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.

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.

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