WebHeart is a proprietary, web-based, validated, 21 CFR part 11 compliant and configurable platform for the management, processing, analysis and reporting of cardiovascular safety and efficacy data including ECG and hemodynamic endpoints. Access to cardiac safety data in real time via WebHeart enables rapid and informed decision making for your clinical trial.
Benefits of conducting your study within the WebHeart platform include:
- Rapid and real-time management of study data via secure internet access
- Configurable for sponsor-specific protocols
- Compatibility with all ECG and ABPM technologies and operating systems
- Centralized storage of cardiovascular data from both single center early phase trials to multicenter global studies
- Role-based, 'rights-restricted' security model
- Regulatory submission-ready ECG data
- No special software, plug-ins, or add-ons required
Data Integrity and Security
WebHeart and associated processes have been developed and are continually enhanced to provide our sponsors with credible trial data that has been evaluated and managed within rigorous quality systems. WebHeart is 21CFR part 11 compliant and has successfully completed multiple external system audits. Disaster recovery and other data security considerations are built in to the platform and our SOPs.
Data Management and Analysis
One of WebHeart's principal features is a world class ECG processing system offering a complete solution for acquiring, displaying, measuring, and managing ECG data and is compatible with all collection sources (standard, hardcopy, and Holter extractions). WebHeart's primary function is to acquire, store, and display digital ECG images for cardiologist review, fiducial marker identification, interval measurements, findings entry, and image annotation. The system's capabilities include data management, scanning and digitization, audit trail maintenance, security functions, and provide digital ECG data for regulatory submission (FDA, EMA, PMDA, and CFDA).
Throughout the course of a study, the BioClinica study team uses WebHeart as the foundation for study tracking and reporting. All study related items (e.g. calls, open DCFs, closed DCFs, site trainings, site shipments, regulatory documents, etc.) are tracked in WebHeart® and can be continually exported for submission to the project team.
The WebHeart® system provides the following Study Management benefits:
- Real-time access to study data and trial status
- Continuous QA monitoring and reporting
- Multi-layered security, using encryption, digital certificates, user, context, and role-based access control, and detailed auditing to ensure data safety and integrity
- MCC metrics reporting based on sponsor specifications