Our diverse team of statisticians has experience that spans many therapeutic areas and phases of clinical trials from Phase I to Phase IV, as well as pre-clinical, observational and registry studies.
Range of skills
We pride ourselves on combining innovation with technical expertise and have a reputation for customer focus, such that our statisticians are often seen as a seamless extension of our clients’ teams.
We have rigorous project management and governance procedures in place and communicate openly and honestly with clients so you’re always aware of progress and up to date with the latest project developments.
- Clinical study design – Supporting the clinical team to develop the right study design, whether that is a standard or novel design. Our statisticians have experience in both adaptive and Bayesian methods so as to optimise the probability of study success.
- Simulations – Providing study simulations to improve the understanding of how unknown factors may impact on the clinical trial results – endpoint variability, recruitment and drop out, treatment effects, and so on.
- Protocol – Statistical support in the development of the clinical trial protocol (and amendments) with consideration to the recent ICH E9 addendum around estimands.
- Randomisation – Producing randomisation lists and advising on the most appropriate randomisation method for a particular study.
- Vendor oversight – Providing third party vendor oversight by managing timelines and reviewing statistical deliverables to ensure the highest quality for your trial.
- Interim Analyses – Offering expert advice on the design, management and implementation of an interim look at the data, whether blinded or unblinded.
- DMCs / DSMBs – Preparing and providing the analyses and report for the committee members. Our most experienced team members can act as the independent statistician assisting the committee to make the appropriate decision for the study.
Analysis and reporting
- Statistical Analysis Plans – Developing and/or reviewing clear and detailed SAPs and supporting mock output shells, in accordance with ICH E9, for clinical study reports, interims and DMCs.
- Statistical Analysis Expertise – Our statisticians have experience across most common and advanced statistical methodologies. Of particular note:
- MMRM – Extensive design experience of fixed and mixed effects models across phases and indications. Experience in handling non-convergence of models and assessing the best choice of model options.
- Multiple Imputation (incl. Pattern Mixture Models) – Experience of various types of missing data models, including hot deck imputation and tipping point methods.
- Multiple Testing Strategies – Knowledge in applying hierarchical testing due to multiplicity. In-house statistical expertise in assessing strategies to control type I errors in adaptive designs and standard trials, along with experience of closed testing procedures to illustrate type I error control.
- Multiple Failure Time Models – Application of Poisson, zero-inflated Poisson and negative binomial event models.
- PK/PD analysis – Modelling the relationship between exposure and response using non-linear models and non-linear mixed effect modelling.
- Clinical study reports (CSR) – Supporting the development of the clinical study report to ensure the statistical accuracy of the conclusions drawn from your study.
Post reporting / Submission activities
- Integrated summaries of safety & efficacy (ISS/ISE) – Guiding and assisting in the integration of safety and efficacy data across multiple studies prior to regulatory approval.
- Publications – Providing support throughout the publication process, from the concept, identification and implementation of appropriate analyses, right through to the interpretation of the results.