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Data Science Office

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CRO

Digital Clinical Research Organization (CRO)

Medical and AI expert partner to generate clinically relevant evidence for regulated SaMD products from concept to clinical adoption

Why us?

Direct experience and access to clinical and image based diagnostic workflows

Deep expertise in validation planning, study design and conduct

Optimal conveyance of product performance to regulators and users

Clinical Relevance

Product Performance Assessment

Standalone model performance studies

Clinical reader (multiple reader multiple case) studies

Subspecialty radiologists for ground truth

Range of specialists for clinical readers

Strategy Validation Planning

Robust, phased process

Vast data access

Assessment roadmap

Submission ready reports

Compliance with FDA, GCP and ISO requirements

User Experience Clinical Workflow Integration

Model deployment in clinical and ‘shadow’ environments

Clinical advice on workflow integration

Categories of projects

Support of FDA submissions including CAD devices

Clinical validation studies

Clinical product adoption

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