Through working with eClinical Solutions Data Services as well as the elluminate Clinical Data Platform, 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.
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.
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.
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
“We wanted to work with a subject matter expert,” said Lilia Fenelon, Associate Director of Clinical Data Management at Karyopharm, “someone who knew the technology we wanted to use and could deliver on the use of that technology.”