Karyopharm Achieves Clean Data Sets Faster
Next Generation Data Management Strategies for Clinical Trials
Karyopharm Achieves Clean Data Sets Faster with eClinical's Biometrics Services
Through working with eClinical Solutions Data Services as well as the elluminate® Clinical Data Cloud, Karyopharm simplified their data flow. Source data from the Medidata Rave Clinical Cloud along with data from numerous Lab providers and other sources all flowed into elluminate and allowed Karyopharm to expedite the data collection, cleaning, and analysis process.
Challenge
Karyopharm had multiple trials in their pipeline, all in various phases of development, and all on tight timelines. Each of these trials produced large amounts of complex data reported from multiple sites and in varying formats. Rather than devote the majority of their time to data aggregation, cleaning, metric generation, and the manual development of SAE and external data reconciliation, Karyopharm’s clinical operations team decided to outsource these tasks.
Solution
When eClinical and Karyopharm began working together, Karyopharm’s Phase I studies were already underway and needed to be updated to incorporate a more flexible design of the Medidata Rave EDC system which was initially not designed to support the type of protocol amendments that were expected. The company also needed a series of Phase II studies built, and these builds required a complex study design and implementation of the Rave Clinical Cloud. To address these varying needs within a tight timeline, eClinical and Karyopharm instituted an Agile approach.
Results
One of the key principals of an Agile Approach: Build on efficiencies you’ve already designed and build on lessons learned from previous studies. The teams created a system that incorporated adaptive planning, early delivery, continual improvement, and a rapid, flexible response to change, resulting in:
- Four Phase II studies deployed in four months
- Five additional studies and 25 protocol amendments delivered
- Five database locks that provided the data for an FDA Approval in 2019
Related products
Karyopharm simplified their data flow by utilizing elluminate Data Central and Clinical Analytics. They created an adaptive planning system that enabled early delivery, continual improvement, and a rapid, flexible response to change.
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
Through their partnership with eClinical’s Biometrics Services, Karyopharm was able to build on previously designed efficiencies and lessons learned from previous studies. Leveraging Clinical Data Acquisition, Clinical Data Management, Data Conversion and Standardization enabled an agile approach.
Clinical Data Acquisition
Unrivaled data acquisition services include high quality database design and builds using Medidata Clinical Cloud™ for your complex and innovative trials
Clinical Data Management
Our integrated, agile approach separates eClinical from other clinical data management companies by combining technology, process and experience for maximum efficiency
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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We wanted to work with a subject matter expert
Someone who knew the technology we wanted to use and could deliver on the use of that technology.
Lilia Fenelon
Associate Director of Clinical Data Management
Karyopharm
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