Veeva Systems in collaboration with six contract research organisations (CROs) have introduced a new industry standards group, Align Clinical CRO, that is dedicated to making it easier for sponsors and CROs to work together during clinical trials.
Collaboration
“There is tremendous potential to enhance clinical trial execution with common technology standards that benefit the entire industry,” explained 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.”
This new group will involve the creation of 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.
