Aptiv Solutions, a US-based medical device and biopharmaceutical company, has introduced AptivInSite, a new adaptive monitoring methodology.
Developed for medical device companies, AptivInSite helps in maximising trial efficiency while maintaining quality of data and substantially reducing the cost of outsourced services. This methodology is also being developed for drug trials, along with a new algorithm for risk-based monitoring.
Adaptive monitoring addresses the cost and approach to site monitoring, which forms a major proportion of a trial budget.
Adaptive monitoring methodologies are not only flexible but also designed to the particular requirements of the trial, unlike conventional trial on-site monitoring practices, which are based more on frequency.
This new approach reduces the requirement for complete source data verification as it uses remote, centralised and data-driven practices to monitor core study parameters with regard to subject safety, data quality and trial risk in real time.
AptivInSite looks at the scope and nature of monitoring needed for a particular trial, after considering the strategy for source data verification, which in turn is based on the aim of the study, protocol design, complexity, size, critical data points, risks and primary and secondary endpoints.
On applying the new monitoring algorithm to studies that have been designed using regular monitoring practices, it becomes evident that AptivInSite can reduce outsourced study costs by 35 to 45%, the company claims.
Aptiv Solutions CEO, chairman Pat Donnelly noted that the medical device industry is undergoing rapid change and has a particular need to optimize clinical trial strategies for efficiency and productivity.
"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," Donnelly added.