April 6, 2011

Aptiv Solutions Announces the Creation of an Adaptive Clinical Trials Innovation Center

CONTACT: Gillian DellaCioppa
Phone: (508) 597-6238
Email: inquiry@aptivsolutions.com


GREAT FALLS, VA — April 6, 2011—Aptiv Solutions, a global biopharmaceutical and medical device development services company, announced today the creation of an Adaptive Clinical Trials Innovation Center. The Innovation Center is comprised of thought leaders who are internationally renowned experts in adaptive trial design, methodology and implementation. The leaders of the Innovation Center have over 95 years of combined adaptive trials consulting experience and include:

Reinhard Eisebitt, Executive Vice President & Head of Innovation Center

  • Reinhard has 25 years of experience in the CRO industry. He co-founded ClinResearch, a CRO that specialized in the planning, execution and reporting of adaptive clinical trials, and co-founded the software company ADDPLAN, which created the first commercial adaptive trials software.

Judith Quinlan, Senior Vice President of Trial Design Implementation

  • Judith has experience in both the pharmaceutical and CRO industries. Judith held various leadership positions at GlaxoSmithKline where she applied and managed adaptive designs within her business areas, and was also involved in multiple initiatives to promote the use of adaptive designs across GSK. Judith recently joined Aptiv Solutions from Cytel, Inc., where she was VP, Adaptive Clinical Trial Services.

Andrew Grieve, Senior Vice President of Clinical Research Methodology

  • Andy has worked for over 30 years in the pharmaceutical industry where he has championed the use of Bayesian methods and was involved in the development and implementation of Bayesian adaptive designs. Andy recently joined Aptiv Solutions from King’s College London, where he was Professor of Medical Statistics, and previously worked at Pfizer Global R&D where he was Worldwide Head of the Statistical Research and Consulting Centre.

Vladimir Dragalin, Senior Vice President of Software Development and Consulting

  • Vlad is an adaptive designs expert with 25 years experience in developing the methodology of adaptive designs, with over 12 years experience in pharmaceutical industry including positions at GlaxoSmithKline, Wyeth, Pfizer. Prior to joining Aptiv Solutions he led the Quintiles Center for Statistics in Drug Development.

Gernot Wassmer, Senior Vice President and Principle Software Architect of ADDPLAN

  • Gernot co-founded the software company ADDPLAN, the first commercial software package for the design, simulation, and analysis of adaptive clinical trials. Gernot has 20 years of experience in clinical trial consulting for academia and industry and is adjunct professor of Medical Statistics at University of Cologne.

Our Innovation Center experts will work to improve the drug development process through the use of adaptive designs. They are at present collaborating with leading pharmaceutical and biotech companies and with regulatory authorities providing consulting on best practices for the use of adaptive designs. This team of internationally recognized experts works with clients to assist with the trial design, simulation and execution, develop adaptive trials software tools, and work with project teams in clinical operations, data management and statistics groups during study conduct.

“Aptiv Solutions is the only company to combine clinical execution capabilities, statistical and scientific expertise, and a suite of integrated technology to provide clients with a full service adaptive clinical trial offering,” said Reinhard Eisebitt, Executive Vice President and Head of Aptiv Solutions’ Innovation Center. “Over the past decade, we have conducted over 100 adaptive clinical trials for more than 30 sponsors.”

“We are pleased to have attracted such talented experts who have both industry and CRO experience in the design, simulation and execution of adaptive trials,” said Patrick K. Donnelly, Chairman and CEO of Aptiv Solutions. “Aptiv Solutions is leading the industry in the use of adaptive clinical trials, which can build significant efficiency into the clinical development process, enabling sponsors to make the correct development decisions sooner and get the right products to market faster.”

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. Aptiv Solutions integrates the resources and expertise of six recently merged companies: Averion International, Trio Clinical Research, Fulcrum Pharma, ClinResearch, Niphix and ADDPLAN.

Aptiv Solutions provides innovative, comprehensive and proven product development capabilities, built on an extensive portfolio of services and a worldwide team of more than 700 professionals. Visit our website at www.aptivsolutions.com