Tag: CRO data integrity issues

Ensuring 21 CFR Part 11 Compliance in CRO-Managed Platforms

Posted on digi By digi

Ensuring 21 CFR Part 11 Compliance in CRO-Managed Platforms Achieving 21 CFR Part 11 Compliance in CRO eTMF and EDC Platforms Introduction: Why Part 11 Compliance Matters for CROs Contract Research Organizations (CROs) play a critical role in clinical trial execution, often managing essential systems such as Electronic Trial Master File (eTMF), Electronic Data Capture…

Read More “Ensuring 21 CFR Part 11 Compliance in CRO-Managed Platforms” »

CRO Audits, CAPA, and Deviation Management, Data Integrity & Systems Oversight

Sponsor Oversight of CROs: Regulatory Expectations and Best Practices

Posted on digi By digi

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,…

Read More “Sponsor Oversight of CROs: Regulatory Expectations and Best Practices” »

Clinical Trial Operations & Compliance, Vendor Oversight & CRO Compliance