Efficient and scalable delivery – Scaling up imaging solutions for global, multicentre, interventional trials
We are often asked to scale up our imaging solutions for global, multicentre, interventional trials. For these types of trials in the later stages of drug development, the challenge is to detect longitudinal changes with an imaging method that is both stable and reproducible over a long period of time across a large variety of scanner models.
Maintaining quality in the longest ever interventional MRI-PDFF trial
One example of this is when we used our high precision Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) approach for an international, multicentre trial evaluating the long-term effects of a specific therapy for type 2 diabetes. The imaging approach could successfully show a >30% reduction in liver fat that was maintained over 122 weeks. The clinical trial is the longest randomized, interventional trial with MRI-PDFF ever performed (Frías et al. Diabetes Obes Metab. 2021).
Success factors for scaling up our imaging solutions
Our success in running large, multicentre trials is due to several unique factors:
Flexible global imaging site selection
- We have a large and growing, global imaging site network (currently around 400 imaging sites) ready to participate in international, multicentre trials. And where we do not have imaging sites up and running, our experienced and skilled imaging experts can efficiently set-up, train, and qualify new imaging sites across the globe.
- We aim to harmonise imaging protocols across scanners, those of all leading manufacturers and with variable field strengths, allowing us to be flexible with imaging sites without compromising on quality.
Maintaining high quality throughout a trial
- Optimal imaging site performance and high-quality image acquisition is ensured by continuous contact and feedback from our image analysis CoreLab to the imaging sites.
- Our global team of imaging experts retrain imaging site staff when necessary, which is especially important for trials of long duration during which staff and imaging hardware may change.
Efficient management and delivery from our CoreLab
- With our competent and certified image analysts at our CoreLab, we can ensure rapid quality control feedback to imaging sites, often within 24 hours, to correct any deviations from image acquisition guidelines.
- When imaging data are part of the screening process, our highly efficient analysis workflows enable fast turnaround times to avoid any delays in subject randomisation.
- Our CoreLab analysts performs central analysis of all defined imaging endpoints, and the full results data set is always delivered timely after the final patient visit.
Our people – the foundation of everything we do
- Our global team of imaging experts provide almost 400 years of accumulated experience in imaging. They know what it really takes to make imaging work in large-scale settings.
- Clinical trials are never the same, and our CoreLab image analysts combine their competence in image analysis within specific disease areas with great teamwork to deliver high-quality and timely results in every trial.
- Our experienced project managers put themselves in the shoes of our customers, ensuring true partnership and understanding throughout a project.
- Read more about our people here.