Talk Outsourcing track
Closing the White Space in Fully Outsourced Clinical Trials: Using AI to Detect SOP Gaps, Clarify Accountability, and Strengthen Inspection Readiness
Tue, Mar 2, 2027 · 12:20–12:45 PM EST Rosen Shingle Creek
About this session
In fully outsourced clinical trials, CROs may conduct studies using their own SOPs while sponsors remain accountable for quality, compliance, participant safety, and data integrity. Even after sponsor review of CRO SOPs, audits and inspections may reveal workflow white space, unclear handoffs, or undefined roles. This presentation proposes an AI-assisted approach to compare sponsor and CRO SOPs, identify accountability gaps, and create risk-based oversight plans before compliance issues emerge.
Speaker
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Associate Director, Statistical Programming, Alexion · AstraZeneca Rare Disease
Speaker