Biostatistics and SAS® Programming

Designed for quality

Scope International’s expert biostatisticians handle your study from start to finish – from design and SAS® programming to testing, analysis and reporting. By cooperating closely with our project managers, data managers, medical monitors and writers, our biostatistics team develops flexible solutions to fit your needs – always working together with your goal in mind. Working with industry-standard SAS®, our team delivers high-quality analysis whenever required.

Why not contact us to see how we can support your study?

  • Statistical advice on study design and protocol preparation
  • Sample size calculations
  • Input in CRF/eCRF design
  • Statistical analysis planning (SAP)
  • Interim analyses
  • Statistical analysis of clinical data and validation using SAS®
  • Support to ISS/ISE (Integrated Summary of Safety and Efficacy) and DSMB (Data and Safety Monitoring Boards)
  • Preparation (programming) statistical Tables Listings and Figures
  • Input Clinical trial report
  • Result evaluation
  • Randomisation, including provision of randomisation schedule with treatment information and random code envelopes
  • Meta analysis
  • CDISC standards implementation
    • SDTM and ADaM dataset production
    • Data mapping across different standards
    • Programming specifications for SDTM and ADaM datasets
    • Creation of define.xml and SAS xpt data sets; annotated CRF for SDTM data sets
  • Risk based validation, double-independent programming
  • Data pooling and development of Integrated ISS/ISE datasets
  • Tables, listings and figures (TLFs) programming
  • Subject profiles and medical review listing programming
  • (Blinded) Data review tables and listings preparation
  • Preparation of validated data/XML files for trial results reporting to EudraCT database
  • Systematic statistical programming to detect potential signals/patterns across different studies
  • Signal detection on product basis/analysis data from different trials

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