The organisation is a conglomerate that was formed by six CROs, Averion International, Trio Clinical Research, ClinResearch, Niphix, Addplan and Fulcrum Pharma, in February this year.
The firm’s approach is to combine 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 CRO.
Speaking at the official launch CEO Patrick Donnelly said: “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.
“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.
But despite only officially launching today, Renton, Virginia-headquartered Aptiv already has a portfolio of customers as a result of deals signed by its constituent members.
In March preclinical research specialist Ricerca Biosciences teamed up with UK-headquartered Fulcrum Pharma in a partnership focused on improving the discovery and early-phase development of drug candidates.
More recently Aptiv teamed up with Cancer genetics in an accord that will see it provide trial design, regulatory affairs and pharmacovigilance with CGI operational support services, with a particular emphasis on use of biomarkers.