{"id":191,"date":"2019-09-13T18:28:25","date_gmt":"2019-09-13T18:28:25","guid":{"rendered":"https:\/\/ferriscan.com\/?page_id=191"},"modified":"2023-07-11T05:24:53","modified_gmt":"2023-07-11T05:24:53","slug":"ferriscan-for-pharma","status":"publish","type":"page","link":"https:\/\/ferriscan.com\/ferriscan-for-pharma\/","title":{"rendered":"FerriScan for Pharma"},"content":{"rendered":"\t\t
Resonance Health provides comprehensive clinical trial services for pharmaceutical companies using imaging end points in their Phase II, III, and IV clinical trials. A fully HIPAA, HITECH, and GDPR compliant web based infrastructure enables image data and results to be securely transferred from anywhere in the world to and from our core lab in Australia. Resonance Health has extensive experience and expertise in providing objective, reproducible, and quantitative imaging measurements and core laboratory services, and has provided these services for many clinical trials worldwide.\u00a0<\/p>
Resonance Health currently has 4 products with international regulatory clearances, including FerriScan, HepaFat-Scan, FerriSmart, and HepaFat-AI. In addition to core lab services, if clients require specialist reading services in other disciplines such as cardiology, Resonance Health is able to engage and manage fully audited and reputable third-party resources whenever necessary to provide a complete turnkey solution for clients seeking imaging CRO solutions.<\/p>
Our Gold Standard MRI technology (FerriScan) for liver iron concentration measurement alongside our Cardiac T2* MRI service has become established in many international \u2018Standards of Care\u2019 for Thalassemia and we have over a decade of expertise in this clinical indication, providing a meticulous, standardized and quality assured approach to a comprehensive range of imaging core lab services for pharmaceutical partners, researchers, and clinicians.\u00a0<\/p>
Resonance Health partners with many key stakeholders and prestigious organisations in the global hemoglobinopathy and metabolic disease clinical and patient communities, adding further value to our research partners who leverage our expertise, networks and close collaborations.<\/p>
Resonance Health\u2019s expertise in the provision of imaging core lab services for pharmaceutical company clinical trials has been used in many multinational, multicenter studies over 15 years. Imaging biomarkers are used in clinical studies providing a safe, non-invasive alternative to invasive procedures such as liver biopsy. Imaging provides an ideal solution where repeat measurements are required over the life of the study.\u00a0<\/p>
Resonance Health has been involved in clinical studies where our non-invasive measurements have been used to assist in:<\/p>
Our continually growing clinical network consists of primary and secondary care providers, key opinion leading clinicians and imaging centers worldwide.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t The Resonance Health team includes scientists, engineers, researchers, regulatory affairs expertise, and quality management. Our specially trained physicists and engineers are experts in image analysis using our patented world leading technologies, and are supported by the wider research and development team at the forefront of imaging analysis development. Resonance Health also partners with many other prestigious organisations, including government research bodies, universities, international patient organisations, and centres of excellence to develop and provide world leading solutions to the clinical and pharmaceutical communities.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t Resonance Health tightly controls standardisation of imaging data acquisition and processing.\u00a0 This is done using standardised acquisition protocols, the use of phantoms (sets of standards with known R2 or T2* values), and involvement from our team of physicists and engineers to liaise with sites at setup.\u00a0 Each MRI centre must submit phantom image data that meets the quality control requirements of Resonance Health for that product.\u00a0 Our team will liaise with each site to provide instructions for setup, troubleshooting, and assistance, and will confirm that the site is correctly set up for patient scanning (‘ verification’).\u00a0 Our team is highly experienced at liaising with and setting up sites remotely, with a 15 year history of doing so.\u00a0 Once our service team has determined that a scanner is correctly set up, trial subject scanning can begin.\u00a0 A patient participating in a clinical trial will be referred to a verified site for an MRI scan. The site will acquire data and upload the data to Resonance Health via our\u00a0 HIPAA, HITECH, and GDPR compliant ‘FAST’ system; a web-portal for the secure transmission of image data and patient results from anywhere in the world. Once received, the raw data is subject to stringent quality control checks, and if deemed suitable, is analysed. The results report is made available for download to authorised persons within a target turnaround time of two business days.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\tOverview of Services<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
Standardisation<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t