ERT, a Philadelphia-based global provider of patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, has expanded its line of centralized respiratory solutions for global clinical trials. The offering enables trial sponsors to improve investigative site performance, trial efficiencies and data quality by leveraging centralized data surveillance to support risk-based monitoring in respiratory clinical research.
ERT’s centralized data surveillance for respiratory trials addresses the patient enrollment and data quality challenges that arise from site training gaps, inconsistent collection processes and even misconduct in spirometry and pulmonary function testing—factors that often are noticed too late for pharmaceutical sponsors to respond. The offering enables trial sponsors to improve investigative site performance, trial efficiencies and data quality by leveraging centralized data surveillance for risk-based monitoring in respiratory clinical trials.
The centralized data surveillance offering supports respiratory trial sponsors’ risk-based monitoring strategies through an investigative site data monitoring plan that includes:
Assessing protocol risks, needs and key performance metrics such as site proficiency, calibration, rest between maneuvers, protocol adherence, acceptable/unacceptable best test review data errors impacting the start of tests, and amount of data with repeatability issues.
Analyzing endpoint data in near real-time to continuously fine-tune the monitoring strategy.
Supporting or executing an intervention plan to address risks and data deviations as they arise, targeting sites for training, on-site monitor visits and other interventions to boost data quality.
Powered by ERT’s EXPERT Central platform and delivered through ERT Insights Cloud, which includes real-time data analytics capabilities, the new offering is consistent with 2013 FDA recommendations that pharmaceutical companies leverage innovations in modern clinical trials in order to take a more targeted, risk-based approach to site monitoring.
