The EUCROF Code of Conduct has been approved!
European CRO Federation (EUCROF) The European CRO Federation (EUCROF) announces that after the European Data Protection Board (EDPB) adopted the opinion 12/2024 on June 18th and the CNIL1 adopted resolution no.2024-064, the EUCROF Code for service providers in clinical research is now approved. On June 18th, the European Data Protection Board (EDPB) adopted the opinion […]
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CDISC Presents: TMF Reference Model General Meeting – Webinar
17 September 2024 – 11am – 12:30pm EDT Register for this webinar to receive essential updates on the CDISC transition and learn about new regulations and initiatives impacting Trial Master Files (TMF). Don’t miss this opportunity to stay informed about the latest industry standards and practices. Read more and register: https://cdisc.zoom.us/webinar/register/WN_WqNz9_hiRVihH_pe1IEurA#/registration
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Enabling Clinical Trial Innovation Through AI Regulation at FDA
Med City News Innovation is not just a luxury but a necessity in the realm of clinical trials, particularly as we strive to accelerate drug development. Yet, the slow pace of innovation within the U.S. clinical trials system has impeded progress, leaving many stakeholders frustrated. U.S. Food and Drug Administration (FDA) resource limitations cause the […]
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A Holistic Approach to Safeguard Data Integrity in Biopharma Manufacturing
International Biopharma Data integrity is critical in Biopharma manufacturing yet is often difficult to achieve due to complex regulatory requirements and legacy data management systems, among the many factors. Furthermore, issues such as data accuracy, completeness and security impact product quality, regulatory compliance and ultimately patient safety. Addressing all these challenges demands a multifaceted approach […]
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