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| Join Clinical Leader on October 23 at 1PM ET for a virtual panel discussion on FSO or FSP? What Works, When, and Why. Registration is free with support from Catalyst Flex. |
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| How Strategic LQPPV Outsourcing Future-Proofs PV Compliance | Article | By Ana Pedro Jesuíno, Dominique Coleman, and Barry Mulchrone, IQVIA Safety & Regulatory Compliance | As health authorities seek standardization across global processes and strong AI governance, working with an experienced PV partner will help minimize the burden of oversight and ensure compliance. |
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| Delivering Specialist Neurology Support | Case Study | MRN - Medical Research Network | Review a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support. |
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| Considerations When Outsourcing Your Packaging Operations | Q&A | By Yves Massicotte, Ropack Pharma Solutions | Explore the key to maintaining and enhancing existing and new partnerships as well as how outsourcing one crucial aspect of bringing products to market can benefit overall supply chain optimization. |
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| A CRO Accelerating Bioanalysis | Brochure | Dash Bio | Move drug development into the modern era with a CRO that offers assay development and validation, bioanalytical testing, sample prep, and more. |
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| Proven Expertise With Global Solutions For U.S. Biotechs | Product | Avance Clinical | The success of a biotech drug development program often depends on the relationship it forms with its CRO partner. Avance Clinical has a track record with over 200 U.S. studies including 140 in oncology. |
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| Webinar: How to Select the Right Bioanalysis CRO for your Program | For a biotech company, selecting the right bioanalysis CRO partner can make or break their program timeline. Bottom line: the right bioanalysis CRO becomes a true accelerator; the wrong one slows you down. Join us for an unfiltered examination of bioanalysis CRO selection challenges, red flags to avoid and solutions for securing a bioanalysis partner that matches your program's pace. Register Now. |
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| Post-Trial Access: Compliance Lessons Hidden In Plain Sight | Guest Column | By Edye T. Edens, JD, MA, CIP, CCRP, EEDEE Law | What happens when the trial ends and the investigational product is no longer available? Edye T. Edens, JD, MA, CIP, CCRP, talks through the answer. |
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| How AI And Biomarkers Are Reshaping Drug Development | Article | By Rob Maiale, Precision for Medicine | Learn more about the importance of biomarker-driven drug development and the integration of laboratory science, clinical expertise, and regulatory strategy to accelerate targeted therapy development. |
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| Regulatory Strategy And Submission Support | Brochure | Novotech | Our team designs customized nonclinical development strategies that align with global regulatory requirements, ensuring efficient clinical trial readiness and market entry. |
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| IRB Solutions To Empower Better Research Programs | Brochure | Advarra | Irrespective of a project's scale, therapeutic focus, or the size of its investigative team, discover how Advarra works to stand as a trusted partner in conducting efficient and responsible research. |
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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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