Aside from re-defined financing structures, the most important issue facing life sciences EGCs is the need to increase clinical trial efficiency and productivity so that development budgets are used prudently to support products that have the best chance of market success.
Central to these issues is the development of new technologies and processes that support innovative adaptive trial design and execution whilst ensuring that trial validity and integrity is maintained, a perquisite for regulatory agencies. Only then will innovative adaptive design gain wide acceptance as the new way of doing product development. The uniqueness for Aptiv Solutions is its fully validated adaptive trial design software, ADDPLAN®, coupled with Aptiv Advantage™, its unique technology platform for adaptive trial execution, says Aptiv Solutions CEO Patrick Donnelly. This enables clients to undertake adaptive design trials in a way that satisfies all the requirements of the draft FDA guidance on adaptive design trials, including the maintenance of trial integrity.
Speaking to OneMedTV during OneMedForum this past January, Donnelly discussed current changes that will impact the future of product development and the central role that innovative trial design will play in this.
For more materials discussing adaptive design trials and changing tides, visit the OneMedPlace Educational Module.
From the company: Aptiv Solutions is a global biopharmaceutical and medical device development company that provides a portfolio of innovative services including adaptive trial design, translational sciences, regulatory services, pharmacovigilance, clinical resourcing and the operational support of a global clinical research organization. We have over 850 professionals in North America, Eastern & Western Europe, Israel and Japan