Biostatistics Services

Experts in study design and analysis

Our team of in-house Biostatisticians have a long track record of reliable support for a diverse range of development projects, regardless of size, therapeutic area, or complexity. They are key members in all our project teams and provide input to study design, the statistical analysis plan, sample size calculations, selection of endpoints, statistical programming and analysis. Working as an extension of your in-house team and included early on in the development of your product, they will put your needs first, and are always on hand to provide guidance, planning and ensure delivery of high-quality data and full optimization of your trial.

  • Study design – we can ensure optimized study design from the start, as well as sample size calculation, statistical methods and study data endpoints.
  • Regulatory Authority Meetings – our senior Biostatisticians can participate in meetings with regulatory bodies to present study design and statistical methodology for your planned clinical trial.
  • Randomization – our Biostatisticians will create the Statistical Analysis Plan (SAP) that details the planned analyses with respect to trial objectives and endpoints.
  • Programming of Analysis Dataset – our Biostatisticians and Programmers will develop datasets to facilitate the statistical analysis described in the SAP. We have broad experience of CDISC standard (SDTM and ADaM).
  • Statistical analyses – based on the SAP and analysis datasets, we will create all statistical analyses and tables, listings and figures for the clinical study report.
  • Interim Analysis – any interim analysis will be performed by our Biostatisticians as outlined in the Study Protocol/SAP.
  • Data Monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB) support – we provide DSMB management and provision of study data for efficient data evaluation
  • Writing of Statistical report/Input to Clinical Study Report – our Biostatisticians work in close collaboration with the Medical Writer to provide input to the Clinical Study Report, or can provide a separate statistical report.
  • Publications – our Medical Writing team, in collaboration with our Biostatisticians, will effectively communicate your study results to a wider scientific audience.

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