Halloran Insights

31. Navigating Change Management In Technology Implementation 12/19/2023

    Access this collection of actionable strategies to optimize technology and systems with a strong emphasis on change management and alignment with regulatory requirements.

32. Operational Disruption: Assuring Clinical Data Integrity 12/19/2023

    Explore three essential insights for effective protocol preparation and managing disruptions mid-stream to safeguard the integrity of clinical data.

33. 'Good Science' For Systematic Literature Reviews 10/29/2023

    Assess the effectiveness of commonly employed strategies for selecting publications to include in a literature review and how to offer guidance on best practices for evaluating publications and their data.

34. Advanced Therapy Medicinal Products: Recent US Approvals, Upcoming Guidance 10/29/2023

    Explore the 2022-2023 approvals of ATMPs by the Center for Biologics Evaluation and Review and the newly named Office of Therapeutic Products.

35. Cell And Gene Therapy Development – 3 Key Challenges In 2023 10/29/2023

    Considering the current landscape, here are three critical factors for cell and gene therapy developers to overcome obstacles and advance development.

36. Reimagining Clinical Studies To Support Anticancer Products 10/29/2023

    Understand why more frequent surveillance and a reevaluation of the clinical studies are required to support Accelerated Approval for anticancer products.

37. Psychedelics As Therapeutics – What Developers Need To Know 10/29/2023

    Drug developers and others intrigued by the dynamic and promising field of psychedelics as therapeutics can gain valuable guidance from a recap of the 3rd annual Psychedelic Therapeutic and Drug Development Conference.

38. Best Practices For Designing Patient-Centric Decentralized Clinical Trials 10/29/2023

    Gain a comprehensive understanding of decentralized trials, hybrid trials, and agile trials, and why it's essential to pause, allocate more time for gathering crucial patient feedback, and incorporate it into the planning process.

39. 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.

40. 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.