The new industry standards group Align Clinical CRO was founded by Veeva Systems and several contract research organizations (CROs), including ICON plc, Medpace, Syneos Health, Pharmaceutical Product Development LLC, PRA Health Sciences, and UBC.
“The purpose of Align Clinical CRO is to create open technology standards that make it easier for life sciences companies and CROs to work together,” Brett Husselton, senior VP of commercial strategy at UBC told Outsourcing-Pharma.com.
As Husselton explained, the initiative is pragmatic, in that it is assembling full-service outsourced service providers to accomplish three core goals. The goals include: Establishing alignment on common “friction points” within the design, implementation, operation, and management of outsourced research; developing standard data definitions and models; and making the standards publically available.
“Align Clinical CRO will help speed the timeline for gaining new therapy approvals for patients,” added Rachel Stahler, chief information officer at Syneos Health. “By creating a vehicle for CROs to collaborate and share actionable insight with sponsors, we can improve operational delivery and streamline the increasingly complex trial process for everyone involved.”
The group aims to achieve its goals by solving “common pre-competitive industry challenges,” such as sharing operational metrics about trials data during study execution, explained Align Clinical CRO president and chief strategy officer for Veeva Systems, Henry Levy.
“Today information sharing is complex because of the different systems and applications used across sponsors and CROs,” Levy said. “Open technology standards can help remove this barrier and ensure sponsors and CROs can collaborate and execute trials much more effectively.”
The members will create the standards with input from the industry. The first to be released will be an Operational Data Exchange standard designed to facilitate information sharing between sponsors and CROs. Align Clinical CRO will post the standard for public review and input later this year.
“Data exchange is one of the biggest challenges impacting working relationships between CROs and sponsors, which is why Align Clinical CRO is focusing on that as our first standard,” explained Brett Husselton, senior VP of commercial strategy at UBC.
“By establishing a common framework for this data that defines its attributes, operational value, and other variables that can travel with that data and be understood across platforms will allow Align Clinical CRO to deliver a market vocabulary and accompanying dictionary,” Husselton told us. “This will save time and resources for all.”
Levy said the group expects that “a few additional large CROs” will join Align Clinical CRO, with additional technology companies contributing as members as well, over time.
For now, he explained: “Align Clinical CRO is committed to operating with speed, so it will be important that the group remain at the right size to do that.”