Blog

Key performance indicators (KPIs) are an essential part of all clinical research. Sponsors use them to track enrollment, monitor safety signals, manage timelines, and keep

For decades, clinical research associate oversight followed a familiar pattern. Monitoring visits happened regularly, source document verification topped most agendas, and success was often linked

This blog was inspired by a recent article in Clinical Leader by clinical operations expert Rita Birdi. In the piece, Birdi highlights a challenge familiar

In a recent article for Clinical Leader, Mark A. Tobolowsky and Frank J. Sasinowski of Hyman, Phelps, & McNamara shed light on a major regulatory

In a move drawing attention across the biopharmaceutical industry, the FDA recently released more than 200 complete response letters (CRLs) issued between 2020 and 2024.

New FDA Draft Guidance Aims to Eliminate Labeling Headaches for Drug Developers Submitting a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is