Data Science Office

Digital CRO

Digital Clinical Research Organization (CRO)

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.

Two physicians looking at x-ray images

Why us?

Direct experience and access to clinical and image based diagnostic workflows

Deep expertise in validation study planning, design, conduct and reporting

Optimal conveyance of product performance to regulators and users

Clinical Relevance

Strategy / Validation Planning

Robust, phased process

Vast data access

Assessment roadmap

Submission ready reports

Compliance with FDA, GCP and ISO requirements

Product Performance Assessment

Standalone model performance studies

Clinical reader (multiple reader multiple case) studies

Subspecialty radiologists for ground truth

Broad network of specialists for clinical readers

User Experience Clinical Workflow Integration

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

Publications

All Publications

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