Regulatory Insights
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Early Collaboration With FDA For Novel Programs: Maximizing ETP
10/23/2023
Get an overview of the U.S. Food and Drug Administration’s collaborative Emerging Technology Program within the Center for Drug Evaluation and Research, enrollment criteria, and benefits.
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The Easiest Way To Meet the FDA’s Clinical Trial Diversity Requirement
10/20/2023
Explore how this innovative approach to navigating FDORA streamlines the diversity action plan process while placing a strong emphasis on patient-centricity.
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Best Practices For Quality, Compliant Clinical Trials
10/20/2023
It’s simple: Quality research is nonnegotiable. Gain insights into how teams can ensure all aspects of their trial are high quality, will withstand scrutiny, and protect the patient.
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For Clinical Trial Disclosure, There’s No Comparison
10/19/2023
Learn how TrialScope Intelligence centralizes all the regulatory knowledge needed in a user-friendly format, giving sponsors the information they need to compare clinical trial disclosure regulations in seconds.
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Clinical Trial Disclosure Compliance: A Moving Target
10/19/2023
To date this year, 115 updates to clinical trial disclosure rules have been tracked across global regulatory agencies. See what types of changes have occurred, where they were, and how they are implemented.
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Navigating CAPA: Ensuring Compliance And Quality Assurance
10/18/2023
For clinical development entities, see how a well-executed CAPA system can function as a guide and steer the course toward continual enhancement while upholding regulatory adherence.
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What Is A Data Monitoring Committee?
10/18/2023
Look at the specific role DMCs play in overseeing research, and how IRBs rely on the independent DMC’s oversight of interim trial data to ensure an adequate safety monitoring plan is in place.
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Empowering Freenome: Large-Scale Data Quality And Compliance
10/17/2023
Delve into the five key ways this biotech company was able to successfully deliver data quality and compliance for large-scale trials while developing next-generation blood tests for early cancer detection.
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Overcoming Financial Toxicity In Oncology Clinical Trials
10/12/2023
Review the historical struggles of oncology research due to financial toxicity, what industry initiatives are breaking barriers, and ongoing D.C. advocacy for lower patient stipend taxes.
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Regulatory CMC Considerations For Biotherapeutics And Cell And Gene
10/10/2023
Follow along as Regulatory CMC from Veristat covers critical topics related to CMC regulations, addressing key challenges, outlining effective strategies, and highlighting important considerations for analytical programs.