Chairman and CEO Patrick K. Donnelly today announced the official launch of Aptiv Solutions, a global biopharmaceutical and medical device development services company. The Company has integrated the resources and expertise of Averion International, Fulcrum Pharma, and ClinResearch, these companies now become Aptiv Solutions. In addition, ADDPLAN, the developer of advanced adaptive trial software products, will be a unit of the new company. Trio Clinical Resourcing, a dedicated staffing and functional outsourcing provider, and Niphix, a specialty oncology CRO in Japan, will operate as subsidiaries of Aptiv Solutions.
“Aptiv Solutions is the only CRO to offer design, simulation and execution of adaptive clinical trials - and the only partner to make fully functional adaptive trials a reality. Our focus in adaptive clinical trials is central to our mission of developing unique, comprehensive solutions for the future.”
Aptiv Solutions grew out of a first-hand recognition of the pressures and challenges facing drug and medical device developers - and the belief that a more dynamic paradigm for development is long overdue in the drug development services industry.
Aptiv Solutions combines industry-leading software and expertise in the execution of adaptive clinical trials, specialized medical device development expertise, a dedicated focus on Oncology and the flexibility of an international Clinical Research Organization. These offerings build on an extensive portfolio of services and a worldwide team of more than 700 professionals.
"As of today," Donnelly said, "Aptiv Solutions is the only CRO to offer design, simulation and execution of adaptive clinical trials - and the only partner to make fully functional adaptive trials a reality. Our focus in adaptive clinical trials is central to our mission of developing unique, comprehensive solutions for the future."
According to Donnelly, formerly the CEO and one of the founders of PRA International, "The difficulties facing companies developing products in life sciences have intensified. Companies that continue to rely on conventional techniques risk missing out on new, rewarding opportunities that accelerate alternatives."
To that end, Aptiv Solutions offers a portfolio of customized solutions including early phase product development consulting, clinical trial management services, regulatory strategies and e-submissions, staffing and functional service outsourcing that enable sponsors to get their products to market sooner.
"We don't believe in standing still," added Peter Gonze, Executive Vice President for Business Development. "We're using Adaptive Clinical Trials in all phases of drug and medical device development to help our clients accelerate their products through the development and approval process."
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