Data Science Office

Digital CRO

Digital Clinical Research Organization (CRO)

Our aim is to deliver clinically relevant evidence.

From concept to market adoption, we offer Medical and AI expertise to generate clinically relevant evidence for regulated Software as a Medical Device (SaMD) products.

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

Track record of successful FDA clearance studies

Clinical Relevance

Validation & Regulatory Clearance

Pre-submission (Q-Sub)

Pilot and pivotal study design

Scientific publication roadmap

Clinical implementation strategy

Human factors (usability) assessment

Deployment & Clinical Integration

Standalone performance assessment

Image processing/quantification

  • CADt (triage)
  • CADe (detection)
  • CADx (diagnosis)

Clinical reader study (CADe, CADx)

Ground truth and reads by US board certified sub-specialty physicians

Real-World Monitoring

Shadow-mode ‘real-world’ performance analysis

Clinical workflow impact assessment

Patient outcome and economic benefit

Monitoring & post-market surveillance with potential for product enhancement

Usability and human factors testing


All Publications

© 2023 Mass General Brigham Incorporated. All Rights Reserved