Learn how a complex PMA study for the first noninvasive colorectal cancer screening test was successfully designed and executed, delivering faster timelines, high data integrity, and FDA approval.
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Key Highlights:
- 12,700+ patients enrolled
- 9,900+ evaluable samples
- 90 U.S. study sites
- Successful FDA approval
The Challenge:
Bringing a first-of-its-kind diagnostic test to market requires more than standard clinical execution. Precise measurement of sensitivity and specificity versus colonoscopy was essential. Additionally, this study faced critical hurdles:
- Low disease prevalence requiring large sample volumes
- Risk of patient non-compliance
- Tight regulatory expectations for PMA approval
- Managing complex diagnostic clinical trial logistics for home-based sample collection
What’s Inside the Case Study:
- The operational model used to manage a large PMA study
- Strategies for patient engagement, compliance, and optimized enrollment timelines
- Approaches to maintaining sample accountability
How did the study team successfully manage nearly 10,000 evaluable samples while supporting home-based collection and achieving FDA approval?
Download the full case study for a complete breakdown.
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