EMA & the Clinical Trial Regulation
Is your organization ready for the new Clinical Trial Regulation in the EU?
Currently, a European Clinical Trial must be conducted in accordance with the Clinical Trials Directive (CTD). In the coming years, the European Medicines Agency (EMA) will implement the Clinical Trial Regulation (CTR), thereby replacing the CTD. The aim is to harmonize the conduct of clinical trials in the EU by streamlining submissions and approvals, improving the assessment process and overall transparency.
With the CTR, a new submission portal is planned to be implemented supporting a centralized way to electronically apply for new clinical trials in the EU.
The CTR will put pressure on organizations to align with stricter timelines for the submission of a Clinical Trial Application (CTA). The question now stands – Is your organization actualizing the potential associated benefits from the implementation of CTR?
HERAX has experience from multiple projects in this area and can support your organization with:
- Harmonizing global and country-specific document creation and assembly processes.
- Assessing and implementing solutions to support a centralized CTA process