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| Webinar: Ensuring Compliance in Gene Therapy Trials for Neurological Disorders: IRB and IBC Perspectives | Gene therapy research for neurologic disorders presents distinct ethical, regulatory, and biosafety challenges, particularly with vulnerable populations. In this BRANY webinar, IRB and IBC experts, along with a medical ethicist and neurologist, share insights on nuanced consent, caregiver considerations, and oversight. Sponsors, CROs, investigators, and review boards will gain guidance to navigate these complex trials. Click here to learn more. |
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| Managing Risk And Regulation In Clinical Trial Technology | Article | By Priyanka Sharma, Suvoda | Now is the time to evaluate your current risk management framework. Take action today to strengthen your safeguards, tailor your risk assessments, and prioritize transparent patient engagement. |
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| Five Ways To Get Ready For IRT Regulatory Inspections | Article | By Justine Koor, IQVIA Technologies | Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help. |
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| Join our expert panel on Clinical Leader Live on September 26 at 1pm ET as we explore the urgent need for diversity in clinical trials amid political headwinds and policy rollbacks. We’ll unpack recent setbacks, examine their real-world impact, and discuss why equitable patient recruitment must remain a top priority. Don’t miss this timely conversation on safeguarding inclusion in medical research. Registration is free. Reserve your spot today. |
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| How To Build Partnerships For Sustainable Healthcare | Article | By Helga van Kampen, Lola Gostelow, Partnership Brokers Assocation and Ania Mitan, DIA | Effective partnerships are essential to address the multifaceted challenges of the healthcare sector, yet collaborative efforts often face persistent barriers. |
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| A Streamlined Approach To 14C Human ADME Studies | Article | Quotient Sciences | Understand the benefits of a program that allows for a flexible approach to human ADME studies and the breadth of supporting data and case studies that demonstrate both significant time and cost savings. |
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| PCI Pharma Services Capacity Update July 2025: Fill/Finish | Video | PCI Pharma Services | PCI is positioned to meet the future of sterile pharmaceutical development and manufacturing with cutting-edge technology, and innovative solutions for high-value biologics, complex formulations, and lyophilized drug products. |
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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)
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