Advanced biostatistics methodology, for the medical devices of tomorrow.
oday’s medtech innovations, diagnostic devices, therapeutic technologies, AI-driven software, generate incredibly complex data. Yet, too often, the support infrastructure around that data feels rigid, siloed, or overly complicated.
Anatomise Biostats aims to be a different kind of partner. A grounded, adaptable team that speaks the specific language of medical devices and digital health, and focuses just as much on clear communication as it does on precise methodology.
“Our priority is to help medtech innovators translate complex data into clear, actionable insights that smooth the path from concept to patient care.” Who we are · Anatomise Biostats
Built for the people bringing medtech to market.
Our services are for those who want to bring cutting-edge medical devices and digital health solutions to market.
Medtech Start-ups & SMEs
Build evidence for regulatory approval and investor confidence without navigating the data alone.
Clinical & Biomedical Researchers
Enhance study design, data analysis, and reporting, enabling better-informed decisions and stronger outcomes.
Advisory & Legal Professionals
Support evidence-based cases with rigorous, transparent data assessments.
We understand the pressures you face, regulatory hurdles, tight timelines, and complex technologies.
Our role is to streamline this journey, reducing risks and helping you make meaningful progress towards patient benefit.
Your device deserves statistics that hold up.
A no-obligation conversation with a senior biostatistician. If we’re the right fit, we’ll prepare a complete proposal for the work, nothing is committed until the contract is signed.
Schedule a Discovery Call →Your dedicated, outsourced biometrics team.
Our role is to serve as your dedicated, outsourced biometrics team, providing customised support that includes a highly experienced lead biostatistician, statistical programmers, and full project management for the biometrics side of your clinical trial. We bring the expertise and continuity needed to guide your study from design through to analysis, managing each step with precision and ensuring insights are aligned with your project’s goals.
We take a multi-disciplinary approach and keep up-to date with the latest analysis techniques, such as Bayesian modelling and network analysis, so that we can provide the most comprehensive statistical services to suit evolving client needs.
Lead Biostatistician
Design · AnalysisHighly experienced leadership guiding your study from design through to analysis, with each step managed precisely.
Statistical Programmers
Datasets · CodeCustomised programming support producing analysis-ready datasets and reproducible outputs for your trial.
Full Project Management
Biometrics sideComplete project management for the biometrics side of your clinical trial, expertise and continuity throughout.
Clinical trials package
Our core clinical trials package covers essential biostatistics, quality control, and statistical programming for clinical trials. This means you have a dedicated and pre-vetted biostatistics team for your clinical trial, without the need to spend months recruiting and onboarding individuals. This is billed in six-month instalments to align with your project’s timeline.
Specialised extensions
Enhance your core package by adding specialised services such as bioinformatics or data science for £50,000 per annum. These can be selected based on your project’s unique needs.
A global service provider, headquartered in London.
London HQ
We are well versed in UK, EU, US, Australian and New Zealand regulatory requirements for medical devices and IVD, including AI and SaMD product requirements, with niche biostatistics expertise in evaluating these products.
The full biometrics scope, end to end.
Clinical Study Design
Protocols aligned with regulatory requirements, including power and sample size calculations.
SAPs (Statistical Analysis Plans)
Structured frameworks guiding data collection, analysis, and reporting, ensuring a well-documented approach to extracting meaningful insights.
Statistical Programming
Development of analysis-ready datasets and validated code to ensure reproducible, high-quality results.
Statistical Analysis, Simulation & Modelling
Thorough analyses and simulations informing reliable conclusions.
Reporting
Publication-ready reports presenting findings with clarity and precision.
Bioinformatics Support
Identification of patterns in high-dimensional data, integration of genomic or proteomic datasets, and merging of multiple data sources to uncover deeper insights.
Medtech-Focused Support
Assistance with pivotal trials, pilot studies, and related projects, tailored to unique objectives and timeframes.
Scoping Reviews, Meta-Analyses & Advanced Modelling
In-depth evaluations and strategic assessments enabling more informed decisions and forward-looking strategies.
Four reasons clients stay with us.
Designed for Medtech
We focus solely on the medical device and digital health space, understanding its unique challenges and requirements.
Modular Capabilities
Our flexible approach means you can tap into different skill sets, such as bioinformatics, data science, or RWE integration, as your project evolves. Access exactly what you need, when you need it.
Integrated Biometrics Team
Collaborate with a dedicated group of biostatisticians, bioinformaticians, and data scientists who feel like part of your own operation, not a distant vendor. Whether it’s standard analyses or complex pipelines, you get a unified, aligned approach that supports your objectives.
Clarity in Communication
Even when applying advanced methodologies, we prioritise clear interpretation and transparent reporting. Our goal is to ensure you fully understand your results and their implications.
Clarity, precision, adaptability.
At Anatomise Biostats, our philosophy is rooted in clarity, precision, and adaptability. We understand that medical technology is advancing rapidly, creating new challenges and opportunities for clinical research. In response, we take a modern, dynamic approach to biostatistics, delivering reliable data analysis that supports confident decision-making and efficient regulatory approvals.
We adopt a streamlined, modular approach to biostatistical services. This flexibility allows us to tailor support to the unique needs of each project, whether it involves diagnostic devices, therapeutic technologies, AI-driven software, or aesthetic innovations.
Our focus is on simplifying collaboration and ensuring high-quality outcomes without unnecessary complexity.
We take pride in contributing to medtech research that upholds the highest standards of integrity.
“By handling every dataset with care and precision, we help build a solid foundation for the innovations of tomorrow.”
Ready to get started?
Don’t let data be the bottleneck of your breakthrough. Let’s have an honest conversation about your upcoming trial and find the most direct path to your goals.
Schedule a Discovery Call →A Note from the Managing Director
When Anatomise Biostats began, the aim was clear: to give medtech innovators the clarity and confidence needed to navigate complex trial data, helping their breakthroughs move closer to patient care. The landscape of medical innovation is evolving rapidly, and it can be challenging to proceed without reliable insights at hand. By working closely with clients, listening to what’s needed and responding with adaptable, straightforward services, my hope is that we help build trust and make each step of the trial process feel more manageable.
In shaping our approach, I’ve focused on creating an environment where collaboration is streamlined, communication is open, and data is handled with care. This means offering modular services that grow with your project and providing support that feels truly integrated into your team. It also means encouraging honest conversations from day one, so we can find the most direct path to your goals.
As we continue to evolve, I remain committed to supporting medtech innovation with sincerity, precision, and a readiness to adapt. It’s my belief that when complex analysis is made clear, good decisions follow, and that is ultimately what helps the entire sector move forward with confidence.
ISO 27001 ISO 9001 certified
ISO 27001 ISO 9001 certified
Ready to get started?
Don’t let data be the bottleneck of your breakthrough. Let’s have an honest conversation about your upcoming trial and find the most direct path to your goals.
Schedule a Discovery Call