Sarepta Accelerates Data Review for Rare Disease

Challenge

Given that Sarepta conducts clinical trials within a very vulnerable patient population, it is critical for them to move quickly and rapidly analyze data to assess the safety and efficacy of its treatments. In order to manage these trials effectively, Sarepta needed to work with technology and service partners who understood this sense of urgency and could meet their many data demands. This included the ability to create standard, reusable libraries for case report forms and edit checks that could be used across trials to save time during setup and to reduce build costs. The team also required technology platforms that would allow them to access and review data from numerous sources in a centralized, precise and clean version of data that all stakeholders could work from for data review, exploration, and visualization.

Solution

eClinical Solutions and Medidata are trusted partners with a close collaboration that spans more than 12 years. Through working with Sarepta, the team has developed a close collaboration to enable a very efficient data management process to help the company meet its goals. As a result of this data-centered partnership, data management has greater visibility and control over data with the combination of Medidata and the elluminate Clinical Data Cloud® . This hub represents one place that ingests data from all sources and is closely integrated with Rave EDC along with patient-focused data streams, labs, biomarkers, and other data sources that are included in the trial. elluminate also provides Sarepta with centralized analytics that supports clinical, medical, and safety review.

Result

By partnering with both eClinical Solutions and Medidata, Sarepta has increased the standardization of its trial designs and streamlined its data collection strategy. The benefits to Sarepta have included faster study starts and the ability for the Sarepta team to review information immediately with a focus on the most critical data needed for analysis. At Sarepta, trials move quickly, and the ability to accommodate protocol amendments rapidly is critical. Today, after collaborating on 20 trials, 95% of forms and 50% of edit checks are reusable, which facilitates rapid study startup.