EU EudraVigilance Case Management

iSafety End to end EudraVigilance Data Management Solution

Fully Compliant EudraVigilance (EVDMS) Case Management Services

EudraVigilance System

The new EudraVigilance System stringently focus the procedural compliance and implementation including the use of the new ICH E2B(R3) Individual Case Safety Report (ICSR) format, the use of EVDAS for signal detection, IT system implementation/upgrades and pharmacovigilance safety databases.

ISO/ICH E2B(R3) rules apply to safety reporting for initial and follow-up reports, amendment and nullification reports, literature and parent-child cases, and reports from studies.

iEVDMSTM

iSafety End to end Eudravigilance Data Management Solution

iEVDMSTM is aligned with the desired objectives for management of pharmacovigilance functions and process harmonization for enhanced quality to achieve regulatory compliances by virtualization and optimization of the pharmacovigilance data captured across all channels in EU.

Process harmonization allows improving the compliance, efficiency, decreasing operating costs, and improving internal control and interoperability.

iEVDMSTM Processes

  • Download of Eudravigilance Cases from the database
  • Data Screening and Case Triage
  • Case Processing, Quality Review and Medical Review
  • Case submissions to regulatory authorities in EU
  • Process Workflow Integration
  • Pharmacovigilance Analytics for Audits, Quality and Compliance

iEVDMSTM Business Values :

Scalability & Turn-around-time:

The iEVDMSTM offers high Scalability for all processes within 2 weeks of time

Integration:

Flexible, customized and seamless integration of new processes within the same.

Quick reports:

On-demand reporting provides detailed case information, letting you quickly and effectively prepare for and respond to regulatory information requests and audits.

Real-time metrics:

Measuring work in progress let you see current workload and resource utilization to make faster, better decisions on workload rebalancing.