CNS' Biostatistical team's core activities are to provide biostatistical and pharmacokinetic/pharmacodynamic analysis and data presentation services to the pharmaceutical/biotech industry and government/academic organisations, with a primary focus on data generated from clinical trials.
These services include undertaking:
- Study design and sample size/power calculations
- Statistical analysis plan (SAP) and protocol writing
- Randomisation procedures
- Table, figure and listing presentations for documents to be submitted to regulatory authorities
- Standard hypothesis testing i.e. comparison of groups
- Statistical data modelling (e.g. regression, general linear modelling, non-linear modelling, mixed-effects modelling, survival analysis, etc.)
- Pharmacokinetic/pharmacodynamic analysis including non-compartmental analysis (NCA) and population non-linear mixed effects modelling and simulation
- Optimal design of experiments
- Clinical trial simulation
- Data review and quality assurance
- Data summaries, reports and publications
- Interpretation and communication of results to non-statistical audiences
All analyses are undertaken with programmed reproducible methods using industry standard software packages including SAS, R, WinNonlin and NONMEM. All work is undertaken and stored in a secure, dependable and fully backed-up computing environment and in accordance with our own SOP’s and work instruction documents.
We have a dedicated and enthusiastic team who have joined us from employment in industry and academia, bringing experience in the analysis of clinical, pre-clinical and in-vitro data. The CNS biometrics group has worked with a wide range of organisations and considers effective communication and project management fundamental to our interactions with clients. We also commonly work with external data management groups (in addition to our own internal group) and service providers such as pathology, analytical laboratories, clinical sites and medical staff.