RESTON, Va.--(BUSINESS WIRE)-- Aptiv Solutions, a biopharmaceutical and medical device development services company, and leader in adaptive clinical trial design, simulation and execution, announced today the launch of AptivAdvantageTM – a unique integrated technology platform for the implementation and execution of adaptive clinical trials.
“Over the last six months we have seen a dramatic increase in sponsor interest in pursuing adaptive design clinical trials. This interest has been stimulated by the realization that adaptive designs can now be implemented through the use of our unique implementation technology. This represents a significant step forward in changing the clinical development paradigm” said Pat Donnelly, Chairman and Chief Executive Officer at Aptiv Solutions.
It is well accepted that adaptive design trials have the potential to dramatically improve the efficiency of the clinical development process at any stage of development. While adaptive design concepts have been available for many years, only recently has implementation been achievable, especially for complex design trials where multiple parameters are being assessed in parallel. This breakthrough is possible due to the development of technologies like AptivAdvantage™, an integrated technology platform specifically designed to support the execution of adaptive clinical trials. Importantly, AptivAdvantageTM is designed to meet the requirements specified in draft FDA and EMA guidance to ensure that trial integrity is maintained at all times.
AptivAdvantageTM is an integral part of the adaptive trial data management process and integrates randomization, electronic data capture and drug supply management. The platform minimizes connection points in the data collection process to provide a flexible and seamless environment for data transfer and analysis. It is a harmonization of technology, process and people that facilitates data driven monitoring and real-time data cleaning leading to timely database lock – all critical features of the effective execution of adaptive trials. Access management is controlled via role-based permissions for all stakeholders including a specific password-protected DMC portal which ensures that only the right data is made available to the right person at the right time.
Michael McKelvey, Chief Operating Officer at Aptiv Solutions commented that “AptivAdvantageTM is a key component of our differentiation as the only service provider to offer both world class design and world class execution of adaptive clinical trials. This unique platform, in conjunction with our specific adaptive trial processes governing biostatistics, data management, project management and monitoring, is driving the wider acceptance and use of adaptive trials. This is a very exciting development for our Company”.
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. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has over 850 professionals in North America, Europe, the Middle East, Japan, and Australia. Visit the website at www.aptivsolutions.com.
Gillian DellaCioppa, +1 508-597-6000
Director of Marketing
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Medical Devices Pharmaceutical General Health