Innovative Technology Enables Nimble Phase I Services
Morrisville, NC, USA – Worldwide Clinical Trials, Inc. (Worldwide), an award-winning, full-service, midsize, global contract research organization (CRO), has successfully implemented ClinSpark®, the eSource platform for Phase I clinical trial automation by Foundry Health.
Phase I trials focused on first-in-human studies and early clinical development are increasingly complex, highly scientific in nature and under tight timelines. At the same time, study sites struggle with labor-intensive data collection and transcription processes.
Worldwide has an ambitious innovation agenda to change this dynamic by delivering real-time access to high-quality data throughout the process. This is critical to delivering the same level of customer focus people have come to expect in other areas of their lives. The study team should be able to design and implement clinical trials that give the right answers, in the most simple and unobtrusive way possible for patients, sponsors and regulators. Worldwide implemented ClinSpark, a web-based electronic data capture system specifically designed for automation of Phase I clinical trials, to fulfill this need. All Clinical Pharmacology Unit (CPU) systems and devices connect into ClinSpark, for access to all study data in one place.
“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 J. Atiee, M.D., vice president, Medical and Clinical Lab Director, for Worldwide. “ClinSpark gives me instant access to the critical information required to monitor the progress of our trials – anywhere I can access the internet. We are improving logistics, patient communications and data reporting, all of which are critical factors in keeping trials running smoothly and efficiently.”
About ClinSpark by Foundry Health at Worldwide
Worldwide has completed more than 40 studies to date on the ClinSpark platform. Specifically designed for Phase I trials, ClinSpark is CDISC ODM certified, Part 11 compliant and HIPAA compliant. It supports the total process from recruitment through data collection and all the way to data export. It provides barcode support and countdown timers, as well as integration with virtually any medical device, such as vital signs monitors and electrocardiogram (ECG) machines. It has a bidirectional interface with Worldwide’s clinical laboratory.
“It is fantastic to see ClinSpark supporting the whole workflow in such a large Phase I unit like Worldwide, where multiple studies are running concurrently,” said Brock Heinz, CEO of Foundry Health. “The positive feedback that we receive from happy Worldwide staff and the benefits they realize from having a much more efficient dataflow is highly motivating to our team. It adds to our commitment to keep further developing the industry’s leading Phase I eSource platform.”
ClinSpark enables Worldwide to accelerate the time from study set up to database lock. ClinSpark also enables real-time electronic data and remote data monitoring, as well as statistical analysis with real-time visualization of data to reduce documentation errors. And, ClinSpark marries procedure to equipment use, enabling efficient equipment management.
For more information, visit https://www.clinspark.com.
About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 2,000 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services.
With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO.
For more information, visit http://www.worldwide.com.
Worldwide Clinical Trials