Bristol Myers Squibb Case Study by eClinical Solutions

Case Study

BMS Adopts a New Clinical Data Architecture Powering a Digital Health Initiative with Streamlined Data Ingestion Across Sources, Data Review and Access

The Business Challenge: An Increase in Data Volume and Diversity 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. In order to consolidate clinical data views, BMS was using a Medidata custom-built data extract solution for raw data sets. They wanted their raw data to stack together, instead of being simply form-based. They wanted a more standardized approach to make it easier to ingest data across numerous sources with greater visibility and governance. Additionally, an streamlined approach for user access, management and crossstudy analytics was desired. As BMS was continuing use of Medidata Rave for ongoing clinical trials, they wanted to find a complementary solution that would integrate with, and support, that platform, as well as align with their company vision: to 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.

The Solution: eClinical Solutions’ elluminate

elluminate is a unified clinical data platform that seamlessly integrates and combines data from all sources for streamlined data review, exploration, and analytics with full governance and data lineage. BMS selected elluminate as their Clinical Data Workbench (CDW) and began utilizing the elluminate Clinical Data Cloud including the Mapper and Clinical Analytics products. 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.

■ Headquartered in New York, NY ■ Founded in 1887 ■ Working to discover, develop and deliver innovative medicines that help patients prevail over serious diseases

Success highlights ■ Single access point for all clinical data sources ■ Robust analytics capabilities ■ Quicker access to accurate data for end-users

Case Study – Bristol Myers Squibb

Streamlining Clinical Data Flow To address data diversity, BMS used elluminate’s importer model to ingest and clean data automatically from all sources. BMS has set up the importer module to import all data automatically into elluminate, instead of relying on a scheduled import. This allows for quicker access to clean data for end-users. It also allows the system to work more efficiently, because there is no need for large-scale data dumps. Integrating non-CRF data is quick and easy, even as more sources are introduced throughout the trial. With the new architecture, external data is no longer required to be stored in Medidata Rave. The team is now able to dedicate the time previously spent on form design to other tasks like data exploration and further analysis. elluminate has also enabled full visibility into who has access to the data and into the lifecycle of the data, which is vital for clinical trial approvals.

Mapper and Clinical Analytics BMS introduced Mapper to replace the BMS-specific extract tool that was being used for their Consolidated Clinical Views (CCVs). With elluminate, clinical programmers now have the ability to identify and address any issues that happen with data ingestion and loads from external systems, and can quickly take the necessary steps to get data flowing again. They can also control any changes to how content is delivered. With elluminate, BMS has standardized, reusable blocks of code.

With Mapper pushing data into standardized reporting structures, cross-study views are automatically enabled. This makes it easy to compare results across multiple studies and draw greater insights from them. The automated tool for importing and transforming data will also improve analytics capabilities, as new, high quality data will be readily available for analytics.

“I’m really excited about Mapper

and the ability to use an interfacedriven utility to transform data into whatever structure we need. We can transform it for downstream delivery to biometrics partners or into a reporting structure for Analytics or Data Central.” David Weigand Director, Clinical Data Reporting and Analytics

Moving Forward: Data Aggregation Using Elluminate As they begin to adopt more studies into the new architecture, BMS has found success with elluminate in streamlining the clinical data flow for submissions. 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 the 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. As BMS continues to integrate elluminate with more tools and platforms including an MDR system and additional external data sources, the company expects to see improved access to operational data, and enhanced analytics and reporting capabilities. There are also cost savings driven by faster access to data, streamlined data review processes, data lineage and data standardization. For more information, please visit us at: eclinicalsol.com Or email us at: info@eclinicalsol.com

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