Halloran Insights
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Preparing Now For FDA's START Program For Rare Disease Drug Developers
3/14/2024
Delve into this overview of the START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.
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Bringing In Vitro Diagnostics To Market With Real-World Evidence
3/14/2024
Explore the potential of real-world evidence in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.
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5 Broad Implications For FDA's Project Optimus
3/1/2024
While formal guidance on the reform the dose optimization and dose selection is still pending, review five common themes that could help sponsors prepare for these changes.
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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.
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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.
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Pulling The Thread On FDA's Master Protocol Draft Guidance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Review this analysis of the draft guidance and its potential implications, as well as recommendations for companies planning to use master protocols in their clinical trials.
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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.
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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.
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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.
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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.