Analgesic Solutions, a consulting and clinical research company with a focus in trails involving pain management, has introduced a central statistical surveillance tool for the monitoring of assay sensitivity within clinical trials.

The Quantitative Data Surveillance System (QDSS) focuses on the early detection of the factors that affect the assay sensitivity control methods used to validate clinical signal. With the to avoid failed trials, the QDSS is a step forward in realizing the FDA’s Risk-Based Monitoring Guidance as it helps improve the quality of data given in a clinical trial. The system has currently been implemented in five international clinical trials with more than 7,000 participants at 350 differently sites in 22 countries.

"There are particular factors that impact assay sensitivity over time," said Nathaniel Katz, MD, MS, president and CEO 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 preemptively 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."