INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission

  Learn how to create a direct line from clinical planning and protocol design to clinical trial disclosure to optimize efficiency across the entire trial lifecycle.

• Fast-Track Innovation, Address CMC Challenges In Expedited Pathways

  Learn to overcome solubility challenges and utilize flexible development strategies to transition innovative treatments from early-phase trials to commercialization while ensuring patient safety.

• Serbia: Europe's Emerging Clinical Trial Powerhouse

  Discover why Serbia is becoming a top strategic choice for sponsors, including details of the country's strengths in key therapeutic areas, streamlined processes, and operational advantages.

• We Made Five Predictions For Clinical Research Last Year. Here's What Happened

  Review 2025’s gap between AI discovery and trial execution, highlighting legislative and FDA shifts to help sponsors operationalize participant experience for 2026.

• What the FDA Looks For In Global Development Programs Today

  1/16/2026

  Mastering the complexities of multi-regional clinical trials requires aligning global data with evolving regulatory expectations to ensure treatment consistency and successful drug approval.

• The Value Of Patient-Reported Outcomes In Cancer Clinical Research

  1/16/2026

  Standardizing patient-reported outcomes and real-time monitoring transforms the patient voice into a powerful tool for regulatory success and superior clinical care.

• Clinical Development Crystal Ball: What To Watch In 2026

  1/16/2026

  Explore how AI integration, remote assessment, and precision measurement are reshaping clinical trials in 2026 to improve data quality and patient outcomes.

• Why Risk-Based Thinking Is Transforming Life Sciences Validation

  1/16/2026

  The FDA’s CSA framework replaces traditional CSV with a risk-based approach, reducing inefficiencies and enabling faster innovation. Learn why this shift matters for your organization.

• The Clinical Trial Rescue Triage Playbook

  1/15/2026

  Quickly assess clinical trial risks by evaluating site impact, patient safety, and budget tradeoffs. Turn high-pressure rescue scenarios into clear, actionable paths for your research team.

REGULATORY MULTIMEDIA

• Engage Early With The FDA On AI … Or Expect Problems

  You've heard it before; sponsors must engage FDA early when using AI in clinical development. Hilary Marston warns that late engagement can cause irreparable damage to your regulatory strategy.

• CRL Transparency Comes With Real Trade-Secret Risks

  Sure, increased transparency around Complete Response Letters sounds good, but Elizabeth Jungman warns that FDA’s new disclosure approach may expose sponsors’ confidential and commercially sensitive information.

• Can The FDA Easily Replace The Experience It Has Lost?

  Elizabeth Jungman describes how early retirement programs and workforce reductions led to the loss of highly experienced FDA leaders, creating gaps in institutional knowledge that affect complex regulatory decisions.

• We Can't Really Interpret R3 In A Vacuum

  Having problems interpreting ICH guidelines or deciding what to do next? Sophia McLeod offers some advice and resources, and then she also explains why she thinks it’s good that we’re living in this “show-your-work” kind of era.

• FDA Talent Loss Is Real — And It's Not Evenly Distributed

  Hilary Marston discusses how staffing losses at FDA are uneven across divisions, with particularly heavy impact in innovative areas like AI and real-world evidence.

• Policy by Press Release Is Now a Real Problem

  Sophia McLeod, advocacy advisor, at ACRO, explains what ACRO members are concerned about regarding the FDA staffing losses. She also talks about the effects of "policy by press release" rather than traditional notice-and-comment periods.

• Fast-Track Innovation, Address CMC Challenges In Expedited Pathways

  Learn to overcome solubility challenges and utilize flexible development strategies to transition innovative treatments from early-phase trials to commercialization while ensuring patient safety.

• 3 FDA Approvals In 2025 That Shift The Landscape For 2026

  In this presentation, Precision’s Chief Medical Officer and former FDA Director, Division of Oncology 2, Harpreet Singh, MD breaks down 3 FDA approvals from last year that are impacting 2026.

• The FDA Year In Review — And What Comes Next

  The FDA didn’t sit still in 2025, and neither can you. Our industry insider panelists, Sophia McLeod, Elizabeth Jungman, and Hilary Marston, M.D., M.P.H. cut through the noise to explain which regulatory shifts, guidance updates, and inspection trends really matter for clinical trials in 2026 — and what you should do about them.

• Should Sponsors Provide Source Document Templates?

  Here, we debate sponsor-provided source document templates, weighing regulatory guidance, compliance risks, and operational impacts for smarter clinical trial documentation decisions.