Our Solutions
PV compliance monitor is a highly configurable solution offered by jnr consulting llc, which helps drug safety or pharamacovigilance departments of pharmaceuticals and biotech companies to not only monitor retrospective compliance but to have complete oversight of the cases in workflow. pv compliance monitor's integrative dashboards, charts and tables allow users to get to a case without going back and forth to safety.
ICH(International Conference on Harmonization) has changed its E2B ICSR standard from R2 to R3 using the HL7:
- Chapter IV of the commission implementing Regulation (EU) No 520/2012 refers to the possibility of organizations to use this ISO ICSR standard from 1st July 2016 onwards[IR Art 26].
- Companies are currently using Argus Safety System which is built upon E2B R2 Guidelines
The ability to receive E2B files in either format and convert to the other format for transmission or processing.Product Feature:
- Backwards and Forwards Compatibility (R2->R3 & R3->R2)
- Compare E2B (R2) and E2B (R3) tag by tag.
- Dynamic mapping of R2 and R3 data elements.
- Currently,JNR Consulting group team is working to integrate Identification of Medicinal product (IDMP)guidelines within JNR Accelerators by early Q2 2016.
Seamless integration with safety systems (Argus and ARISg) without running into additional infrastructure or software overhead. Our solution is compatible/configurable with both application suites.
PV Compliance monitor is a proprietary solution owned by JNR Consulting Group which helps executives of Global Pharmacovigilance departments to have an oversight into the day to day operations of the Safety systems.
Highly configurable solution offered by JNR Consulting LLC, helps companies to be proactive rather being reactive as it gives the live information of the cases in different workflow states in interactive format with drill down feature allowing user to get to a CIOMS form of the case. PV Compliance monitor also allows users to assign action items to the users with system sending them the notifications. PV Compliance Monitor's CAPA workflow capability not only allow users to create CAPA's however, have full workflow from creation -> assignment -> Approval -> Details with notification feature to the user.
21st century technology used in PV Compliance Monitor make it's user experience great enabling them to take decisions quickly without loosing any critical time.