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Pharmacovigilance Solutions

Ensure Project Safety

To help your clinical trials run smoother, we have developed a service to handle all aspects of pharmacovigilance for you. As experts in the field of biometrics and medical writing we use the following to ensure your pharmacovigilance is on point:

  • Adverse event (AE) and serious adverse event (SAE) data collection, logging, tracking, coding and case processing.
  • Electronic expedited reporting of Individual Case Safety Reports
  • Preparation and submission of Periodic Safety Update Reports (PSUR)
  • Electronic expedited reporting of Individual Case Safety Reports
  • Literature reviews and summaries
  • SAE narrative writing
  • MedDRA coding
  • AE and SAE evaluations
  • Physician medical review and signal detection
  • Development of risk management plans

Through using our knowledgeable experts you can concentrate on other aspects of the clinical trials knowing the safety aspect is in good hands.

To ensure pharmacovigilance runs throughout your clinical trials complete the Handle my Pharmacovigilance Project form today.

Handle my Pharmacovigilance Project Form

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