Safety Surveillance

Our clinical research 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