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What are the latest developments at the FDA in risk-based quality management of GCP audits? The U.S. Food and Drug Administration (FDA) has been continuously advancing its approach to Good Clinical Practice (GCP) audits by emphasizing risk-based quality management.  This strategy focuses on identifying and managing potential risks to patient safety and data integrity throughout…
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It is a critical requirement for all external parties (i.e. vendors, partners, suppliers) contributing to the conduct of a clinical trial to be capable, committed, and resourced to meet their contractual responsibilities.  The question is how do you make certain that what has been presented in bid defenses, sales materials, and even previous experience with…
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