Cardialysis has designed a 100% electronic event (or endpoint) adjudication process for your clinical trials.
This system is not only user friendly and quick but you can decide on the main configuration settings. Whether at home or at the office, an event adjudicator can log on to the WebCEC application any time he or she wishes.
Receipt and Scanning of Event-Related
Documents if not already available as electronic images, event-related documents are digitised at Cardialysis and entered into a tracking system. The quality of the scanned images – including ECGs, chest X-rays, MRI images and QCA recordings – is impressive.
Potential trial endpoints are filtered from the central study database into the Cardialysis system. Cardialysis links the electronic event-related documents to these potential events and assigns the resulting “e-dossiers” to the Clinical Event Committee (CEC) members for adjudication.
Whether at home or at the office, a clinical event adjudicator can log on to the WebCEC application at any time. And without any paperwork; the trial protocol, event definitions, event-related documents and adjudication questionnaire are all on-line. The web-based application itself is protected (by username and passcode) and environment-secure.
The application checks the consistency among the adjudicators’ individual answers instantly. Matching results are final and immediately available for statistical processing. Inconsistently adjudicated cases are typically discussed and resolved during CEC “consensus meetings” (face-to-face or WebEx). Consistency rules can be defined freely.
Advantages for the CEC
- Electronic adjudication at home or at the office – convenient, quick and easy;
- No paper – User Manual, trial protocol, event definitions, event-related documents (including DICOM® images) all on-line;
- Daily overview of current workload and e-mail alerts in case of backlog;
- A 24/7 help desk for technical assistance.
Advantages for the sponsor
- 100% electronic: direct upload of e-CRF data and electronic documents at Cardialysis;
- Central preparation of electronic patient “event dossier” by Cardialysis;
- CEC queries via e-mail;
- Highly configurable – the client decides on user rights and roles, CEC workload distribution, the adjudication and consensus process, etc.;
- Adaptable to trial-specific terminology;
- Centralised document translation module; “time-to-translation” process under full control;
- Immediate adjudication results;
- On-line access to adjudication progress reports;
- FDA 21CFR part 11 compliant;
- Protected (by username and passcode) and secure environment;
- Centralised CEC training by Cardialysis;
- Reduced CEC travel costs due to online adjudication;
- Use of the same system for data safety and monitoring.