A full service Contract Research Organization

Offices in the San Francisco Bay Area and Sydney, Australia

Drug Safety

InClin has an experienced drug safety team to provide safety-related services for investigational new products undergoing evaluation during clinical research activities. InClin drug safety services can be part of a full service project or a stand-alone project.

DRUG SAFETY SERVICES

  • Receipt, evaluation, processing and reporting of safety events using Argus safety database
  • 24/7 Review and oversight
  • Develop safety narratives
  • Reporting safety cases to oversight committees using real time data
  • Develop and prepare submissions for expedited SAEs including MedWatch and CIOMs reports for reporting to regulatory authorities
  • Coordinate with Data Management for AE/SAE reconciliation
  • Analysis of similar events
  • Trend and signal detection
  • Medical review of adverse event, concomitant medications, and/or medical history