Our aim is to deliver clinically relevant evidence.
We provide solutions across the spectrum of AI product life cycle to our medical device and life science partners. The Digital CRO’s offerings include evidence and regulatory strategy, retrospective validation studies for use in CAD regulatory submissions and prospective assessment of clinical integration.
Robust, phased process
Vast data access
Assessment roadmap
Submission ready reports
Compliance with FDA, GCP and ISO requirements
Standalone model performance studies
Clinical reader (multiple reader multiple case) studies
Subspecialty radiologists for ground truth
Broad network of specialists for clinical readers
Shadow-mode | Performance assessment, failure mode analysis, clinical/technical feedback
Clinical workflow | Clinical utility assessment, user experience
Patient outcomes | Downstream care improvements, populational health, economic benefit analysis
Post-market surveillance | Performance monitoring over time, data harvesting for model finetuning
