Aptiv Solutions, the US-based provider of biopharmaceutical and medical device development services created through the merger of six companies in February, has set up an Adaptive Clinical Trials Innovation Center made up of thought leaders in the design, methodology and implementation of adaptive studies.
The Innovation Center experts will work to improve the drug development process through the use of adaptive designs, Aptiv said. According to Reinhard Eisebitt, executive vice president and head of the Innovation Center, 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”.
The experts already provide consulting services to pharmaceutical and biotechnology companies, as well as regulatory authorities, on best practices in the field, including assistance with trial design, simulation and execution, developing software tools for adaptive trials, and working with project teams in clinical operations, data management and statistics groups during study conduct.
Reinhard has 25 years’ in the contract research industry. He co-founded ClinResearch, a contract research organisation that specialised in the planning, execution and reporting of adaptive clinical trials, and co-founded software company ADDPLAN, credited with having developed the first commercial adaptive trials software.
Both ClinResearch and ADDPLAN were among the six biopharmaceutical and medical device services companies that merged to form Aptiv Solutions in a move led by an investor group including SV Life Sciences, The Halifax Group and the Comvest Group.
Among the other Innovation Center leaders are:
- Judith Quinlan, senior vice president of trial design implementation and former vice president, adaptive clinical trial services at Cytel;
- Andrew Grieve, senior vice president of clinical research methodology and former Professor of Medical Statistics at King’s College London in the UK;
- Vladimir Dragalin, senior vice president of software development and consulting and former head of the Quintiles Center for Statistics in Drug Development;
- Gernot Wassmer, senior vice president and principle software architect for ADDPLAN, a company he co-founded. Wassner is also adjunct professor of medical statistics at the University of Cologne in Germany.