Clinical Trials
CA/EC Approvals
Regulatory submissions are the most critical milestones in the clinical study. National regulations influence the submission and timelines. There are significant differences between countries and sometimes even within countries between local Ethics Committees, in the way they work and what they require. Prior to study initiation, Clinmark ensures that all required essential documents are collected, reviewed, and approved per regulatory requirements. Clinmark’s dedicated team provides a comprehensive range of submission and approval-related services for the customers. We can assist in efficient communication, including:
- Compiling submission packages
- Competent Authority submission
- Ethics Committee submission
- Local hospital board approvals
- Contracting
- Other relevant permission
- Study amendments and study termination