In business, you’re only as good as your last project. But, in the pharma business, quality isn’t just about success…it’s also about safety. It’s our modus operandi to monitor the compliance of expedited reports and evaluate deliverables, with special emphasis on the quality of AE/SAE reports. Ours is a check-and-double-check system.

Our sophisticated quality management check-and-balance system includes strict monitoring using a safety database to chart data entry inconsistencies and ensure compliance. Then we enhance with oversight by our expert medical monitors, moving the process beyond check-and-balance straight to bull’s-eye!

Our globally-positioned medical monitors offer:

  • 24/7/365 “on-call” telephone availability
  • Development and review of eCRF
  • Medical review of AE (MedDRA) and concomitant medication (WHO) coding for accuracy and consistency
  • Participation in team meetings, and help in arranging CRA therapeutic training
  • Preparation and delivery of training/training materials to CRAs and other healthcare personnel
  • Review of safety events, follow-up with sites, reconciliation of event details, and guidance to sites for working through follow-up/next steps
  • Study support for CRA and CSA teams
  • Development and review of SAE reports and production of cogent AOSE documents
  • Review of protocol-related documents and prior study data/literature
  • Development and review of SAP, TFLs, and CSR


Interested in a bull’s-eye approach that perfectly unites QC, safety, and clinical trial success? Contact us.


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