ERT launches online gateway to cardiac safety data

eResearch Technology (ERT) has launched a new web interface aimed at enhancing the accuracy and efficiency of cardiac safety data management in clinical trials.

Replacing the previous Digital ECG Community, My Study Portal provides secure 24/7 access to a centralised environment for viewing and managing cardiac safety data from anywhere in the world, on demand and in real time, ERT said.

According to the US-based supplier of centralised electrocardiogram (ECG), electronic patient-reported outcomes, eClinical technology and other services, My Study Portal is the industry’s only dedicated clinical trial portal compliant with the US regulations on electronic records and signatures in 21 CFR Part 11.

“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,” commented Julie Nelson, ERT’s director of online reporting services.

Powered by the company’s proprietary EXPERT workflow-processing technology, the new portal is designed for use by both sponsor personnel and investigator sites.

Sites can self-qualify and access information online in real time, including annotated ECG waveforms, as well as resolving queries, ordering supplies and accessing key study information. Study personnel can use the portal to track the progress of their clinical trials.

Key cardiac safety information is continuously updated, including ECG findings and interpretations, ECG quality, abnormalities, query resolution and other study metrics, ERT noted. Study reports can easily be generated against live data from the EXPERT data management system.

ERT recently tightened its focus on the company’s core cardiac safety and ePRO operations by selling its electronic data capture business to EDC specialist OmniComm Systems.