Bristol Myers Squibb’s Journey
Adopting A Modern Data Infrastructure & Analytics Platform
BMS Clinical Data Ecosystem
The BMS vision is to advance clinical development through data-based insights. BMS wanted to ingest, curate, and aggregate multiple clinical data sources so the company can rapidly generate insights that advance clinical and drug development efforts. As BMS worked towards realizing this vision, they focused on two business outcomes:
- Reducing risk. The clinical data platform must improve response times to regulatory queries through faster and easier access to audit trails and data lineage information.
- Improving efficiency. There are four areas where BMS wanted to improve efficiency: 1) Medidata Rave integration; 2) external non-eCRF data loading; 3) query management; and 4) data review and analysis.
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We want traceability of the data lineage from the time that information enters the platform to the time it is sent to downstream systems.
We want the ability to generate that information on-demand, so we are always inspection ready.
David Weigand
Senior Director, Clinical Data Reporting and Analytics
Bristol Myers Squibb
Lessons Learned
Building momentum for user adoption as early as possible is critically important. Converting a more significant amount of reporting content into elluminate earlier would have motivated more people within BMS to use the system sooner. In retrospect, the BMS team recommends eliminating or minimizing phased adoption, if business circumstances allow.
Additionally, the team also identified these lessons learned:
- Early internal alignment is important. This requires end-to-end standardization.
- It’s crucial to set CRO expectations. Although BMS shared standards with CRO partners, vendors didn’t interpret them correctly. Timely communication, training, and test studies could have prevented this.
- Sponsor oversight is required at all stages of a study. Before studies go live and throughout the study lifecycle, there must be a robust process for standardization checks.
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With our new BMS outsourced studies, the main issue was that the CROs didn’t interpret our standards correctly.
We learned that we must provide proper training before starting a study and also do a couple of test studies before bringing data into production. Timely communication throughout the study contract is critical.
Jayabarathi Rajasekaran
Director, Clinical Data Warehousing & Delivery
Bristol Myers Squibb
BMS Adopts a New Clinical Data Architecture with elluminate
Facing an increase in data volume and diversity, BMS began adopting eClinical Solutions’ elluminate® Clinical Data Cloud, Mapper and Clinical Analytics. Initially, they piloted the solution with five early studies that had no critical database lock or analysis milestones, and which contained less data than their larger phase three trials.
Challenge
Bristol Myers Squibb wanted to optimize their data review processes to streamline and improve access to their data. The need to build forms, store huge volumes of data in Medidata Rave and migrate them with post-production changes increased the load on the EDC system.
They wanted to find a complementary solution that would integrate with, and support, Medidata Rave, as well as provide streamlined, governed access to a broad set of clinical data, and to support data curation and data aggregation, enabling generations of insights to advance clinical development.
Solution
elluminate Solution Highlights
- Single access point for all clinical data sources
- Robust analytics capabilities
- Quicker access to accurate data for end-users
BMS streamlined their clinical data flow with elluminate’s importer module for quicker access to clean data, and Mapper for their Consolidated Clinical Views (CCVs). The team is now able to dedicate their time to more productive data tasks like analysis. elluminate has enabled complete visibility into who has access to the data and into the lifecycle of the data, which is vital for clinical trial approvals.
Results
BMS has found great success with elluminate in alleviating the pain points in their previous infrastructure. The platform will continue to compile all data sources into a unified source of data, while creating cross-study analytics reports and enabling deeper insights.
Stage two of BMS’s implementation involves all non-CRF data being imported directly into elluminate. Using elluminate, consolidated clinical data can be easily exported for downstream consumption, which includes areas such as the biostatistics department and other reporting platforms that are used at BMS.
Related products
Facing an increase in data volume and diversity, BMS began adopting eClinical Solutions’ elluminate Clinical Data Cloud, Mapper and Clinical Analytics. With elluminate, BMS streamlined their clinical data flow and compiled all data sources into a unified source, while creating cross-study analytics reports and enabling deeper insights.
Mapper
Powerful data transformation, unification and automation from diverse data sources and formats without programming for submission and analytic needs.
Data Central
All your trial data from every source, one place for integrated review- listings, patient profiles, analytics, queries and issue management.
Clinical Analytics
Comprehensive visualizations and reporting that support safety and efficacy decisions within and across trials, operational analytics that help proactively manage your trial.
Related services
BMS optimized their data review processes to streamline and improve access to their data with Data Conversion and Standardization. They achieved a single access point for all data sources, robust analytics capabilities, and quicker access to accurate data for end-users.
Data Conversion and Standardization
Tech-enabled approach to shorten submission timelines and improved ability to support real-time creation of “submission ready” datasets
elluminate Implementation
Customized implementation services are based on your organizational data strategy and needs to ensure business transformation and ROI
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I’ve been looking for a product like this throughout my career
We’re really excited about the future of what elluminate’s going to bring us and a long relationship with eClinical Solutions.
David Rucker
Business Capabilities Lead, CDW
Bristol Myers Squibb
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