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Data-driven innovation for clinical data stakeholders ensuring the integrity, reliability & interoperability of their clinical data
The Challenge
The client faced significant challenges with their Clinical Data Management systems. Clinical data was dispersed across internal Clinical GxP network drives without sufficient audit logs, leading to security vulnerabilities and inefficiencies in data management. Given the decentralized nature of their data management systems, the Clinical Data Management team struggled with effectively sharing data between internal teams and external stakeholders, which slowed down decision-making processes.
Our Solution
Agilisium designed and implemented a tailored Clinical Data Lake solution to seamlessly integrate with the client's existing workflows while enhancing security and scalability. Key elements of the solution included:
Custom Medallion Architecture
Transitioned data from internal drives to a tiered architecture consisting of landing, bronze, silver, and data warehouse layers, ensuring better organization and accessibility.
Orchestration of ETL Pipelines
Leveraged AWS Glue for seamless data integration and Snowpark for efficient data movement between curated layers and the data warehouse.
Tailored Data Quality Framework
A robust data quality framework was specifically designed to validate and manage the client's unique datasets, ensuring the integrity and reliability of their clinical data.
Centralized Master Data Management (MDM)
Implemented a harmonized enterprise data model in Snowflake to manage and optimize relationships between various clinical trial stakeholders.
16/5 Support Model
Established a Managed Services model to handle Incidents, Service Request & Enhancements.
The Outcomes
Platform modernization resulted in significantly enhanced operational efficiency and substantial cost savings.
Cost Savings
$48,000/year cost savings through modernization, with an additional $250,000/year IT Spend savings through optimization efforts.
Improved Operational Efficiency
Automation of data quality checks and improved data sharing, supporting global operations across the US and EU.
Enhanced Security & Regulatory Compliance
Real-time audit trails and a centralized security management system, reduces the risk of data breaches and ensuring regulatory compliance.
Better Data Governance & Insights
MDM datasets can now be more meticulously managed by data stewards, leading to more reliable data insights.
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