PHARMA SOLUTIONS
Cholestatic Liver Disease
Optimize day-to-day operations, navigate unforeseen complexities, and ensure regulatory compliance by leveraging our deep therapeutic knowledge and proven expertise in drug and biomarker development for cholestatic liver disease, including primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC).
Our Process
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Study process and documnet development with protocol design or review
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Sudy start-up, imaging center activation, standardization and training
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Imaging study management and continual site support
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Central image processing and reporting with quick turnaround time
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Secure data management with capture, cleaning, integration, tracking and communitcation
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Biostatistics for interim reviews and clinical study reports
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Study close-out, write-up and data archival
Quantitative Imaging Tools
Our extensive range of quantitative imaging tools delivered via a central imaging service provide a more comprehensive assessment of liver tissue for more objective and informed decision-making.
Clinical research opportunity
Leverage our smart imaging tools to optimize your clinical trial for more accurate participant screening, improved trial enrichment, and enhanced monitoring of cholestatic liver disease clinical trials. (5-8)
MRCP+ and LiverMultiScan metrics are accurate, reproducible, and standardized across MRI scanners for more robust and reliable data collection across multiple scanners and sites. (7, 13)
Accurate and reproducible metrics
MRCP+ and LiverMultiScan metrics are accurate, reproducible, and are standardized across MRI scanners for more robust and reliable data collection across multiple scanners and sites.(4,9)
An international imaging network
Perspectum’s international network comprises 500+ sites across the globe. We drive the integration of quantitative imaging in clinical research and improve imaging data quality to streamline logistics and reduce the cost of imaging in clinical trials.
Central Imaging Services
We receive raw images acquired by highly qualified and well-trained imaging center teams. All images are checked for quality, and every report undergoes a review process prior to return.
All images are uploaded to our secure, ISO 27001 and 21 CFR Part 11 compliant Perspectum Portal making study data and results available on a single platform with customizable access permissions.
References
1. Banerjee, R., et al. (2014). J Hepatol, 60(1), 69-77.
2. Pavlides, M., et al. (2016). J Hepatol, 64(2), 308-315.
3. Pavlides, M., et al. (2017). Liver Int, 37(7), 1065-1073.
4. Idilman, I. S., et al. (2013). Radiology, 267(3), 767–775.
5. Caussy, C., et al. (2018). Hepatology, 68(2), 763–772.
6. Wilman, H.R., et al. (2017). PLOS ONE, 12(2), e0172921.
7. Bachtiar, V., et al. (2019). PLOS ONE, 14(4), e0214921.
8. McDonald, N., et al. (2018). Sci Rep, 8(1), 9189.
9. Mayo R., et al. (2018). Hepatol Commun, 2(7), 807–20.
10. Wildman-Tobriner, B., et al. (2018). Gastroenterology, 155(5), 1428–1435.
11. Park, C. C., et al. (2017). Gastroenterology, 152(3), 598–607.
12. Jayaswal, A., et al. (2020). Liver International, 40(12), 3071-3082.
13. Dennis, A., et al. (2020). Scientific Reports, 10(1), 15308.
14. Imajo, K., et al. (2021). World Journal of Gastroenterology, 27(7), 609–623.
15. Dennis, A., et al. (2021). Frontiers in Endocrinology, 11, 575843.
16. Beyer, C., et al. (2021). Plos One, 16(4), e0249491.
17. Andersson, A., et al. (2021). Clinical Gastroenterology and Hepatology, S1542-3565(21)01056-9.
18. Harrison, S., et al. (2018). PloS One, 13(9), e0203054.
19. Harrison, S.A. et al. (2020). Journal of Hepatology, 71(4), 1198–1212.
20. Harrison, S.A., et al. (2021). The American Journal of Gastroenterology. 10.14309/ajg.0000000000001375
21. Langford, C.R., et al. (2021). Journal of Clinical Pathology. 75(2), 73–75.
These products and services are for investigational use only.