RESTON, Va.--(BUSINESS WIRE)--Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, announced today the establishment of the Adaptive Center of Excellence (ACOE). The ACOE is a further development of the growing relationship that Aptiv Solutions has as a strategic provider of adaptive clinical trial services for three of the ten largest global pharmaceutical companies. These three companies also have agreed to join a consortium organized by Aptiv Solutions to develop and implement novel methodologies for adaptive dose-finding trials.
The ACOE will focus on defining, developing and implementing a new execution paradigm for adaptive clinical trials. It is led jointly by Michael McKelvey, PhD, Chief Operating Officer and Reinhard Eisebitt, Executive Vice President of the Aptiv Solutions Innovation Center and Managing Director of ADDPLAN®, the Aptiv Solutions statistical software subsidiary. The ACOE is comprised of a group of 15 senior level individuals from various departments of Aptiv Solutions. They take a multidisciplinary approach to addressing the requirements for integrated design and execution of adaptive trials.
The ACOE has three initial goals:
- Develop breakthrough methodologies for efficiently and effectively executing adaptive clinical trials utilizing our unique internal design and execution resources.
- Embody these methodologies in AptivAdvantageTM, our proprietary technology platform for adaptive trial execution.
- Create joint collaborative partnerships with selected clients to develop novel methodologies for adaptive trial design and execution.
Adaptive clinical trials require a much more focused, multi-disciplinary approach to execution than traditional fixed design trials. Specifically, there needs to be tight integration between the clinical teams, the supporting technology platform, and the processes and working procedures for managing multiple interim analyses.
A key mission of the ACOE is to work closely with our clients on joint projects that address trial execution challenges for sophisticated adaptive designs that will have a favorable impact on the efficiency and productivity of product development. Other focus areas for the ACOE include reducing adaptive trial set up time and introducing improved site selection and patient enrollment strategies, as well as advancing data-driven monitoring techniques. All of these activities will help drive cost efficiency and reduce the time to conduct clinical trials for both adaptive and conventional designs.
“The main challenge we see is to synchronize the design and the execution of adaptive trials which will bring significant productivity benefits to the product development process”, commented Patrick Donnelly, Chairman and Chief Executive Officer at Aptiv Solutions. “We believe that the ACOE will provide innovative ways to achieve this and we look forward to working with our valued clients on some very exciting joint projects”.
About Aptiv Solutions
Aptiv Solutions is a global development services company that is focused on enhancing clinical trial decision‐making, efficiency and productivity in the pharmaceutical, biotech and medical device markets. 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, Eastern & Western Europe, Israel, and Japan. Visit the website at www.aptivsolutions.com.
