Regulatory Insights
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Handling Substantial Modifications Under The CTR
3/15/2024
The transition of ongoing clinical trials to meet CTR requirements can be challenging. Examine some key considerations, including substantial modification processes and strategic dossier updates.
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FDA Continues Diversity Push
3/15/2024
Review the FDA's revised 2016 diversity guidance, which establishes clear expectations and standardizes recommendations for gathering and reporting race and ethnicity data.
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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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Key Insights From The FDA's DHT Guidance
3/12/2024
Check out a summary of the FDA’s guidance Framework for the Use of DHTs in Clinical Trials and what it means for sponsors and investigators using these innovative tools.
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PV Solutions Optimizing End-To-End Safety In Clinical Development
3/6/2024
Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.
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How Sponsors And Sites Work Together To Improve Protocol Compliance
3/5/2024
Learn about strategies aimed to reduce protocol deviations and enhance compliance and quality. By implementing such measures, clinical trial teams can streamline operations and minimize the risk of regulatory issues.
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How To Improve Your Site Compliance And Performance
3/5/2024
Delve into site and protocol violations to gain insights on how to assist sites in enhancing their compliance without adding undue burdens that could affect critical timelines.
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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 Write Side Of AI: Helping Hands, Not Replacement Plans
3/1/2024
AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.