ERT Launches new Online Gateway to Improve Cardiac Safety in Clinical Trials
News Jul 08, 2009
ERT has announced the launch of an online web interface – My Study Portal™. Following the launch of ERT’s new website (www.ert.com), My Study Portal is aimed at enhancing the accuracy and efficiency of cardiac safety data management in clinical trials.
My Study Portal, which replaces the previous Digital ECG Community, is an easy to use web-based portal which provides users with secure 24/7 access to a centralized environment to view and manage vital data, from anywhere in the world - on demand, in real time. ERT’s My Study Portal is the industry’s only dedicated, 21 CFR Part 11-compliant, clinical trial portal.
Julie Nelson, ERT’s Director of Online Reporting Services, states, “We are very excited with the launch of our new My Study Portal product, built upon our proven web-based software solutions. This system provides a comprehensive toolset for monitoring cardiac safety and delivers significant enhancements to our clinical teams. With the advent of site-specific tools to view and respond to queries, order ECG-related supplies and create reports with up-to-the-minute information, this product will drive cost-savings across the entire cardiac safety management process.”
This new portal has been designed for use by both sponsor personnel and investigator sites. Sites can self-qualify and access information on-line in real time including annotated ECG waveforms, resolve queries, order supplies and access key study information.
Study personnel with differing responsibilities, such as clinical trial managers, CRAs, principal investigators and medical monitors, can use the portal to track the progress of their clinical trials. Key information is continuously updated including – ECG findings and interpretations, ECG quality, abnormalities, query resolution and other key study metrics.
My Study Portal is powered by ERT’s proprietary EXPERT™ Technology Platform – a robust, secure and validated clinical-research workflow-processing technology that powers centralized electronic data collection, data management and information exchange. The EXPERT platform is tailored for the requirements of ERT’s Cardiac Safety and ePRO Solutions.
Study data reports can be easily generated against live data from the EXPERT data management system – other than the full custom data set several types of standard reports are available including study and visit tracking, missing visits, unresolved queries, comprehensive ECG analysis, abnormal ECGs and trial summary.
Unlike traditional static reporting portals, this new interactive portal facilitates a wide variety of customer support initiatives from supply ordering to retrieving real time key ECG information that can be reviewed and analyzed by cardiologists immediately.
The Electronic Query Resolution feature allows sponsors and sites to review unresolved queries and respond within seconds. ECG results, findings and alerts can be reviewed in pre-filtered listings and configurable reports using the Live ECG Gateway. Site Qualification forms can also be submitted digitally to ERT for immediate approval.
The ERT customer care and technical support team is on hand 24/7 and resource materials, such as equipment manuals and quick reference guides, can be posted on-line for access anytime during the study process.
This comprehensive set of on-line tools provides functionality to improve the setup, planning and closeout processes of all clinical trials. The content and reporting tools are organized into separate modules that are continuously updated as ECGs are processed to provide up-to-the-minute cardiac data in a clear and concise format.