Regulatory

Regulatory activities in a clinical trial ensure that the study is conducted in compliance with applicable laws, ethical requirements, ICH-GCP, and local authority regulations. This includes preparing and submitting required documents to regulatory authorities and ethics committees, obtaining approvals before study initiation, maintaining essential records, managing protocol amendments, safety reporting, and ensuring ongoing compliance throughout the trial. Effective regulatory management helps protect participants’ rights, safety, and well-being while supporting the scientific integrity and credibility of the study data.