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