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PV Assessor

Revolutionizing Pharmacovigilance with a Comprehensive Digital Solution

Our client is a leading authority in drug safety monitoring, responsible for managing adverse drug reaction (ADR) reports and ensuring public health safety.

It actively integrates patient and healthcare professional reports to identify and address drug safety signals, with a focus on innovation and patient-centric reporting.

Challenges
  • High Volume of Data: The client processes a growing number of ADR reports annually, increasing the workload for manual case.
  • Labor-Intensive Signal Detection: Identifying potential drug safety signals requires extensive manual review, slowing down decision-making.
  • Diverse Reporting Sources: The client receives ADR reports from various channels, including mobile apps, patients, and healthcare professionals, creating data standardization.
Solution Implementation

Nearshore Macedonia designed a state-of-the-art pharmacovigilance software solution tailored to their needs:

  • Automated Case Triage: Implementing a machine learning-based prediction model to prioritize individual case safety reports (ICSRs), reducing the manual workload on assessors. This feature streamlined the identification of reports requiring urgent clinical reviews.
  • Unified Reporting Interface: An intuitive platform integrated with multiple reporting channels, including mobile applications and patient-centric forms, enhancing accessibility and data quality.
  • Advanced Signal Detection Tools: Statistical algorithms were embedded to detect disproportionalities in ADR data, improving the speed and accuracy of safety signal identification.
Outcomes
  • Increased Efficiency: Automated triaging reduced the time spent on manual reviews by over 40%, allowing client to focus on critical cases.
  • Enhanced Reporting Engagement: User-friendly interfaces encouraged more patient and healthcare professional submissions, improving the ADR database's comprehensiveness.
  • Improved Signal Accuracy: Advanced analytics identified drug safety signals faster, leading to quicker regulatory actions and better public health outcomes.
  • Scalable System: The solution accommodates growing data volumes, ensuring client can continue to meet evolving pharmacovigilance demands.
Conclusion

Through this partnership, our client not only modernized its pharmacovigilance processes but also reinforced its position as a leader in drug safety innovation. This case demonstrates how bespoke software solutions can transform pharmacovigilance operations to meet the complexities of modern healthcare.