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| FDA’s MRCT Guidance Is Here. Are You Ready? | Geography once stood in for diversity — but genetics, standards of care, and epidemiology don’t follow borders. FDA’s new MRCT guidance makes it clear: global data fails if it doesn’t apply to U.S. patients. This new whitepaper by Precision’s CMO and former FDA Oncology Division Director, Dr. Harpreet Singh, explains what regulators expect and how to position your program for approval. |
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| What Sponsors Get Wrong When Selecting A CRO | Article | Dash Bio | Gene therapy immunogenicity requires platforms, judgment, and regulatory fluency beyond ADA norms. Relying on biologics criteria creates gaps; CGT expertise ensures reliable, interpretable results. |
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| A New, AI-Augmented Horizon For Safety And Pharmacovigilance | White Paper | By Ian Fisher, Michelle Gyzen, Archana Hegde, et al, IQVIA Safety & Regulatory Compliance | Is your organization leveraging AI to maximize efficiency in safety and regulatory workflows? If not, explore how these technologies are slated to improve industry approaches in 2026. |
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| Drug Price Controls: The Unintended Consequences To Innovation | Video | ISPOR—The Professional Society for Health Economics and Outcomes Research | Review the ripple effects of drug price controls, including recent U.S. policy shifts like the IRA and President Trump’s Executive Order introducing International Reference Pricing. |
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| Build Systems That Scale With Every Stage Of Growth | Article | By Jim Ingram, Sikich | Learn how to synchronize finance and R&D with a scalable operational framework. Automate manual steps and strengthen compliance to ensure your infrastructure evolves as fast as your science. |
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| AI Meets Informed Consent: Opportunity, Risk, & What IRBs Need to See | As generative AI begins shaping how consent materials are created and delivered, sponsors and CROs face new ethical and regulatory challenges. This session explores core consent principles, emerging AI applications, and what IRBs need to know. Clinical operations leaders will gain a framework for evaluating AI assisted consent tools, improving IRB collaboration, and protecting participant understanding and autonomy. Click here to learn more. |
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| Clinical Safety Services In FSP Models | Article | By Lisa Dawson and Emily Anderson, Worldwide Flex | Selecting the right functional service provider (FSP) for safety services is fundamental to protecting patients and requires a resilient, strategic partnership that enhances trial integrity and outcomes. |
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| The Next Generation Of Oral Targeted Therapies | Brochure | PCI Pharma Services | Solve the unique challenges of poorly soluble molecules like targeted protein degraders, seamlessly accelerating your molecule from development to commercialization. |
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| Specialized Support For Clinical Supplies | Video | Catalent | Understand how specialized clinical supply roles — from project managers to 24/7 case managers for CGTs — work together to prevent delays and execute winning supply strategies for trials. |
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| Customized CRO Services For Every Study | Product | Altasciences | Altasciences offers custom clinical research solutions: site management, clinical trial monitoring, project management, biostatistics, regulatory guidance, clinical sample kit management, and more. |
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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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