Quality Monitoring Tool for ICSR Helps Pharmaceutical Giant Gain Data Transparency At Highest Level
Industry: Pharmaceuticals
Access to quality score at individual case level for every case processed
Both field-based and case based quality evaluation
No possibility of skewing as data transparency is at highest level
4-eye view of quality score trending
Average time taken per case reduced to 1-2 minutes
Client Overview:
This client is one of the top ten pharmaceuticals, consumer care, animal health, and medical care company driven to discover and manufacture innovative products that will improve human and animal health worldwide.
Quality Assurance of ICSRs is among the most time and resource intensive regulatory requirement. The ICSR QA guarantees that the safety information obtained is reliable and processed in accordance with regulations. From data completeness to data correctness, the ICSR Quality varies a lot depending on various stakeholders.
All ICSR Must Meet The Quality Requirements For Submitting Any Safety Reports To The Regulatory Authorities
The client was facing less visibility on root level errors through centralized dashboard, e.g. missing identified critical errors based on field type, user type, product type, etc. For this the client needed standard vendor comparative quality report across all service providers. This could help in identification of critical errors in less time. It also helps in increasing feasibility of doing Random sampling and help in data transparency. The client needed to take on multiple approach to evaluate quality score like Field Based Vs Case Based.
AiRo’s Customized Cloud-Based Quality Monitoring Tool Wins Client Confidence
AiRo developed a customized cloud-based quality monitoring tool to monitor and track the percentage of quality across all vendors. It helps to create transparency across volumes of cases. This QC tool provides quality comparative reports across service providers. The tool allows targeted case-based feedback on quality improvement initiatives within teams. It also helps to generate comprehensive error types reports based on field type / user type / product type / vendor type. Tool also allowed customizable critical fields on need basis for designated critical errors.
The Client Recorded Significant Benefits Post Deployment
Provides access to quality score at individual case level for every case processedTool caters to both the approaches of quality evaluation e.g. field-based and case basedObviates the need of random sampling to arrive at conclusive quality scoresNo possibility of skewing as data transparency is at highest levelProvides four-eye view of quality score trendingAverage time taken per case 1-2 minutes.
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The AiRo Perspective
AiRo created an intelligent Bot to extract information from the source document and enter the data into the Argus database to create new cases. This required periodic updates for the Bots to comply with revised mapping documents.
