PODCAST SERIES: When Methodology Meets Technology: Exploring how intelligent trial design and digital agility reshape clinical trials
Accelerated approval pathways can help bring treatments to patients sooner—but accelerated timelines require trustworthy evidence, standardized data and technology built for faster regulatory readiness.
Episode 3: From Data to Delivery: EDC’s Role in Accelerated Approvals and Trustworthy Evidence
From surrogate and intermediate endpoints to data transparency and submission standards, the IDDI and Marvin EDC experts examine what it takes to build trustworthy evidence on accelerated timelines and discover why planning for regulatory submission from the start can help teams move from promising early signals to reliable evidence—and ultimately bring treatments to patients sooner.
Speakers:
- Leandro Garcia Barrado, Principal Statistical Scientist, IDDI
- Nicole Kuisle, Head of Customer Success, Marvin EDC by AB Cube
Key Learnings:
- Understand accelerated approval pathway: Using earlier endpoints to support earlier access to promising treatments
- Explore strategies for confirmatory evidence: From separate trials to adaptive seamless designs
- See why data transparency and standardization matter: Building trustworthy evidence for regulatory decisions
- Plan for submission readiness from the start: Aligning EDC design, data standards and workflows early
- Use EDC as a strategic enabler: Supporting real-time data visibility, transformation and accelerated timelines
Watch episode 1: From Protocol to Platform: Flexible Randomization and Seamless Design in Practice
Watch episode 2: Turning Data Into Decisions: Real-Time Reporting Meets Group-Sequential Designs
Continue the conversation at our upcoming webinar:
Project Optimus Meets EDC: Operationalizing Optimal Dose Trials from Design to Data
Thursday 15 October | 4pm CET / 10am ET
About the podcast series:
When Methodology Meets Technology explores how intelligent trial design and digital agility can work together to address the growing complexity of clinical research. Across three episodes, experts from IDDI and Marvin EDC discuss how statistical innovation, connected data and flexible technology can help translate advanced trial designs into clinical practice.
