A Global CRO

 

Pharmacovigilance

Our highly experienced clinical research physicians provide medical expertise to evaluate the safety and conduct of a clinical trial. Their support safeguards the success of a clinical trial through delivery of high quality clinical data to our customers.

We provide the following services:

  • 24-Hours/7-Days Serious Adverse Event (SAE) reporting and medical coverage
  • Preparation of narratives, Medwatch and CIOMS reports
  • Review of potential subject eligibility
  • Medical review of adverse events, labs, vital sign, ECG's, and any other study related datasets
  • Answer investigational product/protocol related questions
  • Review of Case Report Form design
  • Medical support to clinical sites, clinical research associates, clinical data managers and project teams
  • Coding of adverse events, concomitant medications and other study related data
  • Medical review of all clinical trial related documents i.e. clinical study reports, etc.