Expert Blinded Image Review
Independent Image Analysis by Qualified Experts
MMI provides reliable, independent evaluations of medical images from clinical trials of medical devices, drugs, and biologics. Our readers are board-certified, fellowship-trained, practicing physicians with an average of more than 18 years clinical experience per reader. Our team includes major contributors to the scientific literature and influential members of major professional societies, academic institutions, and directive bodies. Our readers are experienced in the following subspecialties:
- Musculoskeletal radiology
- Neuroradiology
- Interventional radiology
- Cardiology
- Vascular surgery
- Electrophysiology
- Body imaging
Our medical image management team places a high emphasis on producing reliable assessments using the latest image analysis and display technology appropriate to the treatment. In many cases, precise quantitative measurements are produced using validated, computer-assisted methods, some of which is proprietary to MMI. Our readers have extensive experience in clinical trials and trial-related technology, and they understand the requirement for ensuring consistency and attention to detail.
Reader Training and Certification
We conduct extensive training to ensure that each reader is properly trained prior to study participation. Each reader must demonstrate adequate understanding of the study-specific interpretative criteria and review methodologies before joining the study. Test reads are conducted in a blinded fashion on pre-selected cases to verify the correct classification of standard observations. To ensure minimum variation across readers, certification programs are implemented to establish group consensus on interpretative criteria for common assessments. Additionally, a reference atlas of images is produced to support assessments of difficult cases thereby ensuring consistency across readers and across studies.
Reproducibility Testing and Performance Monitoring
Tests of observer reproducibility (inter- and intra-reader) are conducted at routine intervals to ensure long-term reliability of the imaging evaluations. All tests of reliability are conducted on a per-assessment basis for each study. Reproducibility statistics are obtained at standard intervals throughout the study to ensure that outcomes consistently meet or exceed standards obtained from the literature or prior studies of similar treatments. Other performance metrics are collected, including on-time completion rate, absence of errant calls, adherence to commenting standards, etc. Tests are conducted per standard operating procedures and predetermined acceptance criteria.
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