The web-based electronic data capture system is CDISC ODM certified, Part 11 compliant, and HIPAA compliant to support study recruitment as well as data collection and export.
The midsized global contract research organization (CRO), Worldwide Clinical Trials, has, to date, completed more than 40 studies on the ClinSpark platform.
Moving forward, all of Worldwide’s clinical pharmacology unit (CPU) systems and devices will connect into ClinSpark.
“Worldwide is making a visible difference by transforming clinical trials to be more rewarding for patients and sponsors by replacing manual processes with innovative technologies that result in richer, more accurate data,” said George Atiee, MD, vice president, medical and clinical lab director for Worldwide in a statement.
“ClinSpark gives me instant access to the critical information required to monitor the progress of our trials – anywhere I can access the internet,” he added. “We are improving logistics, patient communications and data reporting, all of which are critical factors in keeping trials running smoothly and efficiently.”
The digital health company Foundry Health in 2016 announced a collaboration with Biomedical Systems, a Missouri-based clinical trial solutions provider, under which the companies developed a cloud-based data management system to enable sponsors to access data in real-time.