Align Clinical CRO is an industry standards group founded last year by Veeva Systems and several contract research organizations (CROs), including Icon, Medpace, Syneos Health, PPD, PRA Health Sciences, and UBC.
Henry Levy, president of Align Clinical CRO, said the new standard outlines a consistent way for CROs and sponsors to exchange milestone and metrics data, including general trial information, as well as study start-up and patient enrollment information.
It also provides technical considerations when developing APIs for clinical trial systems, according to the organization.
“The standard will allow technology companies to develop simple data exchange solutions to remove the cost and burden of CROs providing custom data exchange capabilities for every trial,” Levy told us.
“Ultimately, this can simplify the effort of integrating this data within the sponsor and provider greater oversight into important milestones and metrics throughout a clinical trial,” he said.
The standard was developed over several months with input from cross-functional domain experts from eight CROs.
Levy explained, “It was important to the group to develop a standard that was complementary to existing technology standards and be open and free for anyone to use.”
In line with this, the standard is now available for industry review and input through March 15, 2019. The final standard is slated to be available in spring of this year.