Biostatistics and Statistical Programming Services for Clinical Trials
Anatomise Biostats offers comprehensive, end-to-end biostatistical support tailored to the unique demands of medtech clinical trials. Our dedicated biometrics team combines expertise in study design, data management, advanced statistical methods, and regulatory support, guiding your device through every phase of validation and regulatory submission. Whether your focus is diagnostics, therapeutic devices, SaMD, or aesthetic medicine, our services ensure that your data is precise, compliant, and ready for review.
We work with CROs to deliver advanced statistical services on such projects. We can combine our statistical knowledge with bioinformatics capabilities to design and analyse biomarker-guided clinical trials and exploratory studies.
For more information on the ways we can assist in clinical trials and statistical analysis in general, please see below.
Complete Biostatistics and programming for Medtech Clinical Trials
Biostatistical Services for Medtech Clinical Trials
Our approach to clinical trials encompasses every stage, providing the precision, flexibility, and support needed to navigate the medtech regulatory landscape.
Fully-Managed Biometrics Team
A successful clinical trial requires a collaborative team with expertise in medtech. Anatomise Biostats provides a fully-managed biometrics team tailored to your study’s needs, covering biostatistics, statistical programming, quality control, and project management. Your outsourced biometrics team works as an integrated unit, offering continuity and a seamless experience from planning to final submission. With dedicated professionals assigned to each aspect of biostatistics, we ensure high standards in data analysis, consistency across outputs, and clear communication with sponsor teams.
Comprehensive Clinical Study Design
Our clinical study design services cover every foundational element required to set your trial up for success. We conduct sample size calculations and simulations that are fine-tuned for medtech, addressing device-specific variability and regulatory expectations. Randomisation schedules are carefully designed to reduce bias, and our team develops complete protocols that define endpoints, data collection methods, and analysis timelines. Each plan we design aligns with the scientific and regulatory standards critical to medtech submissions.
Detailed Statistical Analysis Plan (SAP)
An SAP is crucial for establishing how data will be analysed and interpreted, and our approach leaves no aspect unaddressed. Each SAP includes a comprehensive outline of study design, statistical methods, data handling, and analysis requirements. We account for unique medtech study considerations, such as repeated measures or specific validation endpoints. Every SAP is crafted to enhance clarity, reduce regulatory questions, and ensure that results are scientifically sound and legally compliant.
Specialised Data Consulting
In medtech trials, data integrity and method consistency are vital. Our consulting services provide expert guidance on data collection strategies, which are fully integrated into the study’s protocol and SAP to optimise efficiency and accuracy. We advise on methods tailored to device performance metrics, ensuring that data supports trial objectives. Our consultants are available for Data Monitoring Committee (DMC) meetings, offering ongoing insights that can support trial adjustments or decision points when needed.
Advanced Statistical Programming and CDISC-Compliant Data Sets
Our programming team creates robust, regulatory-compliant datasets using CDISC standards, ensuring seamless integration with regulatory bodies’ data requirements. We deliver datasets and derived variables tailored to your device’s needs, alongside comprehensive validation to verify accuracy. Our expertise in handling complex datasets, such as those involving time-series data from devices or complex algorithms in SaMD, ensures every data point is both meaningful and compliant.
Stringent Quality Control (QC)
Quality control is at the heart of every deliverable we produce. Our independent QC procedures span all outputs, including SAPs, datasets, tables, listings, figures (TLFs), statistical analyses, and summary analysis reports (SARs). We follow rigorous protocols to cross-check for accuracy, consistency, and compliance, reducing the risk of discrepancies or regulatory delays. Our QC team operates independently of the analysis team, ensuring objectivity in review processes and maintaining regulatory standards.
Adaptive Trial Design and Interim Analysis
For medtech trials, especially those involving iterative devices, adaptability is often essential. Our adaptive trial design services offer planned interim analyses at strategic points, allowing you to adjust study parameters based on real-time data without compromising trial integrity. By interpreting early indicators of device performance or safety, we enable data-driven adjustments that can enhance trial efficiency and optimise outcomes.
Comprehensive Final Data Analysis and Reporting
At the conclusion of your study, our team performs a complete data analysis, generating a set of reports that clearly convey study results. We create structured TLFs and a summary report that align with submission requirements and ensure all findings are presented with transparency and precision. Our reports are designed for usability, facilitating interpretation for sponsors, regulators, and other stakeholders involved in device approval.
Regulatory-Ready Deliverables
Regulatory submissions demand rigour and clarity. Our documentation packages are meticulously prepared to meet regulatory standards, with every deliverable fully documented and formatted for review. We produce submission-ready statistical analysis reports, annotated datasets, and all required supporting documentation, reducing the back-and-forth often required during regulatory review.
Ongoing Support in Sponsor and Regulatory Meetings
We offer ongoing availability to support sponsor and regulatory meetings, ensuring alignment and consistent communication throughout your trial. Our team attends regulatory discussions, contributing data insights, addressing any queries about statistical methods or findings, and assisting with clarifications to keep your trial moving forward without unnecessary delays.
A closer look at study design
We craft robust study designs tailored to medtech trials, ensuring each aspect aligns with your device’s unique objectives and regulatory requirements. Our approach combines clear endpoint definitions, optimal sample size calculations, and protocol development grounded in the latest statistical methods to enhance reliability and compliance across study sites.
