Biostatistics and bioinformatics for medical device, IVD, and digital health sponsors who need regulatory-grade evidence without the overhead of a full-service CRO.
Company Profile
A biostatistics and bioinformatics CRO working principally with medical device, diagnostic, and digital health companies.
Senior team of statisticians, programmers, and bioinformaticians who scope the work and then deliver it. No junior handoffs. Early-stage and mid-size sponsors get the same practitioners that large CROs reserve for enterprise accounts.
Evidence packages are built for multi-market submission: MHRA, TGA, Medsafe, and FDA, with statistical analysis plans, datasets, and reports prepared to ISO 14155, MDR/IVDR, and CDISC standards.
Key differentiators
Direct access to senior statisticians
No junior analysts. You work with the same biostatisticians from first call to final submission.
MedTech-only focus
Unlike generalist CROs, every project here is a device, diagnostic, or digital health study. The regulatory context is assumed.
Multi-market regulatory coverage
Expertise in United Kingdom, European, Australian, New Zealand, and United States regulatory submissions.
Expertise
Diagnostic Devices
Sensitivity, specificity, and ROC analysis; analytical and clinical validation for diagnostics and biomarker programmes.
Therapeutic Devices
Efficacy and safety endpoints, longitudinal analysis, and evidence packages for regulatory submission.
SaMD & AIaMD
Algorithm validation, calibration, and performance benchmarking for software and AI-based medical devices, with experience across diagnostic, prognostic, and monitoring applications.
Aesthetic Medicine
Efficacy, safety, and patient-reported outcome evidence to support product claims.
Core Services
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Advanced biostatistical design and analysis
Sample size and power, adaptive and performance-goal designs, statistical analysis plans, and reporting aligned to ISO 14155, MDR/IVDR, and FDA requirements. Bayesian methods and master protocols where appropriate.
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Bioinformatics
Data mining, signal processing, and machine learning applied to clinical and device data.
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Statistical programming
R and SAS programming, data management, CDISC-compliant SDTM/ADaM dataset creation, and analysis automation.
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Algorithm and software validation
Validation strategies for SaMD and AIaMD, including reader studies, reference standard definition, and generalisability assessment.
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Diagnostic performance studies
Sensitivity and specificity estimation, agreement studies, and analytical validation for IVD and companion diagnostic programmes.
Regulatory alignment
Statistical analysis plans, datasets, and reports are prepared to the standards expected by:
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United Kingdom
MHRA Medicines and Healthcare products Regulatory Agency
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Europe
MDR / IVDR European medical device and IVD regulations
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Australia
TGA Therapeutic Goods Administration
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New Zealand
Medsafe Medicines and Medical Devices Safety Authority
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United States
FDA 510(k), De Novo, and PMA pathways
Industry Recognition
Biotechnology Consultancy Firm of the Year 2026/27
Biotechnology Consultancy Firm of the Year 2025/26
CorporateLiveWire Global Awards 2024/25 Winner
Best Bioinformatic & Biostatistical Consultancy Firm 2024, UK
Medical Device Start-Up Consultancy of the Year 2024, England
CorporateLiveWire Global Awards 2023/24 Winner
Best Medical Device Start-Up Consultancy 2023, South East England
English