GUEST COLUMNISTS

• 4 Factors Changing The Way CRAs Monitor Trials

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

• How Can AI Change Computerized System Validation?

  Learn how AI technologies are changing the computer system validation (CSV) landscape and what you need to understand about this transformation.

• Too Little Info, Too Much Time Wasted: Feasibility Challenges For Sites

  Incomplete protocols, lengthy sponsor decision timelines, and uncompensated work plague clinical research sites. Learn why these issues exist and how to address them alongside experts from SCRS and Tufts CSDD.

• Will New AI Health Assistants Suggest Clinical Trials To Inquiring Patients?

  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?

• What CROs Do Right Isn't Always Obvious To Research Sites

  CROs are doing many things right. But it's when that right thing is understood — not just executed — that the impact becomes far greater than compliance alone.

• How Gilead Includes Patients Most Affected By HIV In Its PrEP Trials

  VP of Clinical Development, HIV, Moupali Das shares how the sponsor approaches diverse participant recruitment and enrollment, highlighting the importance of early demographic research and careful, intentional PI selection.

• 3 Clinical Research Attorneys Talk 2026 Trends

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

• The "One-Trial" Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational Risk

  When it comes to the FDA's new "one-trial" shift, researcher Johnathon Anderson, Ph.D., warns: Do not confuse efficiency with leniency. Here, Anderson offers three factors to consider when adapting to new FDA trial expectations.