- Defining Endpoints and Objectives
A strong trial begins with well-defined primary and secondary endpoints that align with regulatory goals and the device’s intended use. Our team collaborates with you to pinpoint the most relevant and measurable outcomes, whether assessing safety, efficacy, device performance, or diagnostic accuracy. - Sample Size Calculations and Power Analysis
Determining the appropriate sample size is essential to achieving statistically significant results. We conduct power analyses and sample size calculations tailored to your trial’s unique variables, accounting for anticipated effect sizes, patient variability, and the specific design requirements of medtech trials. - Protocol Development
Our protocol development integrates all aspects of the study design, including patient eligibility criteria, visit schedules, data collection methodologies, and endpoint definitions. The protocol is designed with clarity to support consistency across study sites and ensure compliance with regulatory standards. - Handling Missing Data
Medtech trials often encounter challenges with missing data, such as loss-to-follow-up. We address this proactively by incorporating the expectation of missing data into the trial design and adapting statistical analysis to account for it. By using strategies like multiple imputation, we ensure that missing data does not compromise the integrity or interpretability of your results. - Adjusting for Multiplicity
With multiple outcomes, subgroups, or treatment arms often present in medtech studies, multiplicity can become an issue. Our team designs and implements statistical adjustments to manage multiplicity, ensuring robust, interpretable results that maintain statistical validity across multiple comparisons and analyses. - Trial Simulation
We use trial simulations to evaluate and document the statistical properties of various design scenarios, helping you choose the optimal design for your device. Simulations allow us to anticipate trial dynamics, assess potential risks, and provide a data-driven foundation for selecting between different design options. - Customised Randomisation Schedules
Our team develops randomisation schedules that minimise experimental bias, tailored specifically to your study’s requirements. For in vitro studies, we offer designs like randomised blocks and Latin squares to control for variability. For in vivo studies, we provide a range of methods, including randomised, randomised block, factorial, sequential, crossover, and Latin square designs, optimising trial balance and interpretability. - Adaptive Trial Design
Adaptive trial design is a valuable tool for medtech studies, particularly when trial adjustments are needed as data emerges. Our designs incorporate adaptive elements, such as interim analyses and sample size re-estimation, providing flexibility while preserving the scientific and regulatory integrity of the trial. - Robustness Analysis
Our sensitivity and robustness analyses assess the influence of key assumptions, study design choices, and statistical methods on trial outcomes. These analyses help account for factors such as non-compliance, protocol deviations, clustering or correlation in data, and baseline imbalances, ensuring that results remain reliable across various scenarios. - Meta-Analysis for Evidence Integration
For trials building upon existing research, meta-analyses consolidate evidence across related studies, using models such as random effects to support findings on device efficacy or safety. Our meta-analyses integrate data from multiple sources to provide comprehensive insights, adding a level of validation and depth to your device’s performance data.
Solutions Tailored to Your Device Type
We recognise that each medtech device type has unique regulatory and analytical requirements. Our services adapt to meet the demands of specific categories. Explore how we tailor our expertise across diagnostics, therapeutic devices, SaMD, and aesthetic medicine, with dedicated data security and pre-clinical options.
- Diagnostics: Precision statistics and sensitivity analysis for diagnostics validation.
- Therapeutic Devices: Trial design and analysis centered on efficacy and safety.
- SaMD & AIaMD: Statistical rigor and reliability for software-based device validation.
- Aesthetic Medicine: Biostatistics aligned with the regulatory pathways specific to aesthetic treatments.
- Data Security: Comprehensive data protection measures for sensitive device data.
- Pre-Clinical & Exploratory Studies: Foundational statistical support for early-phase studies.
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Why Choose our Biostatistical Expertise for your Clinical Trial?
Outsourcing your clinical study design, data management and statistical analysis needs to Anatomise Biostats will ensure that your research data is collected and analysed correctly, first time, saving you resources over the course of your projects. This delegation will allow you to focus more intently on your research and product development goals. We can advise on the best statistical analysis and data collection approaches for your situation and aide in the correct interpretation of any results derived from your study data. This means your product or treatment is more likely to stand up under regulatory scrutiny and that the money you invest in research is giving you the return on investment you would hope for in the form of accurate, actionable insights. A unique characteristic of our services is that we are able to combine both biostatistical and bioinformatics approaches. This allows you to supplement your research queries with a genomics or big data element where beneficial. We remain open to innovation in determining the ways in which we can best serve your research goals.
Data Security & Confidentiality
All data sets sent to us for statistical analysis can be sent through encryption and kept in encrypted storage for the duration of the project and an agreed-upon time thereafter. We do not share your data or the details of your projects to any third parties. If privacy is particularly important to you, we will arrange for non-disclosure agreements to be signed to this effect. Our consultants are bound by an internal code of conduct which prohibits them from sharing client study details without permission.
Ready to navigate the complexities of medtech trials? Contact Anatomise Biostats to discuss how our tailored biostatistical services can support your clinical trial from start to finish.
Joint Ventures & Corporate Partnerships
We work for our clients (primarily in small and medium-sized R&D companies) by fulfilling advanced biostatistics and bioinformatics consulting needs. Predominately, this comes in the form of statistical support for pre-clinical studies and clinical trials. We can also set up collaborations with our partner companies to provide a more comprehensive service package for your project, if needed.