EU CTR Submissions - Overview
On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU until the Regulation entered into application. Under this new regulation, clinical trial sponsors must submit all new clinical trial applications (CTAs) in the Clinical Trials Information System (CTIS) from 31 January 2023. National EU Member States and EU/EEA regulators also use CTIS.
Additionally, the following pointers highlight some of the key timelines for EU CTR adoption and readiness for its relevant stakeholders.
- All ongoing clinical trials in the EU must be transitioned to the CTIS by 30 January 2025.
- The revised CTIS transparency rules become applicable on 18 June 2024. Detailed information is available at EMA Webpage Guidance and Q&As - EMA (euclinicaltrials.eu)
- With these new regulations, Sponsors must consider the time necessary to complete the Member State procedure, which can take up to 3 months. Therefore, EMA advises sponsors to submit the applications well in advance of the end of the transition period on 30 January 2025.
These timelines underline the importance of having a Regulatory Partner who can swiftly manage and abide the dates and uphold submissions compliance.
Services
Our services are designed to cater end-to-end services for Clinical Trial Information Systems (CTIS). Our services include the following:
- Design of Interventional Clinical Study Protocol, which is required to follow European Union (EU) Clinical Trial Regulation (CTR) No 536/2014
- Centralization of clinical trials via CTIS, which requires support right from the Clinical Trial Application (CTA) to the submission of the Clinical Study Report (CSR)
- Data Transparency Services from the start of the trial registration to the marketing application phase
- Support for developing SOPs and guidelines specific to CTIS on a need basis
- EU-CTR/ CTIS Quality assurance
Expert Team
Freyr's EU CTR Regulatory Team has extensive knowledge of emerging regulations and processes for EU CTR implementation and submission.
Our team of thirty (30) EU CTR Regulatory experts including managers and associates with proficient experience in clinical trials supports our stakeholders, and sponsors for EU CTR implementation.
EU CTR Submissions
- Develops the operational implementation plan for CTAs in all regions from initial submission throughout the lifecycle, in alignment with the global submission strategy. This may concern trials across a variety of Therapeutic Areas, including oncology, gastrointestinal and inflammation, marketed products, and neuroscience.
- Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally and in Europe through the EU CTIS or legacy processes in conformity with legal requirements.
- Ensures oversight and tracking of CTA activities and electronic Trial Master File (eTMF) updates in collaboration with other teams to achieve compliance.
Freyr understands the requirements of the sponsors for EU CTR and provides customized solutions and support to meet the submission timelines. Freyr has a well-defined strategy to approach the EU-CTR submissions.
- Initial Consultation - We understand your requirements, assess your current processes, and identify gaps with respect to compliance with the new regulations of EU CTR.
- Strategic Planning - We develop a tailor-made plan suitable to meet your requirements and aid in providing a seamless transition per EU CTR requirements.
- Execution and Support - We could support you with end-to-end activities including preparation of protocol and Informed Consent Form per EU CTR submission requirements, actual submissions, preparation and submission of CSRs, submission of safety data from ongoing clinical studies
- Continuous Support - We help you to navigate the complexities of EU CTR, which would minimize the risk of non-compliance and ensure smooth operations.
- Optimized Resources - By letting us handle your EU CTR submissions, your resources could focus on your key business aspects of Innovation and Drug Development.
Why choose us as your EU CTR Submission guide?
The dedicated CTIS Expert team has in-depth knowledge of the CTIS platform and European regulations that help to provide cost-effective solutions to sponsors ensuring timely submissions.
