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| In this segment from Clinical Leader's Solutions Expo: EDC Showcase, experts Paul Sahargun and Neil Vivian of Anju Software delve into the crucial role of EDC in fostering diversity within clinical trials. Watch the full presentation for insights into modern clinical workflows, leveraging comprehensive data, improving population health, and ensuring patient-centered approaches. |
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| Reflection And Advancement: J&J's Global Immunology Leader | Guest Column | A conversation with David Gordon, Johnson & Johnson Innovative Medicine | In this Q&A, David Gordon, M.B., Ch.B. recounts lessons learned from past clinical trial challenges and shares current-day strategies, like figuring out how to run a study that’s both scientifically sound and actually doable for patients and doctors. |
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| Outsourcing Vendor Red Flags: Bids And Contracts | Article | inSeption Group | Adept CRO communication doesn’t just indicate the vendor’s ability to deliver a thoughtful bid; it demonstrates their ability to analyze, operationalize, and optimize a plan. |
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| FDA Warns Of Fraudulent, Unreliable Lab Data In Premarket Submissions | Guest Column | By Erika L. Roberts, ELR Lab Services LLC | The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do. |
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| Bridging The Gap: Breaking APAC Into The U.S. FDA Market | Guest Article | By Jonathan Helfgott and Mathew Thomas, Ph.D., Healthcare Innovation Catalysts, Biorasi | For APAC companies, it's important to identify the differences in care standards, formulate strategies for compliance, and develop solutions to bridge the regulatory gap and realize FDA approval. |
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| Adopt Tech Solutions To Innovate And Streamline Regulatory Services | White Paper | By Michelle Gyzen and Jens-Olaf Vanggaard, IQVIA Safety & Regulatory Compliance | See how transformative technologies like AI and ML augment the regulatory professional workload to ensure compliance, patient accessibility, and rapid timelines for approval for global drug campaigns. |
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| EU Annex 11: How To Stay Compliant | Article | By Taylor Davidson, Florence Healthcare | EU Annex 11 lays out the European Union’s regulations for using computerized systems during clinical trials. Learn how sponsors and sites seeking treatment approval in the EU must follow Annex 11. |
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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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