This case study explores how Arithmos helped a medical device company overcome data silos and fragmented data to achieve a single source of truth for informed decision-making.
A Data Warehouse implementation based on Clinical, RWE (Real World Evidence), Science and Business data.
Data Warehouse implementation: Background and Challenges
The medical device company was building its data governance framework to unlock the power of its data for deeper analysis and informed decision-making. However, their data landscape presented a significant challenge:
- Scattered Data Sources: Clinical data resided in various formats across disparate locations. Raw data, patient records (including signed PDFs), and aggregated analyses from CROs were all stored in separate, non-standardised files on a Windows file system. This fragmented approach made data retrieval, analysis, and further development cumbersome and time-consuming.
- Real-World Evidence Integration: Real-World Evidence (RWE) data collected online held valuable insights, but integrating it with clinical data for near real-time analysis proved difficult.
- Siloed Departmental Data: Beyond clinical and RWE data, crucial information resided in departmental silos, including Science, Quality & Manufacturing (Business), Pharmacovigilance, and Regulatory.
The company identified the need for a central repository. This unified data foundation would house high-quality, standardised data, enabling seamless analysis and unlocking its full potential.
The initial focus was on internalising Clinical Data (Raw Data) and Real-World Evidence (RWE). This comprehensive approach aimed to not only streamline analysis but also expand the scope of clinical data for commercial purposes, ultimately maximising business value.
Data Warehouse implementation: Our Solutions
Instead of relying on a sprawling Data Lake that requires individual queries across various sources, we proposed a more efficient solution: a centralised data warehouse. This warehouse would offer several key benefits:
- Data Homogenisation: All data, regardless of format or origin (Clinical, RWE, etc.), would be transformed into a consistent format. This ensures seamless analysis and eliminates compatibility issues.
- Optimised Resource Utilisation: By consolidating data in one location, the need for repetitive queries across disparate sources is eliminated, saving time and resources.
- Enhanced Data Availability: Users can access comprehensive, up-to-date data readily, facilitating faster decision-making.
Considering the existing infrastructures and expertise of the company, we recommended an Oracle Database Server hosted on a secure Cloud platform.
This solution offers several advantages:
- Automated Data Ingestion: New data is automatically or semi-automatically ingested from various sources throughout the night.
- Landing Zone for Quality Control: A designated “Landing Zone” serves as a temporary storage area where preliminary quality checks are performed. These checks ensure data accuracy and consistency, including verifying timeliness, identifying missing data, and catching failed data transfers.
- Data Transformation and Storage: Data requiring transformation to comply with specific regulations or analysis needs is processed and then stored in readily accessible Oracle tables. This ensures data is consistently formatted and easily retrieved by Business Intelligence (BI) and data analysis tools like SAS Viya.
Ensuring Data Accuracy and Accessibility
Building a reliable data warehouse hinges on two key pillars: data transformation and quality control, alongside long-term archiving.
Data Transformation: Creating a Common Language
The biggest challenge lay in the clinical raw data. CROs often export data in various formats (CSV, Excel, etc.) and with inconsistent interpretations of medical terms and categories (Demographics, Vital Signs, etc.). This inconsistency creates information entropy, hindering analysis.
To overcome this hurdle, we implemented a data harmonisation approach based on CDISC (Clinical Data Interchange Standard Consortium) standards. A set of software tools and procedures were used to transform CRO data into this universally recognised format, ensuring consistent data within the warehouse.
Quality Control: Safeguarding Data Integrity
Throughout the data transformation process, rigorous quality control measures were implemented. This included:
- Data Validation: Stringent checks ensured data accuracy and completeness, identifying missing entries or inconsistencies.
- Transformation Verification: We validated the transformed data to confirm it adheres to CDISC standards.
Data integrity is paramount. By implementing these quality control measures, we ensured the reliability of both the raw CRO data and the transformed data within the warehouse.
Long-Term Archiving: Preserving Data for the Future
Modern data warehouse projects prioritise long-term data availability. Regulatory requirements often mandate data integrity and accessibility for up to 25 years.
We addressed this challenge by implementing software tools and procedures specifically designed for secure, long-term data archiving within the warehouse.
This ensures the company can readily access historical data for future analysis and regulatory compliance.
Client’s Success factors and Outcome
The implemented data warehouse solution transformed the way the medical device company interacts with its data. Here’s how they benefited:
- Faster Data Insights: Unified data enables users to query and analyse information efficiently. This significantly reduces the time and effort previously required to join and analyse data from disparate sources, accelerating decision-making processes.
- Improved User Experience: User access is controlled with role-based profiles. This ensures users see relevant data but cannot modify the source information, maintaining data integrity.
- Streamlined Product Development: Evaluating new products and their features is now significantly faster and more efficient. Collaboration and decision-making across various levels are facilitated due to readily accessible, unified data.
Conclusions
By implementing a centralised data warehouse, Arithmos empowered the medical device company to overcome its fragmented data landscape and achieve a single source of truth. This solution transformed how the company utilises its data, enabling:
- Faster, More Informed Decisions: Unified and readily accessible data streamlines analysis, accelerating decision-making across all levels.
- Enhanced Collaboration: Streamlined product development with improved collaboration and faster evaluation of new products and features.
- Optimised Resource Utilisation: Eliminating the need for repetitive queries across disparate sources saves time and resources.
- Robust Data Governance: Standardised data formats, rigorous quality control, and long-term archiving ensure data integrity and compliance with regulations.
This successful data warehouse implementation serves as a testament to Arithmos’ expertise in helping medical device companies unlock the true potential of their data for improved business outcomes.
About the Author
Filippo Magnaguagno
Senior Consultant, System Integration Services at Arithmos
Theoretical Chemist by education from the University of Padova, Filippo spent over 22 years in the Life Sciences sector drifting through and specialising in Computerized Systems from R&D and Analytical to complex Databasing systems devoted to Pharma GxP, both in Analytical and Documental environments.
Senior consultant in complex projects, where Pharmacovigilance software data analysis is required. Ex-ante analysis of both statistical and technical topics to be covered.
Clinical and Omic’s data long-term archiving management for data warehouse implementation consultant in both Pharma and Medical devices areas, with CDISC approach.
About Arithmos
With deep expertise in the Life Science Industry, Arithmos supports companies in their digital transformation journey to achieve the best value from technology-enabled solutions and excellence in business operations.
Arithmos team share extensive knowledge of the full GxP regulated environment for both deliveries of services and technologies, and our domains range from Clinical R&D, Quality Assurance, Drug Safety & Pharmacovigilance, Regulatory and Medical Affairs
