Pharma companies require a substantial data entry workforce to accommodate the growing variety of intake sources and formats for adverse event ingestion. Introducing new sources entails the need for decentralized systems, trainings, and process changes.
Manual data entry, being error-prone and time-consuming, diverts attention from other valuable activities like medical reviews that contribute to patient safety.
Conventional systems and teams struggle to handle the high volume and unexpected spikes in cases, as seen during the recent pandemic.
The absence of centralized case tracking and data processing results in reconciliation challenges and inconsistent monitoring.
How it Works
UltraIngest Framework Services streamline the ingestion of adverse events into safety systems from various data sources and formats, maintaining quality and speed, while substantially reducing data entry efforts. Each microservice addresses the challenges specific to its data source.
UltraIngest Framework Services features 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
UltraINGEST Framework Services Benefits
The UltraIngest Framework Services has 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
Ultragenic implemented its Health Authority Integration module of its UltraINGEST Suite, for a US biotechnology company engaged in developing vaccines for emerging infectious diseases, and achieves cost savings of up to 50% with improved data accuracy, speed of case processing, scalability, and regulatory compliances.