Intrinsic Imaging has the most comprehensive and sophisticated quality management system in the industry. Our quality management system is FDA audited, ISO 9001, ISO 13485, ISO 22301 and ISO 27001 certified and GAMP® 5 compliant.
Throughout each clinical trial, Intrinsic Imaging processes all images received from imaging sites.
To do so, we implement technology to allow the electronic transfer of images from imaging sites directly into Intrinsic Imaging’s central cloud repository. After training, each imaging site is provided access to the system. Sites do not need to install software on their desktops nor configure firewalls.
Once images are uploaded, our system automatically sends a message to the project team in real time allowing for the immediate tracking of which images are received from which site.
At Intrinsic Imaging, the processing of patient timepoints received from sites is meticulously planned, implemented and monitored for success.
Whether the images received are in support of a Phase I-IV clinical trial or Class I,II or III medical device trial, our team has the expertise and experience.
For every clinical trial, Intrinsic Imaging prepares an Image Processing Manual. This Image Processing Manual describes the exact procedure to be used to process images to ensure success.
Quality Control & Site Queries
Intrinsic Imaging reviews and quality controls all images within 24 hours of receipt for the entire duration of the clinical trial.
This immediate quality control of the images allows the determination if the image has been acquired correctly. It also enables the immediate query of the site if deemed necessary.
Further, immediate quality control enables us to provide feedback to the site to prevent further images from being acquired incorrectly. Though rarely needed, it also enables the site to re-image the patient within the acceptable time-frame for that timepoint if required.