Safety Surveillance

Our team is available on 24/7 response line to take medically related questions or for reporting adverse events. Safety surveillance and reporting services include:

• Review of Protocol, Investigator Brochure, Informed Consent Form, and Case Report Form

• Safety monitoring

• Serious Adverse Event collection, evaluation, classification and reporting to Central IRB/ Sponsor/ Regulatory authorities

• Unblinding during Serious Adverse Event

• Developing safety database

• Periodic safety update reports

• Organize IDMB