Biostatistics
Our biostatistics team have a strong focus on accuracy and clarity, whilst still offering a tailored, collaborative service that meets deadlines, allowing our clients to keep timelines and costs to a minimum. Our statisticians provide statistical consultancy support and have expertise across the full range of statistical activities needed to progress a product through the drug development process and post marketing (during lifecycle management).
We have extensive experience of working with small early-stage biotech companies as well as large international pharmaceutical organisations within a variety of different disease areas. We have also experience within the medical device area.
Our services
Study Design
Statistical input to protocols, including design, choice of estimands, sample size, randomisation and preparation of the statistical analysis plan (SAP). We have experience within all phases of pharmaceutical clinical development, including late phase observational trials, and trials based on real world data / registry data. Further, we have experience with planning of explorative and pivotal trials within the medical device and diagnostic tests area.
Study Reporting
Statistical analyses in accordance with the SAP, including interim analyses and pharmacokinetic analyses. We also conduct explorative post-hoc analyses. We provide input to and review of the clinical trial report
Submission Support
Planning, preparation and review of the integrated summary of safety (ISS), the integrated summary of efficacy (ISE), and the clinical pharmacology summary. Assistance during the question and answer period.
Post Marketing and Lifecycle Management Activities
For example, meta-analyses, indirect comparisons, sub-group analyses, analyses of real-world data
Regulatory Meetings
Preparation and attendance at agency meetings
Additional Statistical Support
Such as independent quality control of statistical activities, statistical due diligence (e.g. in-licencing of drugs), journal manuscript input and review, and advice on processes.
Get in Touch
Our Team will get back to you
as soon as possible.
Biostatistics News
Mark Baillet – A View from the Biometrics Managing Director’s Office
COVID-19 Vaccines trials …
S-cubed Biometrics’ Mark Baillet: Why Choose Us?
Mark Baillet discusses why S-cubed is a good partner for your trial.
Supporting Clients using Full Service CROs
Our Biometrics team discuss how S-cubed can help companies that outsource Biometrics activities to a full-service CRO.
Finalised ICH E9(R1) Estimands and Sensitivity Analysis Guidance
We revisit Estimands after it’s adoption in November. Find out how we can help.