Image Review Charter Development
One size does not fit all when it comes to imaging protocols. Our protocols are designed specifically for your treatment therapy, based on the latest scientific literature and regulatory guidance documents.
Experts in Image Analysis Design
Unique treatments require unique image analysis designs. Trust MMI’s experts on the Technical Services team to guide you to the best and proven methods for evaluating your product.
When planning your clinical trial, MMI’s Technical Services team will work closely with you to develop a study-specific Image Review Charter (IRC). The IRC documents the relevant imaging modalities, assessments, and methods used to assess the effect of your treatment. Targeted to the unique requirements of your trial, we develop each IRC based on the latest scientific literature, regulatory recommendations, and clinical guidance of our experts.
Our IRCs are designed to be reviewed by regulatory authorities, IRBs, ethics committees, investigators, and others, as an adjunct to your Clinical Investigational Plan. As part of the IRC development process, our team will also develop an Image Acquisition Protocol (IAP) and an Image Transfer Protocol (ITP). The IAP details how sites should acquire images for the study, including but not limited to details about equipment requirements, subject positioning, acquisition parameters, and tips and tricks to improve image quality. The ITP details image labeling requirements and instructions for sites to transfer images to MMI.
We support image calibration strategies to report millimeter measurements on x-rays through the use of markers such as XCalibR™, MMI’s proprietary X-ray Calibration Ring marker.
Our experience ranges from animal to cadaveric studies, and from digital simulation to benchtop testing studies. Our client relationships often begin at the earliest stages of the product lifecycle. We conduct detailed, quantitative analyses of images obtained during biomechanical, functional, and other testing. Through collaboration with commercial and academic test facilities nationwide, we assess treatment deployment, size, position, function, metabolism, and other metrics.
WHAT WE OFFER
Comprehensive, Literature-Based Imaging Protocols Customized to Your Trial
Customized assessment panel specific to your treatment and study goals
Literature-based, validated assessment grading systems and measurement methodologies
Detailed considerations for image interpretation based on your treatment
Standardization of image acquisition parameters across sites
Instructions for calibration marker and phantom usage
Customized analysis quality control checks based on imaging endpoints and study goals
Developed following the latest regulatory guidelines and suggestions, including defined requirements for image storage & handling, reviewer training, adjudication processes, data management, and data archival
How can we help?
The most useful imaging outcomes result from thoughtful, comprehensive, and customized analysis plans. Let MMI design your next Image Review Charter.
Unsure how best to visualize your unique treatment?
Not sure what imaging assessments you need for your study?
Are the effects of your novel treatment unable to be captured by standard assessments?
Let MMI provide insights into your clinical study imaging.
Have questions? We’ll connect you immediately to one of our scientific managers and imaging experts. Your time is precious, and we want to make the most out of it.
