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Discover how to apply ICH E6 R3 in practice during this expert-led discussion on risk-proportionate approaches in clinical trials. Learn how to integrate and analyze data to streamline oversight, enhance compliance, and improve patient safety. Registration for this Clinical Leader Live digital event is free thanks to the support of Revvity, Medable, and PPD Clinical Research Business of Thermo Fisher Scientific.
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Decentralized Clinical Trials: Embracing The FDA's 2024 Final Guidance
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Guest Column | By Balaji Maddiboyina, Freyr Solutions
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In Sept. 2024, the FDA unveiled a final guidance aimed at advancing decentralized clinical trials. This article shares a summary, describes the differences from the 2023 draft guidance, and provides helpful insight for sponsors.
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Decentralized Solutions: Expanding Clinical Trial Access
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Article | By Leslie Carney, Elligo Health Research
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The clinical research landscape is increasingly adopting decentralized clinical trials (DCTs) and hybrid designs to enhance patient accessibility, inclusivity, and diversity.
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Flexibility In Phase 1 Study Timing
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Article | Altasciences
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Combining certain Phase 2 studies with the Phase 1 protocol gives you earlier access to data, which enables more informed go/no-go decisions early in the program.
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Organizational Assessment For A Large MedTech Company
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Case Study | Halloran Consulting
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Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.
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CHOOSE YOUR OWN ADVENTURE
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You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. To make changes to your newsletter selections, update your topic preferences.
- Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
- Clinical Trial Technology (Tuesday)
- Decentralized Trials | Trial Management (Wednesday)
- Outsourcing Models | Regulatory & Compliance (Thursday)
- Clinical Data Management & Analytics | Trial Monitoring (Friday)
Learn more about our personalized newsletters here.
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