Biostatistics

Our biostatistics team have a strong focus on accuracy and clarity, whilst still offering a tailored, collaborative service with a quick turnaround, 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.

 

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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.

DSMB

We support all aspects of DSMBs, whether it be participation as an independent statistician and/or preparation of charters and analyses.

Regulatory Agency Meetings

We can accompany you as the responsible statistician, as well as perform analyses, review/prepare answers to agency questions and supporting material and perform presentations, at regulatory authority agency meetings.

Statistical Consulting

We can provide statistical oversight for those clients that need an experienced statistician to support their drug programmes and/or perform Sponsor oversight of outsourced statistical services.

Post Marketing and Lifecycle Management Activities

For example, meta-analyses, indirect comparisons, sub-group analyses, analyses of real-world data.

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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.

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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