Case Study: MediSpend accesses EMA Regulation (EU) 536/2014 resources with Real Life Sciences

MediSpend streamlines CTIS readiness with Real Life Sciences

MediSpend, a pharmaceutical company, needed to prepare its team for new clinical trial disclosure requirements under EMA Regulation (EU) 536/2014 and the CTIS system. They turned to Real Life Sciences for guidance and resources to navigate this complex regulatory change.

Real Life Sciences provided MediSpend with a curated list of essential resources, including the official EMA Sponsor Handbook and practical training from the DIA. This solution equipped MediSpend's team with the knowledge for hands-on CTIS use, helped them plan roles and responsibilities, and ensured they understood the new disclosure deferral rules.

MediSpend