Contract research organizations (CROs) play a critical role in supporting drug development. Clinical outsourcing is projected to increase to 50 percent by 2020. As sponsors conduct an increasing number of trials with multiple CROs, the development of pre-competitive industry standards will assist in bringing more consistency to trial management and addressing the complexity of trial oversight to make drug development processes more efficient and cost-effective.
Align Clinical CRO, an industry standards group founded by Veeva Systems and six of the world’s largest CROs (ICON plc, Medpace, Pharmaceutical Product Development LLC, PRA Health Sciences, Syneos Health, and UBC), has come together to create open technology standards to improve trial execution and collaboration with life sciences companies. The objective is “transforming clinical trial ops” to speed up development, making it easier for sponsors and CROs to work together during clinical trials, reports Ben Adams in Fierce Biotech.
Align Clinical CRO wants to make things “cheaper, quicker and more effective,” the article says. The consortium’s initial achievement will be an "Operational Data Exchange" standard that attempts to share information between the CROs and sponsors. It will define “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,” according to the group, which will post a draft of the standard for public review and input later this year. Feedback could be incorporated into the new standard.
According to Henry Levy, president of Align Clinical CRO, “There is tremendous potential to enhance clinical trial execution with common technology standards that benefit the entire industry. 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.”
As Thomas O’Leary, chief information officer at ICON, explains, “Leading experts are coming together in Align Clinical CRO to streamline how data is shared between CROs and sponsors during trials. We look forward to contributing to the group and creating standards that drive greater speed and productivity across the industry.”
Michael Brooks, executive vice president of product registration at PRA Health Sciences, adds, “This is the first time CROs are coming together to make this commitment to transform clinical trials across our industry...This shows our mutual commitment to make the drug development process more efficient and to help bring needed therapies to market more quickly.”
“Align Clinical CRO will help speed the timeline for gaining new therapy approvals for patients,” says 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.”
Mark Roseman, senior vice president of clinical operations at Medpace, says,“Align Clinical CRO will play an important role in helping the industry accelerate innovation and get new treatments to patients faster. We are excited to join forces with like-minded CROs…to move the industry forward…”
“UBC is excited to join Align Clinical CRO,” states Brett Huselton, senior vice president of commercial strategy for product and opportunity development at UBC. “We are committed to developing open technology standards that benefit the entire industry and make clinical trial processes more efficient.”