Halloran Insights

31. Reconsidering The 3+3 Dose Escalation In Oncology Studies 2/16/2024

    Learn why incorporating alternative study designs to efficiently determine a safe and optimal RP2D is paramount for clinical research in 2024 and beyond.

32. Implications Of FDA's Final Guidance On Informed Consent 1/19/2024

    Watch this presentation for actionable insights to enhance the clarity, simplicity, and transparency of informed consent forms, ultimately improving participant experience and understanding.

33. Harnessing Clinical Data With An Integrated Infrastructure 12/19/2023

    Discover why it’s never too early to start integrating clinical data sources regardless of company size and how to get buy-in across the organization on the process.

34. 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.

35. 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.

36. '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.

37. 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.

38. 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.

39. 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.

40. 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.