Setting-up for success: our approach to imaging site set-ups

Imaging can provide a lot of value to a drug development program, often delivering insights that cannot be obtained another way. Unlike in clinical practice, imaging in clinical trials is used to help measure treatment efficacy at a group level. To have confidence in the insights from the imaging in a clinical trial, there needs to be consistency with how the imaging is performed across scanners and sites. This requires both tailored site set-up and proactive site management, processes that can be often overlooked, yet will have a direct and meaningful impact on the quality of the imaging data and the reliability of the results.

At Antaros Medical, our approach to site set-up and management reflects our understanding of their importance to the overall success of a clinical trial. We believe that thoughtful selection, efficient training and proactive communication are key to ensuring quality imaging data. Our site set-ups are:

Tailored to meet the requirements of the study and the individual site

We have an extensive and growing global imaging site network (currently at ~450 imaging sites), but no imaging sites are the same. The site qualification, set-up and training processes need to be tailored to the specifics of the study (i.e. imaging endpoints) and the specifics of the site (i.e. number of technicians, site experience, or different scanners).

Where we do not already have imaging sites up and running, our imaging experts can efficiently qualify and train new imaging sites. Over time we have streamlined our site qualification process so that it is thorough, but also straightforward and less resource-intensive for the site:

Our training material is constantly being improved and our expertise allows us to efficiently deliver trainings as we know exactly what needs to be covered and how best to do this. Whether this is through group trainings, 1-to-1s, self-trainings or organised Q&A sessions, our team propose and advise which training formats will be most suitable for each individual site.

Conducted by flexible and dedicated imaging experts

Our people are the foundation of everything that we do. The key to our success with site set-ups is our flexible and dedicated team. Our imaging specialists have the technical expertise and hands-on experience from having worked at imaging sites which enables them to communicate effectively with the sites – they are ‘speaking the same language’, if you will. They are also spread out across the world and can cover a variety of geographies and time zones.

Throughout our trials, imaging sites are assigned a dedicated specialist with imaging and technical expertise. Our imaging specialists serve as a point of contact throughout the trial and are therefore able to build a relationship with the site. The feedback we often get from sites is that this is really appreciated.

Focused on quality and scientific excellence

Ensuring and maintaining quality and scientific excellence throughout clinical trials is essential. And we believe they work together. For example, if a site does not have experience with certain imaging endpoints, it can sometimes be challenging for them to understand why the imaging needs to be done differently that it is in clinical practice. If you explain why this makes a difference, from a scientific perspective, it is more likely to click. We often receive positive feedback from staff at the imaging sites saying that they are learning more about the science behind the imaging, and further developing their technical skills while working in our trials.

Sometimes things do not go exactly to plan. On occasion, images do not pass quality control or are not uploaded correctly by the site. In these instances, if feedback and communication alone are not sufficient to resolve the issue, it can be necessary to retrain the site and may involve on-site visits. This is always handled on a case-by-case basis and in consultation with the study sponsor.