New industry standards group to improve collaboration with sponsors

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 contract research organisations (CROs) and Veeva Systems 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, CROs, including ICON, 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.

“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. As sponsors run a growing number of trials with multiple CROs, developing pre-competitive industry standards will help bring more consistency to trial management and address the complexity of trial oversight to make drug development processes more efficient.

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.

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