About the Camera
Our highly qualified project team works closely with the Sponsor clinical personnel to develop a ‘photography approach’ adapted to your specific trial needs and we develop a tailored image procedure document to clearly determine which imaging systems are to be used, camera settings, lighting conditions, image acquisition / transmission steps, etc. The goal is to provide specific guidelines to ensure reproducible images / data for a given center and between multiple centers.
Regular communication is particularly critical in the set-up phase of the study. We organize regular team meeting both internally and with Sponsor staff to ensure roles and responsibilities are clear and timelines are respected.
Training & Site Qualification
The training of the clinical sites are critical to the success of the imaging portion of a trial. Site staff can either be trained at an Investigator meeting, via a webinar or on-site regarding all procedures. Once the training is complete, each site performs a qualification procedure where test subject images are transferred and processed to ensure the site personnel’s comprehension of the image procedure. Only after the site has been ‘qualified,’ are they permitted to enter real subject images and data.