From Data to Decisions > Biostatistics You Can Trust
At Anatomise Biostats, we specialise in delivering tailored biostatistical consulting services for med-tech start-ups and SMEs.
We help accelerate your path to market, streamline clinical trials in line with regulatory requirements, and maximise cost-efficiency. Our solutions are designed to enhance your data-driven decision-making process, supporting you at every stage of therapeutic development.
Partner with us to transform your clinical data into actionable insights and drive innovation in healthcare. Get in touch today to learn how we can help your next project succeed.
Your Biometrics Team for Medtech Clinical Trials
Biostatistics
Biostatistics expertise specific to medtech clinical trials from efficient study design and protocol development, advanced statistical analysis and modelling, to actionable reporting.
Bioinformatics
Bioinformatics 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.
Statistical Programming
Statistical programming in R or SAS for data cleaning, CDISC-compliant dataset creation, & analysis automation, enabling accurate, reproducible results and smooth regulatory submissions.
Sectors
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.
We assist therapeutic and diagnostic device start-ups and SMSEs 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.
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.
Process to get started
- Reach Out for Your Free Consultation
Share your study details with us to schedule a consultation. We’ll discuss your goals, needs, and the scope of your project, ensuring we understand exactly how to support your clinical study.
- Receive a Tailored Proposal and Quote
Based on your study requirements, we provide a detailed proposal outlining our approach, timeline, and costs. This transparent quote allows you to see the full value of our services.
- Rapid Onboarding with Your Dedicated Biostatistics Team
Once approved, we move quickly into action. A lead biostatistician is assigned to oversee your project, and your bespoke biostatistics team is ready to get to work—whether it’s developing an SAP, auditing an existing study design, or addressing your specific biostatistical needs.
What to Expect with Our Biostatistics Support for Clinical Trials
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 and 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 and Interim Analysis
Planned analyses at key interim points to guide study adjustments based on emerging data and make decisions where appropriate.
Final Data Analysis and 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 and Regulatory Meetings
Availability for sponsor clinical team and regulatory meetings to ensure alignment and support throughout the trial.