Services / Pharmacovigilance



The importance of pharmacovigilance is out of question. Its adequate use in terms of clinical investigation supports the adequate progress of medicine and the development of new therapies. For the past few years the changes of legislation and internal processes have generated new requirements on behalf of our clients. Its adequate management becomes especially relevant in projects sponsored by independent sponsors or cooperative groups. Knowing this fact, Evidenze has a pharmacovigilance service from which all activities related to safety may be managed.

Combining our expertise on clinical investigation with our wide experience on creating technology tools validated for clinical investigation managing, a safety and pharmacovigilance database has been developed to carry out a duty as important as drug safety.

The services we can provide are the following:

  • Safety database
  • SAEs and SUSARs assessment
  • Expeditious notification
  • Writing of DSUR and PSUR
  • Review of the safety section of protocols
  • Writing of safety agreements
  • Database reconciliation