Receiving a Form FDA 483 can put a lot of pressure on your biopharma organization. Once an inspection is complete, teams are often working against the clock to assess findings, gather documentation, investigate root causes, and determine how to…

Representative enrollment has been a core component of clinical research for years, but with the passage of the Food and Drug Omnibus Reform Act, it’s taken on greater significance, especially for rare disease researchers. Sponsors are now expected to…

The adoption of ICH E6(R3) has led many organizations to update their Standard Operating Procedures (SOPs) and focus more on risk-based monitoring, but one of the biggest changes in the guidance — the expanded role of the medical monitor…

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 leadership informed. But the sites responsible for collecting and reporting that data don’t always…

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 to time spent on site. This approach stayed largely intact even as other areas…

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 to many in clinical research: highly skilled teams operating under chronic stress, increasing the…

In a recent article for Clinical Leader, Mark A. Tobolowsky and Frank J. Sasinowski of Hyman, Phelps, & McNamara shed light on a major regulatory development that could reshape how therapies for ultra-rare diseases reach patients.  That development is…

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. The agency says the goal is simple: to increase transparency and help sponsors better…

New FDA Draft Guidance Aims to Eliminate Labeling Headaches for Drug Developers Submitting a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is no small task. It takes precision, attention to detail, and clear alignment between internal…

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 about the benefits and burdens of involving local healthcare professionals (HCPs) in decentralized clinical…