Pharma companies need a large data entry workforce to pace up with an ever-increasing variety of intake sources and formats in adverse event ingestion. The addition of new sources requires training and process changes.
Manual data entry is an error-prone, time-consuming, and repetitive job that shifts focus away from other value-added activities like the medical review contributing to patient safety.
Conventional systems and teams are inadequate to accommodate the high volume and spikes in cases seen during the recent pandemic.
The lack of centralized case tracking and data processing leads to difficult reconciliation and unsystematic monitoring.
How it Works
UltraINGEST Framework Services automate adverse event ingestion to safety systems from varied data sources and formats while maintaining quality and speed. The UFS micro-components significantly reduce data entry efforts and effectively solve the challenges associated with their respective data sources.
UltraINGEST Framework Services include:
- Support for varied sources e.g., License Partners, Web Portal, Call Centers, Regulatory Authorities (EV Web, HA Canada), social media
- Data extraction from structured (CIOMS, MedWatch, Custom Forms) and unstructured formats (Narratives, Abstracts, and emails)
- Case Triage ability to prioritize case processing based on the seriousness, case type, and other configurable parameters
- Intelligent self-optimizing duplicate search using proprietary algorithms
- Centralized Tracking dashboards to track, analyze and display key metrics to monitor the health of adverse event intake
- Multitenancy support to integrate with single-tenant and multi-tenant safety systems
- Enabled data security restrictions based on local regulations, drugs, studies, and sites
- Configurable ingestion workflows for each source and data formats
- Exportable audit logs across case intake lifecycle
- Multilingual application interface to accommodate global users and data
- Auto-scalable cloud platform capable of processing thousands of cases simultaneously
- Stay informed with real-time email alerts and push notifications
The UltraINGEST Framework Services have delivered significant productivity gains in the adverse event ingestion process. The key benefits that our clients have experienced include:
- Up to 50% savings in intake cost
- High Performant system with the capability to ingest cases within minutes to Safety System
- Increased focus on value-added activities like medical review
- No case backlog due to automated processing
- Uniform intake process for different sources and forms
- Optimized involvement of data entry team
- Eliminates data entry errors due to human mistakes
- Reduced quality check efforts