Newsletter | April 25, 2024

04.25.24 -- Reflection And Advancement: J&J's Global Immunology Leader

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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.

OUTSOURCING MODELS

Reflection And Advancement: J&J's Global Immunology Leader

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.

Outsourcing Vendor Red Flags: Bids And Contracts

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.

Weighing FSP Model Suitability For Clinical Trials

Consider several key points outlined in this article when deciding if a functional service approach could better serve a clinical team and its drug development study.

The Importance Of An Implementation Lead Within FSP Models

Uncover how the role of the Implementation Lead from PPD™ FSP ensures streamlined and expertly managed onboarding and resource allocation for FSP clinical research projects.

Outsourcing High Potent OSD Late-Stage Development: CDMO Insights

View the webinar to discover outsourcing options for highly potent oral solid dose therapies, and learn how CDMOs can transfer, handle, and deliver their product to clinic and to market.

REGULATORY & COMPLIANCE

FDA Warns Of Fraudulent, Unreliable Lab Data In Premarket Submissions

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.

Bridging The Gap: Breaking APAC Into The U.S. FDA Market

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.

Adopt Tech Solutions To Innovate And Streamline Regulatory Services

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.

GxP Best Practices For Safer, Smarter, Faster Clinical Research

Delve into fundamental GxP principles, essential regulatory aspects, and underscores the critical role GxP plays in ensuring the achievement of prosperous and ethical clinical trials.

EU Annex 11: How To Stay Compliant

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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  • 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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