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.

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

Publications

Data Management in Artificial Intelligence-Assisted Radiology Reporting

Bizzo BC, Almeida RR, Alkasab TK.

J Am Coll Radiol. 2021 Nov;18(11):1485-1488. doi: 10.1016/j.jacr.2021.09.017. Epub 2021 Oct 6. PMID: 34624236

Lessons Learned From the Front Lines of Artificial Intelligence Implementation

Alkasab TK, Bizzo BC.

J Am Coll Radiol. 2021 Nov;18(11):1474-1475. doi: 10.1016/j.jacr.2021.09.019. Epub 2021 Oct 9. PMID: 34637776

Artificial Intelligence Enabling Radiology Reporting

Bizzo BC, Almeida RR, Alkasab TK.

Radiol Clin North Am. 2021 Nov;59(6):1045-1052. doi: 10.1016/j.rcl.2021.07.004. PMID: 34689872

Development and Clinical Application of a Deep Learning Model to Identify Acute Infarct on Magnetic Resonance Imaging

Bridge, C.P., Bizzo, B.C., Hillis, J.M. et al.

Sci Rep 12, 2154 (2022)

FDA-Regulated AI Algorithms: Trends, Strengths, and Gaps of Validation Studies

Ebrahimian S, Kalra MK, Agarwal S, Bizzo BC, Elkholy M, Wald C, Allen B, Dreyer KJ.

Acad Radiol. 2021 Dec 27:S1076-6332(21)00415-3. doi: 10.1016/j.acra.2021.09.002. Epub ahead of print. PMID: 34969610

All Publications