Halloran Insights

51. Prepare For ICH E6(R3) GCP When You're Still Struggling With (R2) 10/29/2023

    Get strategies to confidently navigate revisions to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline.

52. FDORA And The Diversity Action Plan Requirement – Are You Prepared? 10/29/2023

    The U.S. Congress recently acted to enhance diversity in clinical trials, necessitating clinical trial sponsors for most drug and device studies to submit a Diversity Action Plan. Revisit the path that brought the industry here.

53. The Criticality Of CMO Selection For Small Biopharma Companies 10/29/2023

    Delve into the criteria that small or early-stage biopharma companies should consider during their CMO selection process, along with key considerations to keep in mind.

54. How Strong Project Management Propels Clinical Development Success 10/29/2023

    According to JAMA, only one in five trials is completed on time. Examine how robust project management throughout the drug development lifecycle can yield significant time and cost savings.

55. Feedback On FDA's eSystems, Records, And Signatures Guidance 10/27/2023

    Review this collection of industry feedback received during the Clinical Operations Retreat for Executives where leaders discussed the FDA's latest draft guidance in an interactive workshop.

56. Establishing A Culture Of Quality: What Every CMO Should Know 10/23/2023

    Learn to adequately recognize the fundamental components of a quality-driven culture, unlock the means to foster such a culture, and grasp the advantages and consequences.

57. Site And Patient-Centric Approach To Clinical Trial Training 10/23/2023

    Review this collection of insights and practical takeaways that can be applied within organizations as they begin modernizing clinical trial design and operations.

58. FDA's Draft Guidance On Psychedelic Drugs Raises Questions 10/23/2023

    Explore how the U.S. Food and Drug Administration's draft guidance for industry on “Psychedelic Drugs: Considerations for Clinical Investigations" intends to support the ethical conduct of trials, uphold trial integrity, and ensure the reliability of trial results.

59. Risk-Based Approach To Monitoring Of Clinical Investigations 10/23/2023

    Delve into four key themes found within the FDA's recent guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry."

60. Raw Materials Control For Biotechs (Part 1) 10/23/2023

    Navigate challenges posed by raw material usage and learn how to lay a robust current Good Manufacturing Practices groundwork for a control program.