Impact of the In Vitro Diagnostic Regulation on Clinical Trials in the EU and CRO Outsourcing Report

Menlo Park, CA, January 17, 2024 --(PR.com)-- Life Science Strategy Group (LSSG), the leading strategic consulting firm to the CRO, CDMO and biopharmaceutical services industries, is pleased to announce the launch of its new syndicated report, Impact of the In Vitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing. The research report includes insights from 90 biopharmaceutical participants in the US and EU and explores the impact of IVDR delays on site selection and clinical trial CRO partnerships, with detailed findings on potential strategies and/or shifts to be implemented by biopharmaceutical companies to mitigate delays caused by the IVDR.

This landmark study explores delays in EU/EEA countries due to IVD and PSA and the likelihood of sponsors to take actions given trial delays, impact of continued IVDR delays on clinical trials, preferences for trials shifted from EU/EEA countries, potential CRO Strategies for alternative trial sites and CRO regulatory landscape leaders.

“While the In Vitro Diagnostics Regulation (IVDR) in the European Union and the European Economic Area (EU/EEA) was established for the 'right reasons,' it seems the requirements may have been passed without fully acknowledging the lack of standardization in the PSA process across EU countries and the impact it would have on clinical trials,” said Jon Meyer, Managing Member, Life Science Strategy Group. “Our report is a game-changer for the industry, providing valuable insights that trial sponsors and CROs including IQVIA, ICON, PPD/Thermo Fisher Scientific, Fortrea, Parexel and Syneos Health can utilize to make informed decisions. With the potential for the IVDR/PSA requirement to cause disruptive delays in EU/EEA countries, the shift towards alternative trial sites and the reliance on the right CRO partners has never been more critical.”

To learn more or to download report sample pages, visit www.lifesciencestrategy.com/publications.

About Life Science Strategy Group, LLC
Life Science Strategy Group, LLC is a consultancy specializing in strategic consulting, market research engagements and syndicated publications across a variety of therapeutic, technology and service industries including contract research services, pharmaceutical, biotechnology, medical devices, diagnostics, and drug discovery.