ERT Adds Centralized Data Surveillance for Risk-Based Monitoring to Portfolio of Respiratory Clinical Trial Solutions

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Supports Pharmaceutical Sponsors’ RBM Strategies with Spirometry Endpoint Analytics, Alerts and Investigative Site Interventions

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“We are pleased to leverage our experience in supporting close to 500 global respiratory trials to enhance our customers’ risk-based monitoring strategies," said Achim Schülke, Executive Vice President, Respiratory Solutions at ERT.

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.

About ERT
ERT (http://www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services and clinical consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, electronic Clinical Outcome Assessments (eCOA) – which includes patient-, clinician-, observer- and performance-reported outcomes – and cloud-based analytics and performance metrics. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Switzerland, Japan and Germany. Join ERT on Facebook, LinkedIn, Twitter, and YouTube.

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Christine Tobin
ERT
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