The data needs of a global pharmaceutical firm required a central data repository across multiple Electronic Data Capture systems to tease greater insights out of clinical drug trials and to meet regulatory requirements.
Objectives:
- IT Objective: Implement a new data system to allow for structured and unstructured data to be extracted, loaded and processed.
- Business Objective: Reduce cost and time-to-market while increasing data quality and accuracy
Approach:
Inspired Intellect implemented a Data Capture Hub (DCH) to:
- Ingest raw data from a diverse variety of enterprise systems
- Harmonize, map and transform data into consistent structures
- Provide APIs and services to access and consume data for operational and regulatory compliance
Outcomes:
Through our engagement, the client modernized their infrastructure to a production ready system capable of managing the capture, transformation and consumption of clinical trial data. This data hub solution:
- Enabled SMEs to define and configure data processing rules
- Produced adverse event reporting for regulatory compliance
- Established a foundation for building additional data services in the future
Impacts:
- Significant increase in accuracy and timeliness of the reporting of Adverse Events – one of the most important features of the clinical trial process, as it impacts the safety of the patient.
- Planned retirement of obsolete & costly systems, with minimal business disruption during the transition
- Increased access to critical data for mission-critical business processes
