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New FDA Draft Guidance Aims to Eliminate Labeling Headaches for Drug Developers Submitting a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is
How to Centralize Credential Verification for Local HCPs in Decentralized Clinical Trials (DCTs) In a recent article, Dan Schnell, Chief Editor at Clinical Leader, talked
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