ICON Medical Imaging's ICOSpeedRead consists of a complete, validated package including:
- An Independent Image Review Charter
- A RECIST-based eCRF linked directly to our image management and analysis system
- 24/7 live reporting from the system to keep the team informed of each subject’s status
- A comprehensive, image-enabled, outcomes-based database for internal use or delivery to regulatory authorities.
- All components have been completely validated and comply with GCP and 21 CFR Part 11, including complete audit trail tracking. The system has been sent to FDA and currently is in use for recent oncology submissions.
- The system allows protocol specific configuration and allowing ICON Medical Imaging to begin reading within two (2) weeks. No other competitor offers these components, in this time frame, with this level of quality.