Clinical Research Imaging Systems and Tips

July 7, 2015

Clinical research imaging has become an important tool in documenting a product or treatments performance in clinical trials.  It can serve as another line of evidence to support claims and study data, and is useful in communicating results from the study, especially when combined with image analysis.   Many of our clients have given us compliments on the quality of our images and we would like to share our top 10 tips on how to produce high quality images that can be helpful if you are taking them in-house or what to look for when qualifying a site for a study.

The overall key is to success in any imaging workflow is to maintain tight control over the imaging system and procedures.

  1. Choose the right camera and set up based on the goals of the study. There are many different options for imaging systems.  The more well-known one in the clinical research area are the Canfield Systems, but there are many other options, such as custom setups like the Stephens Imaging System or the Hirox KH-1300, that JRC just acquired, which is useful to capture up close images of pores and dry skin.  At Stephens, we provide a wide variety of imaging systems for our clients to accommodate any needs they may have.  If we don’t own it, then we look into renting it.
  2. Select the right lighting conditions. The most common options in the research area are macro, visible light, cross-polarized light, raking light, UV reflectance, and UV fluorescence and which one to use depends upon the study objectives. For example, if a sponsor wished to highlight the texture on a panelist’s cheek, then we would recommend a raking light design where the cheek is illuminated at a grazing angle. The sharp angle of light causes the texture on the cheek to cast small shadows, emphasizing wrinkles, acne scars, or other desired features.  Each piece of equipment varies on the lighting options available as well.
  3. Maintain consistent color and exposure by using a color checker.
  4. Note taking and documentation! Document the lighting and camera settings, positioning notes, and other crucial data to ensure consistency during the project accurate reproduction at a later date. Refer to the standards throughout the study.  It’s critical to document exposure control, white balance, evenness of illumination, depth of field, and lens selection.
  5. Ensure the position of the subject is consistent from visit to visit. This is by far the most challenging element to control.  At Stephens, we use software that allows us to overlay a live video of the panelist over a baseline photograph to help us position the panelist as they were in their baseline visit.  We also set up our cameras and rigs to minimize the amount a panelist has to move.
  6. Capture images as RAW files and re-save as JPEGs. The RAW files will allow you to do analysis on the images and JPEGs are quicker and easier to view on a computer.
  7. Quality Equipment! Make sure the equipment is in good condition and kept calibrated, when needed.
  8. Training of staff on how to use the equipment.
  9. Have written procedures (SOPs) and Work Instructions that detail the operations, processes and practices that should be followed to make sure everyone is aligned.
  10. Finally, communication! From a site stand point, we need to know what your expectations are and how you plan on using these photos.  From there, we can help make sure we select the right piece of equipment, lighting condition, set up and delivery method.

We believe that this attention to detail allows us to produce consistent images from the first visit to the last and gives us an air of professionalism that our clients have come to admire.  Please contact us to learn more about imaging for clinical trials and our imaging options.