Pharmacovigilance

At SPRI, we have strategic tools and partners that enable us to offer complete safety monitoring and pharmacovigilance services for our clients. Whether you require a comprehensive or partial suite of services, our clinical trial safety experts are here to provide support.

SPRI Clinical Trials is happy to work with a vendor-hosted database or to provide a safety database specifically for your trial. In addition to being well-versed in medical coding, SAE reporting and creation and review of patient narratives, our team is experienced with all the major safety platforms (including ARISg, ARGUS, Clintrace and Oracle AERS), allowing us to better meet the unique needs of each client.

Comprehensive Clinical Trial Safety Services

We’ve chosen three pharmacovigilance (PVG) providers with the capacity to offer comprehensive clinical trial safety services on a global basis. At SPRI, we know that many research sponsors choose to maintain their safety information within one database for the lifecycle of the product, allowing them to pull together their DSUR and PSUR with ease. It is with this understanding that we’ve chosen not to partner with one clinical trial safety provider but to broaden our offerings to meet the specific needs of each client.

SPRI’s clinical trial safety and pharmacovigilance services include:

  • Individual case safety report (ICSR) processing for serious adverse events (SAE)
  • 24/7 safety coverage
  • Medical monitoring
  • Aggregate reporting (safety update reports)
  • Trend analysis
  • Managing events of special interest
  • Unblinding

Contact SPRI Clinical Trials today to learn more about our medical coding, SAE reporting and other pharmacovigilance services. With strategic offices in the United States (New York and North Carolina), Ukraine, Russia, Georgia and Belarus and strategic partnerships in Western Europe and Australasia, SPRI is proud to meet the safety monitoring needs of global clinical trials.