Drug safety and Pharmacovigilance

Pharmacovigilance and drug safety Software

Software with 360* solution management for end to end PV operations. Our safety database has been developed not only to enter the adverse event but to analyze and generate various regulatory reports like CIOMS, XMLs, MedWatch, Line Listing Reports, etc. for submission, which are according to the ICH E2B (R3), 21 CFR Part 11 guidelines and specifications.

Software working on Multi-vigilance case reporting with all latest MedDRA

We offer you the following solution.

  • Individual Case Safety Reports
  • Post Marketing Safety Reporting
  • Clinical ICSRs management
  • PADER Listings
  • Signal Detection
  • Automated Literature surveillance
  • Medical Device Vigilance
  • Vaccine Vigilance
  • Product Inquiry Trial and Response system
  • Pharmacovigilance Academic Module
  • Case Routing and Workflow Management

Software is capable of managing:  

  • Smart EV Triage
  • Multisource Inbox and Triage
  • MedDRA auto-update
  • ICSR (XML) validation tool
  • ICSR Submission, Tracking and Compliance
  • Operational Productivity and Quality Management System

An efficient and fully compliant automated solution to record, analyze, and process the product specific inquiries, medical inquiries, product quality complaints (PQC), and adverse even caused by PQCs.

An efficient literature monitoring solution which should be automated enough to handle all the tasks of medical literature monitoring with very less time and resources for the targeted task… We focused on the pain areas of MLM and developed a completely automated solution which will automate the cumbersome manual operations in Literature evaluation (Primary and Secondary) and further ICSR creation.

Signal detection is a continuous process in safety surveillance. This can be carried out by more than one method depending on what is most appropriate for the given data set. For that case report Pharmacovigilance software provides you tabulation summary of the AE that is based on GVP Module guidelines. It helps for combining advanced data mining algorithm of ICSR.

“A smart EV Triage solution in Pharmacovigilance (PV) operations”.  It automates the triage process of segregating and reconciling applicable cases from other non-relevant cases. Compliant with ICH E2B R3 and GDPR regulations.

Exclusive benefits:   

  • Maximizes efficiencies of a pharmacovigilance (PV) team to focus on more critical tasks.
  • Automation reduces manual efforts with more accuracy.
  • Deploys quickly as a cloud-based plug-in.
  • Auto checking conditions can be modified as per client’s SOP.
  • Pre-validated solution like ready to use
  • No infrastructure requirement
  • GxP compliant solution which has been passed various regulatory audits like USFDA, MHRA, Health Canada, ANVISA, MOH, CDSCO, TGA etc.

For Business Query and Discussion