It is critical aspect of clinical trial management to capture and analyze safety data to demonstrate safety as well as efficacy. Our experienced Pharmacovigilance team will ensure to collect safety data accurately and in timely manner.  We have very broad therapeutic experience and provides services as follows:

  • Development of Safety Management Plans
  • Processing of SAEs and Other Events of Interest
  • Regulatory Report Submission for SUSARs
  • Data Reconciliation
  • Line Listing and Summary Tabulation Generation
  • Signal Detection
  • Safety Database Hosting
  • Investigator Meetings
  • Data Safety Monitoring Board Management and Participation
  • Health Hazard Evaluations
  • Protocol Development
  • Audit and Advisory