Global Clinical Trial Solutions for BioPharma and CROs
Resonance Health offers post-imaging software that allows for standardised analysis across multiple clinical trial sites. Our core products have regulatory clearances, including FDA and CE-mark, enabling simplified, non-invasive metabolic and liver-related assessments. Turnaround time is quick and data is standardised across all sites.
Importantly, our service is MRI-agnostic, allowing radiology centres to use their own scanners and procedures, with minimal disruption or trial-specific training required.
Service Offering for Clinical Trial Sponsors
With access to a vast network of Australian and global radiology sites, third party vendors and a secure image data portal, we can provide quality-assured imaging analysis services for clinical trials. As an imaging CRO, our services include:
- Detailed, comprehensive proposal
- Dedicated project management support
- Site set-up
- fast registration of site’s chosen radiology centre
- rigorous verification process includes a test scan prior to first patient visit, using phantoms manufactured by Resonance Health
- Development of imaging charter
- Clinical reports – secure, accurate and timely
- Data Transfer Agreement for electronic data transfer, either in our default or client-specified format
- GCP and 21 CFR Part 11 compliance
- ISO 13485 accredited
