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Web-based eSource platform supports activities from subject recruitment through database lock
November 19, 2019
By: Kristin Brooks
Managing Editor, Contract Pharma
Frontage Clinical Services Inc. has implemented ClinSpark, a web-based eSource platform that supports activities from subject recruitment through database lock. This automated solution to paper-based documentation was developed specifically for Phase I clinical trials by Foundry Health, LLC. ClinSpark aims to strengthen Frontage Clinical’s recruitment capabilities through its HIPAA-compliant searchable subject database that is integrated with the Verified Clinical Trials registry. It’s designed to streamline study conduct and augment quality via real-time data capture and dynamic edit checks, barcode technology linking subject identification to study procedures and sample processing, and medical device connectivity. The platform also provides study management transparency with its web-based, role-specific, secure access dashboards and complete audit trail. This fully validated, FDA 21 CR Part 11 compliant system offers dataset output that is compatible with CDISC standards. “The deployment of ClinSpark provides Frontage Clinical with an innovative, agile solution to replace a legacy system of paper source documentation,” said Lisa Diamond, Ph.D., president of Frontage Clinical. “Utilizing its comprehensive set of features and capabilities, we are able to execute early phase clinical studies with a more streamlined workflow, while enhancing quality management and project transparency. We will continue to focus on technological advancements to remain at the forefront of our clients’ drug development needs.” “It was great to work together with the dedicated and enthusiastic professionals of Frontage Clinical,” said Brock Heinz, chief executive officer of Foundry Health, LLC. “The great collaboration with Frontage Clinical allowed for a full implementation of ClinSpark in 10 months, which is a great testament of how well our agile approach to software development and implementation works when teams are working so well together.”
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