Six big contract research companies, alongside Veeva Systems, are for the first time coming together to develop open technology standards aimed at “transforming clinical trial ops” to speed up development.
This new team, known as Align Clinical CRO, works as a new industry standards group that, ultimately, wants to make it easier for sponsors and CROs to work together during clinical trials, while making things cheaper, quicker and more effective.
Founding members—including ICON, Medpace, PPD, PRA Health Sciences, Syneos Health and UBC, with help from across the industry—create open tech standards intended to improve trial execution and collaborations with biopharmas.
“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.”
The group’s first standard will be an "Operational Data Exchange" standard, which is set up to help share 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,” the group said in a statement.
Align Clinical CRO will post its Operational Data Exchange standard for the public to see and comment on later this year. Feedback from this could also go into the new standard.
“Leading experts are coming together in Align Clinical CRO to streamline how data is shared between CROs and sponsors during trials,” said Thomas O’Leary, chief information officer at ICON. “We look forward to contributing to the group and creating standards that drive greater speed and productivity across the industry.”
“This is the first time CROs are coming together to make this commitment to transform clinical trials across our industry and we are excited to be part of this effort,” added Michael Brooks, executive vice president of product registration at PRA Health Sciences.
“This shows our mutual commitment to make the drug development process more efficient and to help bring needed therapies to market more quickly.”