Statistical Services for Clinical Trials
With extensive experience in CRO and academic research environments, I provide independent biostatistical support across the full clinical trial lifecycle. Working directly with sponsors, I deliver rigorous, audit-ready statistical outputs that meet ICH, FDA, and EMA expectations – from first-in-human studies through to submission-ready packages.
End-to-End Trial Support
Clinical trials demand statistical input at every stage. I offer flexible engagement – whether you need support across the full trial lifecycle or targeted expertise at a specific phase. All deliverables are produced to the standards expected in a regulated CRO environment, with clear documentation and sponsor communication throughout.
Study Design & Protocol Review
Sound statistical design is the foundation of any successful trial. I work with sponsors and clinical teams during protocol development to ensure the study design is fit for purpose, endpoints are appropriately defined, and statistical assumptions are well-justified. Protocol review services include critical appraisal of the statistical sections, identification of ambiguities, and recommendations prior to submission or ethics review.
Sample Size & Power Calculations
Accurate sample size determination is critical to trial feasibility and regulatory credibility. I provide clearly documented power calculations with full justification of assumptions – covering superiority, non-inferiority, equivalence, and exploratory designs across a range of therapeutic areas and endpoint types. Calculations are delivered in a format suitable for inclusion in protocols and briefing documents.
Randomisation Schedule Preparation
I prepare randomisation schedules to support blinded and open-label trials, including stratified and block randomisation designs. Schedules are produced with appropriate documentation for inclusion in the Trial Master File and are compatible with IRT/IVRS system requirements where applicable.
Blinding & Randomisation Management
I provide end-to-end management of study blinding for clinical trials, including the production of randomisation schedules, preparation and printing of code break slips, secure distribution to appropriate parties, and formal unblinding procedures following database lock. These services are delivered in accordance with ICH E9 and applicable GCP requirements, with full documentation to support regulatory submission.
Statistical Analysis Plan (SAP) Development
A well-constructed SAP is essential for regulatory confidence and trial integrity. I prepare comprehensive SAPs aligned with ICH E9 and E9(R1) guidelines, covering the full specification of analysis populations, estimands, handling of missing data, and sensitivity analyses. SAPs are written to be unambiguous and executable, minimising the risk of post-hoc interpretation at the analysis stage.
Mock Shell & Data Display Plan Preparation
Clear agreement on output structure before programming begins saves time and reduces rework. I develop TFL mock shells and data display plans in collaboration with sponsors and programming teams, ensuring that planned outputs map directly to SAP specifications and meet the expectations of clinical study reports and regulatory submissions.
eCRF Review
Statistical review of the electronic Case Report Form prior to database build helps prevent data collection issues that are costly to resolve later. I review eCRF designs with a focus on data completeness, consistency with the protocol and SAP, and suitability for downstream statistical analysis and CDISC mapping.
TFL Production & Review
I provide statistical oversight of Tables, Figures, and Listings – reviewing outputs for accuracy, consistency with the SAP, and suitability for inclusion in clinical study reports. For sponsors requiring independent statistical review, I offer a structured TFL quality review service with documented sign-off.
Statistical Modelling & Analysis
From standard efficacy and safety analyses through to more complex modelling requirements, I deliver statistical analyses with full documentation of methods, software, and results. Analytical outputs are produced in R or SAS and are traceable, reproducible, and ready for regulatory scrutiny.
CDISC Standards & Reviewer’s Guide
I provide support for CDISC-compliant submissions, including review of SDTM and ADaM datasets and preparation of the Define-XML and CDISC Reviewer’s Guide. This service ensures your submission package meets current FDA and PMDA electronic data requirements and is ready for regulatory reviewer inspection.
DBL to Delivery Project Management
The period from Database Lock and study unblinding to final CDISC and TFL delivery is one of the highest-pressure phases of any trial. I provide statistical project management across this phase – coordinating timelines, managing dependencies between programming and statistics teams, and ensuring deliverables are completed accurately and on schedule.
Academic Research Support
I work with honours and postgraduate students and academic researchers across all stages of the research process. Services include study design and endpoint definition, sample size and power calculations suitable for ethics submissions and grant applications, data cleaning and preparation, and statistical modelling across a broad range of methods including regression, mixed models, and survival analysis. I can also assist with the preparation of tables, figures, and written statistical summaries for theses, manuscripts, and conference presentations. All work is conducted in a manner consistent with university academic integrity requirements and is designed to support your own intellectual contribution.
Ready to discuss your trial?
Whether you are planning a new study or need statistical support mid-trial, I welcome the opportunity to understand your requirements. Please get in touch to arrange an initial consultation.
