08.09.25 -- Clinical Leader, The Best Of July

RSM US LLP Life Sciences Senior Analyst Amanda Laskey discusses Trump administration tariffs and how they're expected to impact the pharma world, specifically clinical research.

In October, the FDA took a significant step forward by releasing a new Q&A guidance clarifying the use of electronic systems, e-records, and e-signatures in clinical investigations.

Too often, clinical operations is treated as a transactional or downstream function, says clinical operations strategist Suzanne Vyvoda. She wants to change how we see and treat ClinOps.

In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.

Learn the distinctions between a Waiver of Consent and a Waiver of Written Consent in clinical trials, and the importance of informed consent, particularly in the context of virtual trials.

The initial IRB submission process can involve common challenges. To help you overcome these obstacles, discover seven fundamentals you should know about a successful initial IRB submission.