Six leading contract research organizations (CROs) and Veeva Systems introduced Align Clinical CRO, a new industry standards group dedicated to making it easier for sponsors and CROs to work together during clinical trials.
Founding members, with input across the industry, plan to help create open technology standards intended to improve trial execution and collaboration with life sciences companies.
“There is tremendous potential to enhance clinical trial execution with common technology standards that benefit the entire industry,” said Henry Levy, president of Align Clinical CRO. “The assembly of Align Clinical CRO represents an important industry collaboration to improve the trial process and how the industry works together to accelerate drug development.”
Align Clinical CRO will create open technology standards intended to help increase sponsor and CRO productivity, reduce operational costs, and run trials faster. The group’s first standard is anticipated to be an Operational Data Exchange standard to facilitate seamless information sharing between sponsors and CROs. This is expected to 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 milestone information.
CROs play an integral role in supporting drug development, with clinical outsourcing expected to increase to 50% by 2020.