Case Study
Case Study
Large-Scale Comparative Study for Cancer Screening for Label Expansion
600
K+patients
10
sites
87.5
Site Satisfaction Score (NPS)
3
years of follow-up
[✓] Submitted to and accepted by FDA
Client Challenges
To evaluate the clinical performance of a testing device for cervical cancer screening using RWD.
Study Type
Multi-center retrospective study
Data from Disparate Sources
Collect and integrate data from disparate sources to create a longitudinal patient record-extensive unstructured data including test results with comparator, biopsy details, pathology
OM1 Solution
1. Define Patient Cohort
Large, representative cohort of patients, receiving test with comparator cohort in non-inferiority design
2. Match Sites and Patients
Careful matching of sites as well as patients to ensure comparability
3. Validate Results
Extensive validation package and expanded indication
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