All Content Clinical Leader

  1. The FDA's New Guidance May Be Shaking Up Biotech 7/25/2025

    The FDA’s recent draft guidance on accelerated approval outlines tougher standards for confirmatory trials and introduces a faster process for withdrawing approvals.

  2. Designed To Help Sites Increase Clinical Trial Capacity 7/25/2025

    IQVIA One Home for Sites is a platform that serves as a neutral aggregator, connector, and communicator of the key systems and tasks a clinical research site needs to perform across all the trials it is conducting.

  3. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

    ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.

  4. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

    A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

  5. All Of Us Need To Be Rooting For The FDA 7/23/2025

    In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.

  6. Why Is Hep C Still On The Rise? And What Atea Is Doing About It 7/22/2025

    Atea Pharmaceuticals Chief Development Officer Janet Hammond, MD, Ph.D., discusses why current DAAs aren't adequately addressing the rise in hepatitis C and how Atea is hoping to curb the increase.

  7. DCT Benefits Are Proven, Yet Progress Is Slow 7/21/2025

    Despite the clear benefits of decentralized trials—broader reach, better retention, and higher diversity—adoption has been slow. In this interview, Sunny Kumar of Informed Ventures explains how AI is lowering costs, speeding up study builds, and pushing DCTs from fringe to future.

  8. All You Need To Know About 505(b)(2), But Were Afraid To Ask 7/18/2025

    Join us to explore the 505(b)(2) pathway. Learn how to bring improved drugs to market faster, reduce costs, and add value with this streamlined regulatory approach.

  9. Trials Without Borders: A Webinar Series From Clinical Leader And FlexPoint Bio 7/18/2025

    Trials Without Borders is a multi-episode webinar series hosted by Dan Schell, chief editor of Clinical Leader, and Elena Sinclair, principal consultant at FlexPoint Bio. The series will address the challenges and benefits of running clinical trials in countries such as Australia and Canada and include interviews with SMEs who have experience with these types of trials.

  10. New Purpose-Built Facility For Large-Scale Sterile Fill/Finish Operations 7/17/2025

    Expanding capacity for late-phase clinical and large-scale commercial small molecule and biologic drugs, a new facility boosts sterile fill/finish capabilities.