Clinical Data Management Featured Articles

  1. How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1) 2/12/2026

    Learn how the EU AI Act reshapes the regulatory treatment of AI-enabled eTMF systems with consultant Donatella Ballerini.

  2. How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2) 2/12/2026

    Learn how to comply with the EU AI Act when AI is used in GCP-critical eTMF contexts in part two of this series by Donatella Ballerini.

  3. 4 Factors Changing The Way CRAs Monitor Trials 1/28/2026

    The way CRAs monitor is about to change. Regeneron's Patrick Floody discusses these four factors that will influence it.

  4. Will New AI Health Assistants Suggest Clinical Trials To Inquiring Patients? 1/27/2026

    New AI health assistants are now doing even more to help patients make sense of symptoms, diagnoses, and treatment options. What does that mean for the discoverability of clinical trials?

  5. 3 Clinical Research Attorneys Talk 2026 Trends 1/23/2026

    Three life sciences legal experts share what they see happening in the year ahead — and what should remain firmly in the past. 

  6. Digital Protocols Are At An Inflection Point: A Conversation With Novartis And TransCelerate Leaders 1/23/2026

    Digital protocols could reduce manual effort and enable rapid and more consistent downstream study execution, reporting, and submission processes. TransCelereate BioPharma's Rob DiCicco and Novartis' Bill Illis explain.

  7. Common Issues And Trends In Clinical Research Vendor Qualification 1/21/2026

    Discover the biggest challenges in vendor qualification, including this one misalignment that affected more than half of surveyed respondents.

  8. Navigating FDA's New AI Systems: Practical Tips For Regulatory Success 1/19/2026

    AI-assisted reviews are changing FDA submissions. In part two of this series, discover how sponsors can address and even preempt regulatory and legal concerns.

  9. AI At The FDA: Legal Implications And Strategic Considerations For Drug Developers 1/19/2026

    AI-assisted reviews are changing FDA submissions. In part one of this two-part series, familiarize yourself with the FDA's use of AI and key legal concerns it raises.

  10. Virtual Reality Endpoints Improve Measurement Of Patients' Real-World Benefit 1/12/2026

    Opus Genetics CEO George Magrath, MD, discusses how the company introduced virtual reality-enabled assessments and relied on digital endpoints to better measure participants’ vision changes.