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| Gottlieb Warns Leaner FDA Will Challenge ClinOps | From The Editor | By Dan Schell, chief editor, Clinical Leader | Former FDA commissioner Scott Gottlieb told DPHARM attendees the agency is strained by staff losses and slowing policy work—leaving ClinOps teams facing tougher reviews, longer waits, and more uncertainty ahead. |
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| The Regulatory Binder Checklist For Clinical Trial Sites | Article | By Meghan Hosely, Advarra | By following this checklist, research teams can enhance organizational efficiency, maintain compliance with regulatory standards, and confidently navigate the complexities of documentation management. |
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| A Biologic Drug's Analytical Journey | Webinar | SGS | Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more. |
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| Integrating Early Development With Clinical Supply | Webinar | Catalent | In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes. |
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CHOOSE YOUR OWN ADVENTURE |
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| You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. 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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