09.13.25 -- Clinical Leader, The Best Of August

As CROs evolve beyond traditional service roles, many are investing in proprietary or semi-integrated site networks to streamline trial delivery, improve patient access, and boost data consistency. This article explores how major players like ICON, Parexel, PPD, and Syneos Health are building or partnering with site networks—sometimes through direct ownership, sometimes through curated alliances.

Consultant Jessica Cordes provides an update on proposed changes to GMP guidance that affect trial conduct, including documentation, computerized systems, and the use of AI.

Adam Kinsey described how sponsor-site partnerships at Merck typically start small. Sites are evaluated not only on enrollment but on predictability and communication throughout a study.

Project Optimus represents a transformative shift in oncology, advocating for a more nuanced, evidence-based approach to dose selection, prioritizing patient safety alongside treatment effectiveness.

Critically examine prevalent myths surrounding electronic Trial Master Files (eTMFs) and their integration with electronic Investigator Site Files (eISFs).

Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.