Join us on September 18th where our panel of experts will unlock insights on how the FDA view the collection of patient-reported outcomes (PROs) for real-world evidence. This webinar will delve into critical FDA comments & guidance on PRO data collection methods, timing, and quality, while keeping participant experience as priority number one.
Expert Panel
- Ari Gnanasakthy, Principal Scientist, Patient-Centered Outcomes Assessment, RTI Health Solutions
- Willie Muehlhausen, Co-CEO, Safira Clinical Research Ltd.
- Derk Arts, Founder & CEO, Castor
Why attend?
Patient-reported outcomes are crucial in shaping regulatory decisions and drug development strategies. However, navigating the FDA’s expectations and optimizing data quality can be challenging. This webinar, will help you understand:
- Key FDA Insights: Discover what recent FDA review documents reveal about PRO data quality and regulatory expectations.
- Timing & Methods for PRO Collection: Learn when and how PRO data should be collected to ensure accuracy and compliance.
- Improving Data Quality: Find out the best practices for minimizing errors and enhancing data reliability.
- Addressing ePRO Fatigue: Understand the common pitfalls in ePRO collection and how to overcome them.
- The Role of Tolerability Data: Explore why tolerability data is becoming increasingly important and how it can differentiate your drug.
Who should attend?
- Clinical researchers and trial managers
- Real-world evidence teams
- Medical affairs and HEOR professionals
- Patient engagement specialists
- Anyone interested in enhancing their understanding of PRO data collection
Don’t miss this unique opportunity to peek behind the regulatory curtain, get some blue sky thinking, and learn how to align your data strategies with FDA expectations. Register now to reserve your spot >
