Regulatory Readiness: Best Practices For Clinical Trial Compliance

Let’s face it: Clinical trials and, to some extent, their sponsoring companies can live and die by decisions made by the FDA. And while regulatory matters simultaneously motivate and strike fear in the folks working in regulatory and compliance roles, clinical research professionals across functional areas are best served when they too stay abreast of the FDA’s every move.

But it’s not enough to simply stay informed. Clinical researchers must seek out and equip themselves with best practices that allow them to be as successful as possible when it comes to meeting federal regulations for drug development and approval.

That’s why we’ve compiled a handful of the most helpful guest expert articles doing just that. Several of our most reliable regulatory experts offer their expertise to help sponsor organizations prepare for bioresearch monitoring (BIMO) program inspections, develop a Risk Evaluation and Mitigation Strategy, keep tabs on the trends in FDA warning letters, and understand the current state of compliance scrutiny.

Wrapping up this e-book is critical look at the Food and Drug Omnibus Reform Act of 2022 (FDORA) and what it means in terms of alternative inspection tools, foreign government inspections, and regional compliance history.