Anatomise Biostats

Anatomise Biostats is a specialized service provider offering end-to-end biometrics support for clinical trials in the med-tech sector, particularly for start-ups and SMEs. Its core value proposition lies in delivering flexible, fully-managed biostatistics and data science services to accelerate regulatory approval and market entry for diagnostic devices, therapeutic devices, Software as a Medical Device (SaMD), and aesthetic medicine products. The company operates on a transparent, project-based consulting model, aiming to be a cost-effective alternative to building an in-house biometrics team. Its focus on niche, complex areas like AI/ML-driven diagnostics positions it within the growing convergence of biotech, data science, and digital health.

Integrated service offering combining biostatistics, bioinformatics/machine learning, and statistical programming (R/SAS) for clinical trial design, analysis, and regulatory submission support, with a focus on CDISC standards.

Competes with large, full-service global Contract Research Organizations (CROs) that offer biometrics as part of a broader package, as well as other niche biostatistics consulting firms. Differentiation is based on deep specialization in med-tech, SaMD/AIaMD, flexible engagement models, and a focus on the unique needs of start-ups and SMEs.