ERT has uploaded My Study Portal, an online web interface 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 that provides users with secure 24/7 access to a centralised environment to view and manage vital data, from anywhere in the world.
My Study Portal is a dedicated, 21 CFR Part 11-compliant, clinical-trial portal.
This portal has been designed for use by sponsor personnel and investigator sites.
Sites can self-qualify and access information on-line in real time, including annotated ECG waveforms; they can also 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 Expert Technology Platform, a robust, secure and validated clinical-research workflow-processing technology that powers centralised electronic data collection, data management and information exchange.
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 variety of customer-support initiatives from supply ordering to retrieving real-time key ECG information that can be immediately reviewed and analysed by cardiologists.
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 improves the setup, planning and closeout processes of all clinical trials.
The content and reporting tools are organised 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.
