Clinical Data Integration and Analytics
Problem Statement
This large global pharma company needed a centralized approach to data. Specifically, its goals were to:
- Implement a global central data hub across the U.S. and Europe.
- Integrate clinical and relevant safety data to support safety data reconciliation and benefit risk assessment and associated reporting.
- Establish the ability to integrate data managed by external business partners through a secure platform.
- Improve internal advanced analytics capabilities.
- Streamline the process and time requirements to respond to health authorities and to defend product claims.
ClinHUB is a unique source-system agnostic data aggregation platform specifically designed for clinical research. ClinHUB was purpose-built as a data lake, the data approach of preference for leading companies like Facebook and Google. With ClinHUB, the pharma company was able to:
- Integrate large volumes of complex data from internal systems and external partners, including cloud based sources.
- Leverage a metadata-driven framework to automate data extraction and transformations.
- Compile Dynamic View Engines providing customized views of ingested data based on user needs from trial operations, data management, and biostatistics.
- Enable Information Views at various levels, i.e. Study Specific and Study Independent.
- Standardize captured clinical data to support user analysis/reporting through a Linear Data Model flow.
Approach
Outcome
- A metadata-driven dynamic and automated solution.
- Data standardization for regulatory guidelines.
- Framework for data mining & innovative future capabilities.
Key findings
75%
faster data loading and integration
80%
real-time data access speed
75%
in required change control processes
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