Aptiv, Tessella in Adaptive Trials Software Pact

Aptiv Solutions and Tessella have formed a collaboration to deliver integrated early phase adaptive design and execution services to the biopharma industry.

Aptiv has licensed the use of FACTS, the adaptive trial design software developed by Tessella and Berry Consultants for early phase clinical studies. This, in combination with Aptiv’s ADDPLAN,  adaptive trial design software for late phase confirmatory studies, enables Aptiv to provide a complete range of adaptive design capabilities for Phase I through Phase IV studies. Both design engines can be linked to AptivAdvantage, Aptiv’s integrated technology platform for the execution of adaptive clinical trials.

“Our ability to link both ADDPLAN and FACTS to AptivAdvantage is another important step in our strategy to make our integrated approach to the design, simulation and execution of adaptive clinical trials the gold standard for clinical development,” said Pat Donnelly, chairman and chief executive officer at Aptiv Solutions.

“FACTS is recognized by the biopharmaceutical industry as the standard for early phase design and we are very happy to be working with Aptiv Solutions to harness the power of AptivAdvantage and make the implementation of complex trial design a reality,” said Kevin Gell, chairman at Tessella plc.

The companies will also collaborate to bring new complex design methodologies to the market. Complex adaptive designs are seen by both industry and regulators as critical to the future of drug development, and the accessibility of such approaches will drive the growth of the adaptive clinical trial market, according to an Aptiv Solutions statement.