CDM Role in Late Phase / Safety Registries
Mar 25
10:00 A.M. -
10:45 A.M.
Late phase trials, also called as Post Marketing Surveillance (PMS) Studies, are often observational where the effectiveness of a device/ drug is measured across the long duration of its exposure in general population. As late phase trials are becoming a necessity and a requirement by FDA, the role of CDM is also becoming challenging.

Key Learnings from the Session

  • Challenges in conducting late phase studies
  • Strategies to overcome CDM challenges to ensure data quality
  • Case studies to demonstrate how these strategies can work in real world scenarios

Speaker Profile

Swati Tare

Manager - Data Management

A biochemist by education (Ph.D), Swati has about 18 years of industry experience in pharmaceutical and clinical research area. She has worked with many pharma companies and has successfully handled projects on data migration, hybrid studies (paper – RDC), fast track studies in data management and screening assays for new chemical entities for diabetes.

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