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. We offer 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.
Oracle Argus Advanced Cloud is currently hosted for many global pharmaceutical companies and managed by PrimeVigilance. Our premium safety system has been proven reliable in regional and global projects.
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 which 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 global clinical trial and post-marketing reporting capabilities are supported by monitoring of the regulatory/legislative environment by Ergomed’s Clinical Research Regulatory Affairs Department, for both individual case and aggregate report submissions to regulatory authorities, ethics committees/IRBs and investigators.
Our services, supported by our safety reporting hubs in the US, UK, Croatia, Serbia and Japan, 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 medical device vigilance system and Post-Market Surveillance and to Medical Device Reporting (MDR) – 21 CFR Part 803 – regulation
- Case reportability assessments
- Translation services
- Vendor management.