GlobVigilance

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Automation Tools

Home > Automation Tools

SMART EV TRIAGE

1) PvD’ Code - A cloud -based software tool that automates the triage process of segregating and reconciling applicable cases from other non -relevant cases
2) Reduces manual efforts required to separate the cases relevant to the MAH and for duplicate checks
3) Offers full interoperability with any PV system or E2B converter of choice
4) Tracking of invalid and duplicate cases for future analysis and review & Speeds case reconciliation

AUTOMATED SIGNAL DETECTION

A unique signal detection Software tool for Pharmacovigilance, combining advanced data mining algorithms with a qualitative review of each identified ICSR of interest, which is the current industry Gold standard.

AUTOMATED MEDICAL LITERATURE MONITORING (A -MLM)

Includes Extraction of article of choice, Evaluation, Medical Assessment, Direct Case Creation, Case processing along with Literature document upload

DOCUMENT AUTOMATION

1) Brings automation to controlled document management (CDMS) for all the aggregate reports for PV operations.
2) End-to-end workflow and lifecycle management for different types of reports
3) PSUR, PADER, RMP, ACOS & Signal Detection support & PV -QA

AUTOMATED ICSR SUBMISSION PROCESS

ICSR SUBMISSION CHALLENGES

• Require number of resources & adherence to rules, varying as per countries, for submission

• A single human error in judging in submissions rules and timelines may result
in a severe regulatory deviation in late submission of the ICSR report.

SOLUTION – AUTOMATED ICSR SUBMISSION SYSTEM

• It helps Clients to submit the cases globally via gateway, which will save a lot of resources (Approx 70%) & time of every PV operations.

“PVEDGE-AUTOSCHEDULING PRO” module configures all the country specific submission rules

The system will fire the country-specific report once the case has been processed and routed to the submission user.

Report directed to the gateway interface will automatically transmit to corresponding regulatory authority as per the reportability of the case

ICSR XML get transmitted

The authority will revert with the acknowledgement through the gateway

SMART EV TRIAGE

1) PvD’ Code
- A cloud -based software tool
that automates the triage process of segregating and reconciling applicable cases from other non
-relevant cases
2) Reduces manual efforts required to separate the cases relevant to the MAH and for duplicate checks
3) Offers full interoperability with any PV system or E2B converter of choice
4) Tracking of invalid and duplicate cases for
future analysis and review & Speeds case
reconciliation

AUTOMATED SIGNAL DETECTION
A unique signal detection Software tool for Pharmacovigilance, combining advanced data mining algorithms with a qualitative review of each identified ICSR of interest, which is the current industry Gold standard.
AUTOMATED MEDICAL LITERATURE MONITORING (A -MLM)
Includes Extraction of article of choice, Evaluation, Medical Assessment, Direct Case Creation, Case processing along with Literature document upload
DOCUMENT AUTOMATION
1) Brings automation to controlled document management (CDMS) for all the aggregate reports for PV operations.
2) End-to-end workflow and lifecycle management for different types of reports
3) PSUR, PADER, RMP, ACOS & Signal Detection support & PV -QA