Jun 24 2013
Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces a novel adaptive monitoring methodology. AptivInSite™ has been developed initially for Medical Device companies to maximize trial efficiency, maintain data quality and substantially reduce the cost of outsourced services.
The methodology is also being developed for drug trials, together with a novel algorithm for risk-based monitoring.
Adaptive monitoring addresses the cost and approach to site monitoring, which remains a significant proportion of the budget for an individual trial. Unlike traditional trial on-site monitoring practices that are frequency-based, adaptive monitoring methodologies are flexible and tailored to the specific design of the trial. This approach reduces the need for 100% Source Data Verification by employing centralized, remote and data-driven techniques that monitor, in real time, key study parameters relating to subject safety, data quality and trial risk.
“The medical device industry is undergoing rapid change and has a particular need to optimize clinical trial strategies for efficiency and productivity,” says Pat Donnelly, Chairman and Chief Executive Office of Aptiv Solutions. “During the past several years, regulatory reform has mandated higher quality clinical data to support labeling claims and post-market studies. The application of a novel adaptive monitoring methodology can introduce substantial trial and program efficiencies. We believe AptivInSite™ has the potential to dramatically reduce the cost of clinical development for novel medical device and diagnostic products.”
AptivInSite™ considers the extent and nature of monitoring required for a specific trial, taking into account the strategy for source data verification which in turn is based on the study objective, protocol design, complexity, size, critical data points, risks and primary and secondary endpoints. Applying the novel monitoring algorithm to studies that have been designed using conventional monitoring approaches indicates that AptivInSite™ has the potential to reduce outsourced study costs by 35% to 45%.
“The AptivInSiteTM methodology was developed through a combination of Aptiv Solutions deep knowledge and insight into the regulatory and clinical aspects of pre- and post-market medical device and diagnostic trials, our proprietary technology platform designed for data-driven, centralized and remote monitoring (AptivAdvantage™) and our leadership position in adaptive design trials where these techniques are essential,” says Donnelly.
A paper providing information on AptivInSite™ can be found at: http://www.aptivsolutions.com/reduce-clinical-study-costs/.
Source: http://www.aptivsolutions.com/