Halloran Insights

31. The Value Of Artificial Intelligence To Support Inspection Readiness 3/1/2024

    Review three common inspection findings for overseeing all data and processes and ways that Artificial Intelligence can be integrated into an inspection readiness strategy.

32. Diversity In Clinical Trials: Shifting To Innovation Opportunities 3/1/2024

    Get an overview of the evolving landscape of clinical trials, where diversity and inclusivity are increasingly recognized as vital components of effective and comprehensive healthcare research.

33. Pulling The Thread On FDA's Master Protocol Draft Guidance 3/1/2024

    Review this analysis of the draft guidance and its potential implications, as well as recommendations for companies planning to use master protocols in their clinical trials.

34. 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.

35. 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.

36. 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.

37. 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.

38. 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.

39. '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.

40. 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.