Aptiv marries IT and CRO services to tackle adaptive trials market

Aptiv Solutions has struck another deal to build its technology offerings in support of complex clinical studies with adaptive designs--also known as adaptive clinical trials. The venture-backed contract research organization (CRO) has grabbed a license to Tessella's software for early-stage trial design as part of the companies' broader plan to collaborate in the burgeoning adaptive trials business.   

The collaboration is just one of a number things that make Aptiv, which was formed last year through a series of mergers, something of an outlier in the CRO industry.

Adaptive clinical trials typically suck up a lot of computing power because of the heavy data analyses often required to keep the complex studies on track. However, advances in computing over the past decade have made the studies more feasible to a variety of industry players. Aptiv has built a unique business in specializing in adaptive clinical trials, with the software tools and manpower required to conduct the studies. The Reston, VA-based CRO officially launched last year with the backing of the venture firm SV Life Sciences and the private equity outfit Halifax Group, which helped Aptiv's founders raise $70 million in 2008 to create the company, Aptiv CEO and Chairman Pat Donnelly told FierceBiotech IT.

To hear Donnelly tell it, Aptiv was the brainchild of its founders and investors who believed there weren't any CROs that had the complete package of technology and service expertise related to adaptive clinical trials. Meanwhile, FDA guidance in 2010 on the design of the complicated studies gave a clear signal that regulators were willing to work with developers to approve adaptive trial schemes, which can involve a variety of planned modifications during the course of a study.

"We found that there really was no true service provider that understood the nuances of adaptive trials, the requirements that the regulatory agencies needed, and also some of the software," Donnelly said.

Yet there were puzzle pieces available to rapidly piece together a CRO with the service expertise and IT backbone lacking in the industry. Aptiv is the sum of multiple acquired firms, such as the CROs Averion International, ClinResearch, and Fulcrum Pharma, as well as the clinical trials design software developer Addplan. The company's subsidiaries include Trio Clinical Resourcing and the oncology CRO Niphix in Japan.

The series of deals have quickly given Aptiv size, revenue and global reach; the company now has more than 850 workers, 28 office locations and staff in 18 countries, according to an email from a company spokeswoman.

Donnelly, a former CEO and a founder of a large CRO, PRA International, said his young company had around $125 million in revenue in 2011, much of it from the legacy businesses it has acquired as well as new services from the combined new entity. The company has won a series contracts to work on adaptive trials directly for Big Pharma groups or in tandem with larger CROs, he added. 

It's the early days for the CRO's adaptive clinical trials business, and most of the trials that Aptiv's legacy businesses have conducted were not adaptive designs, Donnelly said. However, that has changed dramatically with the formation of Aptiv.

In fact, part of Aptiv's new collaboration with Tessella not only offers the CRO a key software license, but also calls for the companies to team up on promoting their services. As pharma orders more adaptive trials, Aptiv appears to be in a good position to capitalize on the growth.

- here's Aptiv's release