Talk Risk-Based Quality Management track
Challenges in SDV & SDR Methodology: Introducing a Technical Solution for Flexible Sampling of SDV & SDR Activity
Tue, Oct 29, 2024 · 3:55–4:20 PM CET InterContinental Barcelona
About this session
Session: RBQM IN A CHANGING REGULATORY LANDSCAPE
Sponsored presentation.
Reduced source document verification (SDV) and review (SDR) approaches differ widely across the industry. Despite reduced methods being recognized as an acceptable approach, there are still challenges with adoption. As a result, there is a high degree of variation between sponsors, and CROs. This presentation will consider the complementary processes of SDV and SDR and introduce a technical solution for providing flexibility, traceability and sampling for management of SDV & SDR activity.
Speaker
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Senior Director · PPD Part of Thermo Fisher Scientific
Speaker