Regulatory Affairs Editorial

31. How Laboratory Manuals Fail Sites And Sponsors 12/19/2024

    In part one of this series, FlexPoint Bio Founder and CEO Elena Sinclair describes the hazards of poorly designed (and followed) clinical trial lab manuals.

32. Were There Any Surprises In Clinical Trials In 2024? 12/4/2024

    Is it any surprise that when I asked a group of clinical trial industry experts to summarize some of the things that stood out to them in 2024, that AI would be mentioned more than once? Probably not. Resistance to DCTs, increasing regulatory scrutiny, and a slowdown in CRO M&As also made their lists — but I’m guessing none of that surprises you, either.

33. Can Better Data Management Save Clinical Trials? 11/25/2024

    In this summary of our 10/31/24 Clinical Leader Live, we talk about the current ICH M11 guideline, which focuses on a clinical electronic harmonized protocol, as well as the need for data standardization and the benefits of the resulting automation. Our panelists include Jessica Jolly, a data science expert with 25 years of experience, and Hassan Kahlid, senior engineer, machine learning and data science at AstraZeneca.

34. How Changes To The Declaration Of Helsinki Impact Clinical Trials 11/18/2024

    Consultant Jessica Cordes breaks down the latest version of the Declaration of Helsinki and how it builds upon the previous version from 2013.

35. PI Insights From A Heart Failure Trial: Part 1 11/14/2024

    Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial, talks about her role as a PI including trial design and meetings with the FDA.

36. FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission 10/18/2024

    The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.

37. The Regulatory Affairs Function Is Evolving. Are You Evolving With It? 10/10/2024

    The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

38. How One Biotech Is Using FDA 505(b)(2) To Get Drugs To Patients Quicker And Cheaper 10/9/2024

    Terran Biosciences CEO Sam Clark, MD, Ph.D. explains how his team is leveraging the 505(b)(2) regulatory pathway to get its new schizophrenia drug to patients quickly and affordably. 

39. An Expert Guide To Effective Sponsor Oversight In Clinical Trials 10/8/2024

    Consultant Jessica Cordes explains how combining thorough sponsor oversight with robust risk management practices, sponsors can significantly enhance the quality and reliability of clinical trials. 

40. The Crucial Role Of Sponsor Oversight In ICH E6 (R3) 10/7/2024

    ADRES Bio leaders Inbal Hacmon and Rivka Zaibel delve into the critical aspects of ICH E6 (R3), shedding light on its implications for clinical trial sponsor responsibilities.