Until now, most tasks required to start enrolling patients could largely be planned and managed independently, with minimal coordination between study, country and site project managers. The focus has been on the first activities required (e.g., first country and site approved), knowing additional activities will follow. This has allowed decentralized, unsophisticated planning and management, with only oversight responsibilities for global and EMEA project managers.
EU 536/2014 represents a paradigm shift to last country and site ready, with any missing content required for the study, country, or site approval delaying all countries and sites. These omissions can impact the overall study timelines by months.
As of January 2023, EU 536/2014 requires all new studies to be submitted under the Clinical Trial Regulation and to use the Clinical Trials Information System (CTIS) for submissions — which means that all countries and sites needed for large multi-country studies must be identified prior to July 2022. Project planning and management roles and systems must be implemented, or large multi-country studies run a significant risk of incurring months of delay.
Join this webinar to explore:
- Why EU 536/2014 will require coordinated, detailed global and EMEA planning and management.
- What are the most critical business roles to ensure study success with EU 536/2014 Clinical Trial Regulation?
- Which study activities and content are most likely to be on the critical path for EU submissions?
- How to use machine learning to do accurate submission prediction.
- How to ensure ongoing progress to identify critical process bottlenecks