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 Specialists
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.
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.
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.
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.
English