We provide a streamlined approach to safety submissions, harnessing our cloud-based safety database solution which offers accelerated and pre-configured system deployment.


PrimeVigilance’s offering includes Oracle Argus Advanced Cloud solution comprising of several modules to facilitate end-to-end case processing and reporting and it is currently hosted for many global pharmaceutical companies.

We offer and manage a pre-packaged and validated environment ready for rapid implementation to our customers with minimal resource demand, facilitating effective deployment of the leading global safety database to our clients.

This cloud based, fully CFR Part 11 compliant, safety database solution offers:

  • Full workflow traceability from the moment the case is booked into the system through to archiving
  • Customizable product and study libraries to accurately capture all client specific product license and study information
  • The ability to produce all required regulatory and aggregate reports including:
    – CIOMS and MedWatch
    – E2B (both R2 and R3)
    – PBRER, PADER and DSUR listings
  • Electronic and automated reporting using Gateway
  • Remote access from any location via the cloud
  • Multi-tenant and fully validated.

Our proprietary technology, Automated Smart Processing PV Platform (ASaPPV) – Adverse Event intake and processing solution combined with the existing suite of technology systems – is a scalable and client-agnostic platform that allows efficient handling of volume surges. ASaPPV has augmented process efficiency, quality and productivity through reduction in manual interventions and data standardization. Full case digitization, supporting automatic data submission into safety databases (safety system-agnostic), will be realized in due course.


Our reporting services are supported by our safety teams in the US, UK, Croatia, Serbia and Japan and include:

  • Web-portal submissions to regulatory authorities and ethics committees
  • EudraVigilance and FAERs submissions
  • Gateway submissions through safety databases
  • XEVMPD data entry and maintenance incl. the PSMF number (MFL EVCODE)
  • Investigator submissions by electronic web portal
  • Reporting and evaluation of adverse incidents in adherence to the vigilance system and to Post-Market Surveillance reporting requirements
  • Case reportability assessments
  • Translation services
  • Vendor management.

PrimeVigilance’s clinical and post-marketing reporting capabilities are supported by Ergomed’s Clinical Research Regulatory Affairs, through monitoring individual case and aggregate reporting requirements.

In the age of synthetic datasets developed by regulators, we believe that balancing technological and human power will decrease costs and increase efficiency. PrimeVigilance keeps track of scientific and technological trends, with a view to continually optimize our internal PV ecosystem and embrace AI technologies, when they are acceptable by regulators. AI in the context of PV is more than algorithms.