Analgesic Solutions announced that the presentation of its signature central statistical surveillance tool for the prospective monitoring of assay sensitivity in clinical trials at the International Association for the Study of Pain symposium in Yokohama, Japan.
Quantitative Data Surveillance System (QDSS) is a novel data monitoring system that has the potential to revolutionize multicenter clinical trial monitoring by focusing on early detection of factors that impact assay sensitivity utilizing statistical process control methods to validate clinical signals.
The system enables deployment of pre-specified interventions to improve assay sensitivity with a goal to help avoid failed trials. QDSS is a major step forward in realizing the Food and Drug Agency (FDA) proposed Risk-Based Monitoring Guidance since it not only manages risks to subjects but it helps to accomplish the goal of improved data quality across all sites in a given clinical trial.
"There are particular factors that impact assay sensitivity over time," said Dr. Nathaniel Katz, Founder, President & Chief Executive Officer of Analgesic Solutions. "By identifying and monitoring for these factors using QDSS in a prospective clinical trial, we have an opportunity to intervene before these factors adversely impact the outcome of the study.
“Ultimately, improving assay sensitivity and data quality has the potential to pre-emptively identify poorly performing trial subjects and sites during the trial, therefore minimizing the risks to study participants, lowering the cost for sponsors and shortening the duration of clinical trials."
QDSS has now been deployed in five distinct international, multicenter clinical trials including over 7,000 subjects, 350 sites in 22 different countries. Coupled with the company's suite of proprietary training tools and consulting expertise, QDSS makes Analgesic Solutions the one stop partner for the conduct of clinical trials in the field of pain research.
Analgesic Solutions, LLC., founded in 2006, is a privately held consulting company and Clinical Research Organization. We are a hands-on team of experts who consult on, and conduct clinical trials in the process of bringing pain treatments to market.
With hundreds of projects completed and ongoing collaborations with regulatory authorities, Analgesic Solutions is the premier choice for providing assistance and implementation tools for successful pain trials.
Clients come to us when looking to develop and commercialize better treatments for pain. Our team, with Nathaniel Katz M.D., M.S., serving as our foremost expert, helps our clients bring their pain solutions to commercial reality.