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ClinAudits’ Audit Notes Sponsor Oversight in Outsourced and Virtual Trial Models – Raising the Bar in GCP Auditing As the clinical research landscape rapidly evolves, sponsors are increasingly outsourcing operational responsibilities to CROs, technology providers, and virtual trial vendors. While this model offers scalability and innovation, it also introduces new complexities in Good Clinical Practice…
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ClinAudits’ Audit Notes. The Current State of FDA REMS Auditing: A Strategic Insight When Working with Auditing Firms. Executive Summary In the evolving landscape of pharmaceutical regulation, Risk Evaluation and Mitigation Strategies (REMS) have become a critical component of the U.S. Food and Drug Administration’s (FDA) drug safety oversight. As drug therapies grow more complex…
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ClinAudits’ Audit Notes ✅ GCP Compliance Starts with a Complete, Audit-Ready TMF. Your Clinical Trial’s Integrity Depends on It. Our Experts Ensure It’s Done Right. Maintaining a complete and inspection-ready Trial Master File (TMF) is not just a regulatory requirement, it’s the backbone of clinical trial credibility, patient safety, and sponsor confidence. At ClinAudits, we…
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Is Your Informed Consent Process Truly Compliant? Partner with Experts in GCP Auditing to Protect Your Trial Integrity. In clinical research, informed consent is more than a signature, it’s a cornerstone of ethical and regulatory compliance. Yet, many organizations unknowingly expose themselves to risk due to outdated, inconsistent, or non-compliant consent procedures. At ClinAudits, we…
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