Biostatistics CROs with focused AI / SaMD and Hybrid Device Experience

These CROs specialize in software as a medical device (SaMD), AI/ML validation, and hybrid device–software trials, offering algorithm performance testing, real-world data studies, and specialized statistical methods.

AI / SaMD / Hybrid

Anatomise Biostats (UK / Australia)

Biostatistics & Bioinformatics consultancy, MedTech-focused, Boutique.

Designs algorithm validation studies and performance-goal analyses for SaMD, leveraging both clinical and real-world data. Provides tailored statistical programming and reporting for hybrid device–software products.

MCRA – Digital Health CRO (USA)

Full-service CRO, MedTech-focused, Mid-Tier.

Designs and executes SaMD clinical programs, from pilot algorithm testing to pivotal validation studies. Integrates biometrics and regulatory strategy for FDA’s Digital Health guidance and EU MDR software annex.

RQM+ (USA)

Full-service CRO, MedTech-focused, Mid-Tier.

Conducts clinical trials for AI/ML-based devices, focusing on algorithm accuracy and safety endpoints. Offers quality and regulatory services to navigate SaMD collections and submissions.

Veranex (USA)

Full-service CRO, MedTech-focused, Mid-Tier.

Offers site feasibility, monitoring, and statistical analysis for software-driven devices and AI algorithms. Supports global submissions for SaMD under FDA, EU MDR, and other digital health frameworks.