Regulatory Services
Main Tasks:
- Preparing all submission package for Competent Authority/Ethics Committee
- Initiating process for translation of documents as applicable (e.g. Inform Consent Form, Synopsis)
- Preparing/adapting Country Secific Inform Consent Form and other documents according to CA/EC requirements
- Initiating submission and maintaining correspondence with CA and EC during all study period
- Safety reporting to CA and EC
- Generating progress reports
- Preparing and timely submitting End of trial notifications
- Organising study supply logistics, including obtaining import and export licenses
- Coordinating timely and quality data collection