Case Study: Large Pharmaceutical Company reaches database lock in less than one month with Clinical Ink SureSource

Accelerating Database Lock via Adaptive Design, Remote Monitoring

Large Pharmaceutical Company needed a way to quickly develop and deploy an indeterminate number of eSource studies for a Phase Ib clinical investigation of an investigational medication delivered through a wearable patch. The company also needed regulatory approval for each new version of eSource and a process for updating select sites every two weeks. It worked with Clinical Ink and its SureSource platform.

Clinical Ink developed a customized parent eSource study and deployed it to all sites, allowing the sponsor to review validated data in real time through a secure web portal. Based on those findings, Clinical Ink created and deployed follow-up eSource studies to select sites every two weeks, securing IRB approval before each release. The sponsor reached database lock in less than one month, compared with more than one year using paper-based data capture, while also speeding adaptive trial decisions and regulatory review.