Regulatory & Compliance Oversight | The NIH recently reclassified BESH studies as non-clinical trials, reducing registration and reporting burdens, while simultaneously aligning its “intervention” definition with the 2018 Common Rule, expanding the scope of clinical trials. These...
Regulatory & Compliance Oversight Clinical Trial Compliance: Preparing for FDA Inspection Readiness Being “inspection ready” isn’t just about preparing when the FDA calls — it’s about embedding compliance into daily clinical trial operations. This article explores practical...