Industry Insights

31. 5 Questions Every Sponsor Must Ask Before Selecting An eTMF Platform 3/12/2026

    Lean teams need a strategic eTMF choice. The right platform speeds startup, cuts manual oversight, strengthens site collaboration, and keeps studies inspection‑ready as portfolios grow.

32. Redefining Site Feasibility 3/12/2026

    Site feasibility is becoming a major source of startup delays as early requests, pre‑award outreach, and unclear communication create inaccurate projections and wasted effort.

33. Optimizing Clinical Trials In China With Strategic Solutions For Supply Chain 3/12/2026

    Plan proactively for clinical trials in China by aligning with National Medical Products Administration requirements and leveraging Free Trade Zones to streamline regulatory approvals and clinical supply importation.

34. Advantages Of Sourcing Biosimilars Vs. Branded Biologics In Clinical Trials 3/12/2026

    Evaluate biosimilar alternatives during clinical trial planning to reduce comparator drug costs and improve overall study efficiency without compromising trial integrity.

35. FDA's Elsa AI Switches From Claude To Gemini: What Sponsors Need To Know 3/12/2026

    Forced to cease using Anthropic's Claude for its Elsa generative AI assistant, the FDA is switching to Gemini. Legal experts Kimberly Chew, Esq., and Michael Yang, Esq., explain the implications for trade secrets and data security risks.

36. How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment 3/12/2026

    The relationship between the Affordable Care Act (ACA) enhanced premium subsidies and clinical research isn’t widely understood, so consultant Devra Densmore is clearing things up, including how coverage loss could impact trial enrollment.

37. Patient-Powered Drug Trials Are Getting The FDA Greenlight 3/12/2026

    Patient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.

38. Clinical Development And Supply: Breaking Down Early Small Molecule Development 3/11/2026

    Adopt an integrated development strategy to streamline the path from early development to the clinic, ensuring timely clinical supply while reducing delays, risk, and inefficiencies.

39. How AI Supports Data Recording And Quality 3/11/2026

    AI speeds early‑phase development by streamlining data review, enabling structured queries, accelerating PK/PD work, and revealing biomarker patterns — boosting efficiency with expert oversight.

40. When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down 3/11/2026

    Regulators want one thing during inspections — to see how the data flows, says Just In Time GCP's Donna Dorozinsky. Here, she explores the importance of data oversight and where sponsors sometimes go wrong.