RESTON, Va.--(BUSINESS WIRE)--Aptiv Solutions, a global biopharmaceutical and medical device development services company, and leader in adaptive clinical trial design, simulation and execution, announced today a collaboration with Tessella, a world leader in the provision of science powered technology and consulting services, to deliver integrated early phase adaptive design and execution services to the biopharmaceutical industry.
In this collaboration, Aptiv Solutions has licensed the use of FACTSTM, the adaptive trial design software developed by Tessella and Berry Consultants for early phase clinical studies. This, in combination with ADDPLAN®, the adaptive trial design software developed by Aptiv Solutions for late phase confirmatory studies, provides Aptiv Solutions with the complete range of adaptive design capabilities for Phase I through Phase IV studies. Importantly, both design engines can be linked to AptivAdvantageTM, the Aptiv Solutions integrated technology platform for the execution of adaptive clinical trials, making design and implementation for any type of trial efficient and effective.
“Our ability to link both ADDPLAN® and FACTSTM to AptivAdvantageTM 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.
“FACTSTM 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 AptivAdvantageTM and make the implementation of complex trial design a reality,” said Kevin Gell, Chairman at Tessella plc.
All three companies recognize the importance of educating industry on the value and benefit of adaptive trials and will work together on a series of joint marketing activities. In addition, the companies will collaborate to bring new complex design methodologies being developed by Aptiv Solutions 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.
About Aptiv Solutions
Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has over 850 professionals in North America, Europe, the Middle East, Japan, and Australia. Visit the website at www.aptivsolutions.com.
About Tessella
Founded in 1980, Tessella is the international provider of science powered technology and consulting services. World leading organizations choose our unique blend of science, engineering and sector expertise to deliver innovative and cost-effective solutions to complex real-world commercial and technical challenges. Our people are high achievers from leading universities and are passionate about delivering value to clients.
For further information visit our dedicated microsite on http://www.smarterclinicaltrials.com.