Digital Clinical Research Organization

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.

Why choose 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

Offerings and capabilities

Validation and regulatory clearance

• Pre-submission (Q-Sub)
• Pilot and pivotal study design
• Scientific publication roadmap
• Clinical implementation strategy
• Human factors (usability) assessment

Deployment and clinical integration

• Standalone performance assessment
• Image processing/quantification
  • CADt (triage)
  • CADe (detection)
  • CADx (diagnosis)
• Clinical reader study (CADe, CADx)

Real-world monitoring

• Ground truth and reads by U.S. board certified sub-specialty physicians
• Shadow-mode ‘real-world’ performance analysis
• Clinical workflow impact assessment
• Patient outcome and economic benefit
• Monitoring and post-market surveillance with potential for product enhancement
• Usability and human factors testing