It is necessary to capture and document all aspects of clinical trial before, during, and after trial completion, to ensure the rights, safety and wellbeing of the trial subjects are protected and the reliability of data are maintained. Prodia the CRO supports the clinical trial study document development to meets the trial purposes, assisting client to generate scientific, reliable, and traceable study documents.
Through our year-long experience in preparing submission documents and our wide coverage of therapeutic area, as well as our established networking with local KOLs, we will provide you with fresh insights that you might not find elsewhere. Supported by experienced personnel, Prodia the CRO will help providing study documents which meet the principle of ICH-GCP guidelines and the local regulations. This service is customized based on the clients’ clinical trial specific needs.
Our capabilities of study document development is including but not limited to: