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Supports Pharmaceutical Sponsors’ RBM Strategies with Spirometry Endpoint Analytics, Alerts and Investigative Site Interventions
PHILADELPHIA– September 28, 2015 –– ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions today announced an expansion to its proven 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 which are often noticed too late for pharmaceutical sponsors to act upon.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.
ERT’s 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
“We are pleased to leverage our experience in supporting close to 500 global respiratory trials to enhance our customers’ risk-based monitoring strategies through the real-time analytics, reporting and site training intervention capabilities of our Centralized Data Surveillance offering,” said Achim Schülke, Executive Vice President, Respiratory Solutions at ERT.
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 U.S. FDA recommendations that pharmaceutical companies leverage innovations in modern clinical trials in order to take a more targeted, risk-based approach to site monitoring.
ERT will demonstrate Centralized Data Surveillance for Respiratory Risk-Based Monitoring and other innovative solutions in Booth 1.E_05 at the European Respiratory Society (ERS) International Congress, September 26-30, 2015 in Amsterdam, Netherlands.
For more information, visit https://www.ert.com/insights-cloud/analytics/centralized-data-surveillance.