Prescribing Data Architecture to support Clinical Trials

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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