SynRG provides a comprehensive SAE reporting. In case of SAE, the investigator reports immediately to the CRA on duty. Initial report is passed on to the sponsor within one working day. SynRG submits final report received from / approved by the Sponsor to investigators; investigators are responsible for SAE reports submission to the Local Ethics Committees (LECs). SynRG follows up with investigators on safety reporting to LECs.

Our Safety Management services include:

• Safety plan development
• SAE reporting to Sponsor
• Writing of SAE narratives
• SAE reporting to clinical investigators
• Active search for non-reported SAEs in source documents and CRFs
• Safety reporting to local Competent Authorities and National / Central Ethics Committee