Navigating the rules and regulations for clinical trials is a crucial step, and our team is right there on the ground, handling the details and meeting the requirements of the regulatory and ethics authorities.
Clinical Trial Insurance Management
Ethics Committee and Regulatory Authority Support, includes:
- Submission Documents Preparation: We help prepare documents needed for EC and RA submission in Armenia, such as the research plan, consent forms, and other required papers.
- Regulatory Compliance: Ensuring everything follows local and international rules for clinical research in Armenia.
- Submission Process: Assisting in submitting documents to the Armenian EC and RA, making sure they are complete and well-organized. We also keep track and address any questions or concerns.
- Communication: Being the go-between for sponsors, CROs, investigators, and the Armenian EC and RA, ensuring smooth communication.
- Protocol Amendments: If there are changes to the study plan in Armenia, we help prepare and submit them for approval.
- Timelines: Making sure the Armenian EC and RA approval process stays on schedule.