Some of the country’s biggest contract research organizations (CROs) and Veeva Systems have banded together and unveiled an industry standards initiative they believe will facilitate cooperation between sponsors and CROs.
The goal of the new organization, Align Clinical CRO, is to develop technical standards that “vendors that provide systems for the industry could implement to drive adoption,” says Henry Levy, chief strategy officer of Veeva and president of Align Clinical CRO.
“We’re excited about the initiative,” said Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). Broadly speaking, industry change is driven by process improvement, data and technology, and people. “At ACRP, we’re working to develop a framework around roles and responsibilities for the workforce. I applaud the Align Clinical CRO project for trying to drive the data and technology piece of it as well.”
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The group has an aggressive timetable. It plans to set aside six to nine months to develop a given standard. The standard will be open and free to the public, Levy says. “We get these technology companies to build off of it and give us feedback, because once you build a product and start to use it, you get real-life experience that actually makes the standard even stronger.”
First up, an Operational Date Exchange standard to facilitate seamless information sharing between sponsors and CROs. It will include the definition of a technical standard for data to be exchanged between a sponsor and a CRO relating to the operational execution of a trial, including key metrics and milestones.
If all goes well, Align Clinical CRO will create open technology standards to help increase sponsor and CRO productivity, reduce operational costs, and run faster trials.
Improving quality, not necessarily reducing costs, is the driver for at least one member organization. “It’s more about value,” says Michael Brooks, executive vice president of product registration at PRA Health Sciences. As an industry, “it shows our mutual commitment to make the drug development process more efficient and to help bring needed therapies to market more quickly.”
“By creating a vehicle for CROs to collaborate and share actionable insight with sponsors, we can improve operational delivery and streamline the increasingly complex trial process,” says Rachel Stahler, chief information officer at Syneos Health.
Other members of the new organization include ICON plc, Medpace Inc., UBC, and PPD LLC.
Author: Michael Causey