Prepare and submit Clinical Study Application (CTA) to secure timely study approval
Wherever you plan your clinical studies, we are able to provide you:
- Expert regulatory knowledge at the forefront of innovation and compliance
- Filing strategy and planning
- Identification and controls of regulatory requirements
- Development of application package (CTA, IND, etc.)
- Submission and correspondence with evaluating bodies, response to evaluation queries
- Coordination of subject matter experts
EU Clinical Trials Regulation
The new EU Clinical Trials Regulation (EU-CTR) (Reg. (EU) No. 536/2014) has been implemented on 31 January 2022 with the aim to simplify and harmonize procedures for the submission, assessment, and supervision of clinical trials across the EU Member States.
The EU-CTR allows sponsors to make a single clinical trial application (CTA) for all EU Member States where a given trial is intended to be conducted, via a centralized portal – the Clinical Trials Information System (CTIS).
This new process, while designed at encouraging the conduct of clinical studies across Europe will also represent a huge challenge for sponsors, particularly during the transition phase that will last until 31 January 2025.
VCLS has an in-house CTIS Sponsor Master Trainer, formed by the EMA. Our team’s first-hand knowledge of the CTR implementation and experience in working with the CTIS Sandbox makes us fully empowered to accompany you through the best implementation strategy of the EU-CTR.
Our tailor-made solutions for a seamless EU-CTR implementation include:
- EU-CTR training
- CTIS training and organizational/User management recommendations
- Strategic transition and transparency recommendations, specific to your overall clinical development plan and prepared by our EU-CTR experts
- Assessment of your CTR-Readiness: Gap Analysis
- Ongoing Regulatory Intelligence services
- CTA submission and maintenance (including safety reporting), with a customized level of outsourcing to meet your specific needs