Sponsor Oversight of CROs: Regulatory Expectations and Best Practices
Sponsor Oversight of CROs: Regulatory Expectations and Best Practices Regulatory Expectations and Best Practices for Sponsor Oversight of CROs Introduction: The Sponsor’s Accountability The delegation of trial conduct to Contract Research Organizations (CROs) is common across the pharmaceutical industry. However, sponsors remain ultimately responsible for compliance with 21 CFR Part 312 in the United States,…
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