CROs form new industry standards group to improve collaboration

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Align Clinical CRO to create open technology standards that make it easier for life sciences companies and CROs to work together during clinical trials

Six leading contract research organisations (CROs) and Veeva Systems (NYSE:VEEV) have 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.

For the first time, leading CROs, including ICON plc, Medpace, Pharmaceutical Product Development, LLC (PPD), PRA Health Sciences, Syneos Health, and UBC are coming together to develop open technology standards to transform clinical trial operations across the entire industry to speed product 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.

Align Clinical CRO will post its Operational Data Exchange standard for public review and input later this year, which will also be reviewed and considered as part of the adoption of proposed standards.

Henry Levy Align Clinical CRO President said “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.”