The new solution, CROScheck, is a set of sophisticated algorithms that were developed in collaboration with two universities and experts in data mining and risk analysis, Andrew MacGarvey, CEO of CROS NT, told us at the DIA Annual Meeting last week in Chicago, IL.
The new clinical trial solution incorporates data management and statistical methodology with technology, which the company said enables sponsors to take either a modular or full risk-based approach.
With the US Food and Drug Administration (FDA) supporting risk-based monitoring (RBM), MacGarvey said the industry will finally see savings from technology that the industry has been touting “for a long time now.”
“The ability to really prioritize the sites I’m going to, and by definition not spending as much time at, will allow sponsors to really focus their money in the right areas,” he explained.
A full-service future
In Europe, CROS NT is evolving into a full-service CRO, MacGarvey said. “We have a strong clinical team we’re building there,” he added.
When asked where the company may be in five years, he said the company will be full service – and data-driven is key.
“We’ll be full service, but I’m hoping that the data-driven aspect will be what’s pushing us and differentiating us,” MacGarvey explained, “and the reason I think that will come to fruition is risk-based monitoring.”
While risked-based monitoring has been an industry buzzword for some time, MacGarvey said he talked to many people at DIA who are now adopting the technology.
“I think it will be adopted more quickly than EDC,” he added, “especially because of domestic policy in the US and worldwide policy in terms of drug pricing and the pressures on companies as a whole.”