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It is always exciting to have our customers speak at Driven. This project is truely a great case study in process and change management. In this session the Lilly team is taking us behind the scenes. Check out the abstract below:
Eli Lilly is a leading pharmaceutical company continuously conducting field trials of new drugs to determine efficacy and receive regulatory approvals. The time required to bring new drugs to market is of vital interest to patients, caregivers, and Lilly alike, as a primary driver is to reduce the time to market for new medications. Site Activation encompasses all the activities required to get a site listed as ?ready for enrollment?, achieving 35 distinct milestones, of which the two major milestones are ?approval to receive the investigational product" and ?approval to enroll patients?. Obtaining these key approvals completes trial readiness and the ability to begin administering the drug to first patient, which completes the ?activation process?.
Until just this year, the activation process was managed with spreadsheets, email, and paper documents. Following a multi-year effort involving six vendor/partners, the new Site Activation solution includes electronic process and data, along with, integration with upstream/downstream and supporting systems. The ISAM solution developed with BP3 provides visibility and accountability across all trials without waiting to assemble reports and can now proactively identify performance bottlenecks and delays. Delays, or incidents, are identified and proactively addressed in order to accelerate progress, reduce activation time and ultimately speed delivery of new drugs to market, contributing to Lilly?s effort to Make Life Better, Faster!