The Centre for Evaluation of Medicines

By: The Centre For Evaluation Of Medicines  09-12-2011

The Biostatistics Unit provides a wide spectrum of services:

  1. Research design to ensure the integrity of the research protocol, including:
    • guidance on preparation of grant proposals
    • identification of the most efficient design and planning of research studies
    • assistance with devising effective sampling strategies
    • help with sample size determination and power calculations, and
    • hypothesis development
  2. Central telephone randomization service:
    • service available 24 hours a day, 7 days a week
    • methods of randomization available:
      unrestricted: simple randomization
      restricted: block randomization
      stratified randomization
    • examination of the distributional properties of the sequence prior to first allocation
    • full documentation provided
  3. Case Report Form (CRF) design and development:
    • provide assistance designing the CRF
    • develop and thoroughly test the CRF prior to use
    • data base designed to accommodate data collected on the CRF
  4. Data management services:
    • data entry
      - completed forms are faxed to a secure computer at the Biostatistics Unit for data entry
      - faxed data forms can be received 24 hours a day, 7 days a week
      - data entry usually takes place the next business day
      - data are entered while the original CRF remains at the clinical site (no
      postage costs, no CRFs get lost in transport, CRFs remain in a secure
      location, photocopying of CRF is not necessary)
    • data Cleaning
      - query resolution takes place while study is ongoing
      - clean database ensured shortly after study completion
    • periodic data management update reports are provided to investigator
  5. Data analysis using standard statistical techniques and powerful state-of-the-art methods, including:
    • advice on what software to use
    • tabular and graphical representation of data
    • analysis using routine and advanced statistical procedures
    • examination of model assumptions through diagnostic tests
  6. Interpretation of results: interpretation of statistical analyses to enhance communication of the results in a clear, meaningful way, including:
    • clear descriptions of methods used to analyze the data
    • detailed reporting of the analysis results
    • assistance with report writing for granting agencies
    • assistance with manuscript preparation
  7. Short courses and workshops: customized short courses and workshops on various statistical topics, including:
    • Bayesian methods
    • meta-analysis methods
    • writing workshops
    • statistical consulting
    • multivariate statistical methods


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