Product/Service

Clinical Product Safety

Source: Sentrx

Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population.

Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population. A properly managed pharmacovigilance plan serves as the foundation for optimizing and upholding the safe development and administration of new drugs.

As experts in Drug Safety, Sentrx understands that no two companies face the same safety challenges.  Be it early stage development of a new compound, later stage clinical development, expansion needs related to a new launch, legacy case migration, or reporting needs, Sentrx provides an expertise that enables us to grasp your situation quickly and easily and create targeted solutions with a rapid turnaround time, without disrupting your operations.

Contact us today to find out more about our Clinical Services, and our commitment to partnering with you to provide a scalable pharmacovigilance solution to fit your evolving needs.

Clinical Services:

  • Analysis of Similar Events
  • DSUR Preparation
  • End of Study Unblinding
  • End Point Analysis
  • EU Responsible Person
  • IND Safety Report Preparation
  • Investigator Notification
  • Line Listing Generation
  • Literature Search
  • Monthly Line Listing Monitoring
  • SAE Triage
  • SAE Analysis and Coding
  • SAE Medical Review
  • SAE Data Entry
  • SAE Data Migration
  • SAE/EDC Reconciliation
  • Shared Staffing/Dedicated Staffing Models