Worldwide Clinical Trials to Use Novel Platform to Address Phase I Trial Challenges

Last week, Worldwide Clinical Trials announced it had implemented a new technology platform to help transform the way Phase I trials are conducted.

Early-phase trials carry a lot of weight on a drug company’s path to market approval. They’re often lab-intensive, highly scientific in nature and are carried out under strict and tight timelines. A significant challenge in Phase I trial conduct surrounds efficient data collection, organization and transcription into useful formats for analysis.

The North Carolina-based contract research organization (CRO) hopes to speed study completion and extract more high-quality data with Foundry Health’s eSource platform, ClinSpark.

“ClinSpark gives me instant access to the critical information required to monitor the progress of our trials – anywhere I can access the internet,” said Dr. George Atiee, vice president of medical and clinical lab director at Worldwide, in a statement. “We are improving logistics, patient communications and data reporting, all of which are critical factors in keeping trials running smoothly and efficiently.”

ClinSpark boasts capabilities including multi-site support, remote data monitoring, real-time visualizations, sample specimen management and integration with third-party electronic data capture systems. This platform can also assimilate data collected from Worldwide’s Clinical Pharmacology Unit, a state-of-the-art facility based in San Antonio, Texas which offers various clinical services to over 100 studies each year.

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To date, Worldwide has completed over 40 studies using the ClinSpark platform. Foundry Health has also worked with fellow CRO, Bioclinica, and other software solutions providers like Medidata and OpenClinica.

“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,” added 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.”

A majority of clinical trial professionals agree that proper integration of digital technologies will improve clinical development. Data continues to pour in from disparate sources — wearable devices, electronic patient-reported outcomes and archived samples reanalyzed with modern technologies — and sponsors are adopting novel trial designs to better suit patient needs. These changes affect all areas of the clinical trial process, from study start-up to post-market follow-up.

To meet these needs, CROs are continually partnering with software companies in hopes of uniting clinical expertise with cutting-edge technologies. Worldwide’s latest move could set the stage for a higher standard of Phase I trial execution.