GUEST COLUMNISTS

• Could Study Rehearsals Create A New Standard For Site Readiness?

  Giving sites the chance to rehearse a trial ahead of their initial study visits could lead to improved readiness, protocol adherence, and participant experience.

• The Much-Feared FDA Form 483, Part 2

  Dr. Robert Califf argues that FDA Form 483, while useful for identifying issues in clinical research, is often applied punitively, causing reputational harm and unnecessary complexity. He advocates for a contextual, quality‑focused approach supported by AI and modernized guidelines to improve evidence generation efficiently.

• Opus Genetics Shows Proper Planning Is Key To Adaptive Trial Design

  Opus Genetics CEO George Magrath, MD, shares the team’s experience with an adaptive Phase 1/2 trial design for an ocular gene therapy.

• Building A Future-Proof, GxP-Compliant IT Infrastructure

  Learn how a structured IT evaluation framework can help companies model total compliance costs, request vendor qualification evidence, and embed governance requirements into infrastructure selection.

• The Much-Feared FDA Form 483

  Dr. Robert Califf explains that FDA Form 483 is often misunderstood as a final judgment, when it is actually an initial notice of potential issues found during inspections. He argues the form should be seen as a tool for quality improvement, not a proxy for overall performance, and he calls for more efficient processes to reduce unnecessary anxiety and delays.

• Unlocking Biopharma Innovation With Real-World Evidence

  Discover how how federated data networks, platform aggregators, and collaborative partnerships have evolved to meet the data demands of modern product development, regulatory strategy, and commercial success.

• Bayesian Digital Twins Show Potential For Predicting Prognosis And Treatment Response

  Learn how Bayesian digital twins are trained, validated, and trusted in clinical settings and explore the potential for integrating these models into interventional trials.

• Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing

  Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.