DIA: Driving Insights to Action
Science:Life Sciences
Even under COVID-19 quarantine, patients wearing remote sensors keep clinical research moving forward digitally. “Now suddenly, very suddenly, we're faced with an intense patient safety issue where we really are risking patients' lives by having them come into these clinical sites,” explains Paul O’Donohoe, Medidata Solutions. "I suspect we're going to see a significant uptake in the acceptability and use of technology as a way of allowing patients to now provide us that data in the safety of their own homes.” Bill Byrom, Signant Health, moderates this podcast with Paul and Jennifer Goldsack, Digital Medicine Society, and serves on the Steering Committee for the August 2020 virtual Digital Technology in Clinical Trials conference co-sponsored by DIA and the ePRO Consortium of the Critical Path Institute.
Analyzing Innovation’s Progress in Gottlieb Era
Comparing Generic Safety Profile with Branded Cousin
Defining Unmet Need Critical to Determining Value
Triple-A RWE: Adequate Data, Appropriate Designs, Actionable Evidence
US REMS Requirements for NDAs and BLAs
Epoietin Biosimilars: Qualitative Study of Patients' Views
Disparities Between FDA/EMA Review Processes
DIA Japan's Focus in Fall 2018
FDA Leadership on Future Biologics and EMA/FDA Cooperation
Global Perspectives on Patient Engagement
DIA Board Chair Discusses DIA Now and Digital Tomorrow
Integrating Genetic Medicine into Clinical Care
Regulatory Landscape of Drug-Device Combination Products
Value-Based Assessment & Contracting: What Needs to Be Done?
Block Chain, AI, Internet of Things: Future of PharmaTech?
“My Voice Needed to Be Heard”
IMEDS Collaboration Builds Upon Sentinel Surveillance
Crafting Sound Medical Affairs Professionals
Statistical Strategies for Using Sources of Safety Data
Regulatory & Ethical Considerations in a Pediatric Trial
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