Set up
At CHDR, our regulatory department manages the entire regulatory process for your study, including preparing and submitting the Clinical Trial Application (CTA). We provide comprehensive support throughout the submission process, ensuring all required documents are accurately prepared and delivered well in advance of the submission deadline. We also have extensive experience with non-standard submissions and offer consultation on regulatory matters related to medical devices or non-interventional medicinal products, ensuring full compliance with EU regulations.
All trials within the scope of the Clinical Trials Regulation (CTR) are submitted via the Clinical Trials Information System (CTIS), the EU’s central portal. The CTA undergoes validation by the competent authority (CCMO) before being assessed by an accredited ethics committee. Throughout this process, CHDR maintains close communication with the relevant national regulatory authorities. With a strong, established relationship with the ethics committee, we streamline the approval process, ensuring that regulatory approval is typically obtained within six weeks of submitting the CTA.
Regulatory Compliance Support for Non-EU Sponsors
The CTR requires non-EU sponsors to appoint a Legal Representative within the EU to ensure compliance with the regulation. CHDR can act as the Legal Representative for sponsors if needed. Additionally, non-EU sponsors must designate an EU-based General Data Protection Regulation (GDPR) representative and a responsible person for pharmacovigilance (PV) requirements. While CHDR cannot serve as the GDPR representative or PV responsible person, we can recommend trusted partners who offer these services.
Conduct
Our Clinical Trial Assistants (CTAs) play a crucial role in ensuring regulatory compliance throughout the study execution process. They manage trials in the Clinical Trials Information System (CTIS), handling key tasks related to the study's life cycle. This includes notifying relevant authorities of study milestones, preparing and submitting amendments when applicable, reporting serious breaches, unexpected events, and safety measures, and submitting annual safety reports in a timely manner. Their support ensures that each trial adheres to regulatory guidelines, maintaining the integrity and compliance of the entire study.
For more information see our regulatory brochure: download
Close out
CHDR offers comprehensive regulatory support by providing annual progress reports to the EC, ensuring compliance with mandatory reporting requirements for ongoing research. Additionally, CHDR facilitates the submission of the clinical trial report (M3) and/or any relevant scientific publications within one year of the global study completion as per regulatory requirements.
