Based in Philadelphia, PA, ERT is a global technology-driven provider of customizable medical devices and health outcomes research services. ERT harnesses internet and telecommunications technology to provide stakeholders with multiple modes of available technology for collecting health outcomes data. It is the industry leader in centralized cardiac safety and respiratory efficacy services and also provides electronic patient reported outcomes (ePRO) for multiple modalities across all phases. In the current clinical landscape, these solutions accelerate the efficient collection, analysis and reporting of health outcome data that is increasingly required by regulators. ERT's feature services include:
Multi-mode ePRO Solutions
ERT offers electronic Patient Report Outcomes (ePRO) solutions to collect and manage data pertaining to the quality of life and symptomology of patients. These solutions offer the capability of capturing data in real-time, improving accuracy and accelerating overall processes. ERT’s solutions include device products and operational services for optimized clinical trials including VIAPad (handheld device ePRO), VIAPhone (telephone-based ePRO), VIAPen (digital pen ePRO) and VIAWeb (browser-based ePRO). ERT also offers device customization, worldwide logistics and in-house global and local support to ensure effective trial management.
ERT’s solutions provide support in the follow areas:
• Patient recruitment
• Clinical assessments and diaries
• Monitoring and alerting
• Protocol design and validation consulting
Designed in line with FDA requirements, ERT’s pioneering electronic self-rated version of the Columbia Suicide Severity Rating Scale (eC-SSRS) facilitates compliance with regulatory requirements for prospective monitoring of suicidal ideation and behaviors. The validated eC-SSRS solution, developed in collaboration with the scale lead author, is a cost-effective method of prospectively monitoring for suicidality.
Centralized Cardiac Safety 2.0
ERT's Centralized Cardiac Safety 2.0 utilizes newly developed software technology, within its best in class EXPERT ® operating platform. The technology enables the collection of real time, consistent and high quality information, easing site operations for all stakeholders and delivering better value to biopharmaceutical companies. As a result of the improved data quality and processes associated with the use of centralized cardiac safety, significant cost savings can be incurred, resulting in better science and improved convenience for stakeholders.
In 2010, the Tufts Center for the Study of Drug Development published an analysis regarding the industry adoption of centralized cardiac safety and perceptions from stakeholders. The study findings showed that 97% of participants rated central labs as accurate and 90% rated central labs as efficient. In addition, the study showed that only 33% of ECGs are collected centrally using a core lab, representing an opportunity for efficiency improvement within the industry.
Following the acquisition of CareFusion Research Services, ERT is now the industry leader in centralized spirometry. From device customization to clinical data analysis, ERT provides products and services that ensure the most accurate data and efficient trial management in the industry. ERT’s respiratory services offer the following benefits:
• Quality Control – Feedback to sites about data quality with a grade
• Education – Provide retraining to poor performing sites
• Web Portal – ‘Real time’ view of the data for the monitors and sponsor
• Best Test Review – De-selection process of unacceptable quality data
For more information about ERT's leading solutions visit:
Cardiac Safety Solutions – www.ert.com/cardiac-safety-solutions
ePRO Solutions - www.ert.com/epro-solutions
Respiratory Solutions - www.ert.com/respiratory-solutions