Recognition
Turn Medtech Innovation into a tangible benefit to patients with Biostatistics you can trust.
Accelerate your product’s path to market with streamlined clinical trials that align to regulatory requirements and maximise cost-efficiency.
At Anatomise Biostats we specialise in delivering tailored biostatistical services to med-tech start-ups and SMEs — the calibre of biometrics usually reserved for the largest sponsors, without the minimum-spend.
Schedule a discovery call — a no-obligation conversation with a senior biostatistician about your study. If we’re a fit, we’ll follow it with a detailed written proposal: scope, timeline, costs, and our quality and data-security standards.
Clinical evidence · Made clearYour Biometrics Team for Medtech Clinical Trials
Three disciplines, one integrated team — designed around the evidence needs of medical device and digital health development.
Biostatistics expertise specific to medtech clinical trials from efficient study design and protocol development, advanced statistical analysis and modelling, to actionable reporting.
Explore biostatisticsBioinformatics approaches such as data mining, signal processing, and machine learning, enabling comprehensive analysis of clinical and device data for optimised device performance and patient care insights.
Explore bioinformaticsStatistical programming in R or SAS for data cleaning, CDISC-compliant dataset creation, & analysis automation, enabling accurate, reproducible results and smooth regulatory submissions.
Explore programmingSectors
Specialist statistical support across the device landscape — from first-in-human diagnostics to AI-driven software.
Diagnostic Devices
Sensitivity, specificity, ROC analysis; reliable diagnostics meeting clinical and regulatory standards. Biomarker discovery for advanced diagnostic development, including liquid biopsy.
→Therapeutic Devices
Efficacy, safety assessments; endpoint and longitudinal data for regulatory approval. Robust evidence supporting therapeutic benefits across varied patient populations.
→SaMD & AIaMD
Algorithm validation, calibration, performance benchmarking; consistent, reliable outcomes for software and AI-driven devices. Assurance of compliance and clinical relevance for digital health solutions.
→Aesthetic Medicine
Efficacy, safety, patient-reported outcomes; evidence for product claims in aesthetics. Data that supports market positioning and patient satisfaction.
→Benefits of Outsourcing With Us.
Fully-Managed Biometrics
Fully managed biometrics support for your clinical trial with a bespoke team of clinical data experts. We handle IT infrastructure and project management to keep workflows smooth and collaboration easy.
Flexible, Scalable Support
Biometrics support that adapts as your trial needs change. This approach is ideal for smaller companies and start-ups, helping you avoid the costs and challenges of building and maintaining an in-house technical team.
Transparent, Modular Pricing
Our transparent pricing model gives you a clear view of costs from the start, allowing you to budget confidently without hidden fees or surprises.
We assist therapeutic and diagnostic device start-ups and SMEs in achieving regulatory approval goals through efficient study design. Our precise insights ensure products meet safety standards and reach the marketplace cost-effectively — benefiting both shareholders and consumers. By addressing niche and complex projects, such as SaMD, we aspire to improved patient outcomes and advancements in medical technologies.
How engagement works
Schedule a Discovery Call
A no-obligation conversation with a senior biostatistician about your device, evidence gaps and regulatory pathway — so we understand exactly what your study needs.
We Review Your Documents
Protocol, objectives, prior data or regulator feedback — we assess what your project actually requires before anything is priced or proposed.
You Receive a Full Proposal
The recommended scope of work, itemised costs and timeline, plus the quality and data-security standards we’d apply. The work order is shaped with you and signed only once the contract is agreed.
What to Expect with Our Biostatistics Support for Clinical Trials
A complete biometrics workstream — every deliverable your study needs, from first protocol to final submission.
Fully-managed Biometrics Team
A dedicated biometrics team tailored to your study’s needs, providing full support across biostatistics, statistical programming, QC, and project management.
Clinical Study Design
Full study design and planning for your project, including sample size simulations, randomisation schedule, and protocol setup.
Statistical Analysis Plan (SAP)
A detailed SAP outlining study design, all statistical methods and analysis requirements, and data considerations for the study.
Data Consulting
Advice on data collection strategies with methods integrated into the protocol and SAP. Availability for DMC meetings.
Statistical Programming & CDISC-Compliant Data Sets
Creation of CDISC-compliant data sets, comprehensive statistical programming, and dataset validation to meet regulatory standards.
Stringent Quality Control
Independent QC procedures across all outputs and deliverables, including SAPs, data sets, TLFs, statistical analyses, and SARs, to ensure accuracy, consistency, and compliance with regulatory standards.
Adaptive Trial Design & Interim Analysis
Planned analyses at key interim points to guide study adjustments based on emerging data and make decisions where appropriate.
Final Data Analysis & Reporting
Comprehensive final analysis of study results with structured reports and TLFs that present findings clearly and accurately.
Regulatory-Ready Deliverables
Complete documentation packages prepared for regulatory submission, ensuring compliance and ease of review.
Sponsor & Regulatory Meetings
Availability for sponsor clinical team and regulatory meetings to ensure alignment and support throughout the trial.
Ready to turn your clinical data into a regulatory success?
Your med-tech innovation has the potential to change patients’ lives. Don’t let complex statistics slow down your path to market. Schedule a discovery call — a no-obligation conversation with a senior biostatistician, followed by a detailed written proposal if we’re the right fit.