Independent Image Analysis by Qualified Experts
We perform high-quality, independent evaluations of medical images from multicenter clinical trials and research studies. Our readers are fellowship-trained, US-based physicians selected based on prior experience and sub-specialty training. We offer the following reader expertise:
- Musculoskeletal Radiology
- Vascular Radiology
- Diagnostic and Interventional Radiology
- Diagnostic and Interventional Cardiology
- Cardiothoracic Surgery
- Vascular Surgery
- Otorhinolaryngology (ENT)
- Body Imaging
We place a keen emphasis on reader reliability, training, and QA. Our readers have extensive experience in clinical trials and understand the requirement for consistency and attention to detail. Where appropriate, we produce objective, quantitative measures using validated, computer-assisted methods. We work in compliance with a sponsor-approved Image Review Charter developed by our technical staff and scientists before work is initiated.
Reader Training and Certification
Readers must demonstrate acceptable understanding of the image assessment criteria and review methodologies before participating in a study. Live case discussions, blinded image reviews, and/or mock reads are conducted on pre-selected cases to verify effectiveness of training. To assure minimum variation across readers, certification programs are developed to establish group consensus on the interpretative criteria. Where appropriate, we deploy validated reference atlases to provide guidance to our readers on difficult cases.
Reliability Testing and Performance Monitoring
We perform routine tests of inter- and intra-observer reliability to verify reader agreement and avoidance of temporal drift. Agreement statistics are obtained on select parameters at predetermined intervals and verified against prospectively-defined standards obtained from the literature and prior experience. We perform additional, proprietary tests on each deliverable to verify compliance to predetermined quality standards. Tests are conducted per SOPs and the QA program developed by our internal technical team for each new study.