field of eCOA and mobile health through research and active involvement in industry consortia. He previously served as Industry Vice-Director of the C-Path ePRO Consortium. Earlier in his career, Paul worked as a Research Psychologist at a child and adolescent mental health clinic in Dublin, Ireland. He later moved into the health consulting field with United BioSource Corporation, where he worked across health outcomes, health economics and health data capture groups. Prior to joining Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he led the health outcomes team. He holds an MSc in Cognitive and Clinical Neuroscience.

Mark Wade, Global Practice Leader & COA SME, TransPerfect Life Sciences

Mark P. Wade is the Global Practice Leader at TransPerfect Life Sciences, the largest language translation company globally, where he serves as the resident SME for all patient-facing clinical trial processes and translation. Mr. Wade has 20 years of experience in life sciences, including serving as International Regional Director for EMEA at Ethicon and Ethicon Endo-Surgery, a Johnson & Johnson company (NYSE: JNJ). For nearly 10 years, Mr. Wade served as Global Practice Leader at another global language translation company. He is a published expert in electronic clinical outcome assessments (eCOA), including two eBooks, as well as clinical services, patient recruitment and site selection. He has also authored clinical posters and numerous articles in trade journals. Mr. Wade has chaired sessions, presented and published posters at ISPOR and ISOQOL annual symposia, as well as numerous other internationally recognized conferences. He is a past industry Co-Director and an active Committee Member of the C-Path eCOA Consortium, the ISOQOL Translation & Cultural Adaptation (TCA) Special Interest Group (SIG) and the ISPOR Digital Health (DH) SIG.