Programming and Statistics

Our statistics and programming team have a wealth of experience in analysis of data from clinical trials across all phases of clinical development, ranging from first-in-man to international, late phase trials.  In particular, they have extensive experience in analysis of early-phase PK data (including bioequivalence, accumulation, time to steady state, dose-proportionality, drug-drug interaction, and ethnic bridging analyses) and PD data (such as validated questionnaires, Bond-Lader, visual analogue scales, laboratory variables, and respiratory and cognitive function data), as a result of their delivery of many full-service clinical trial packages at HMR.  All our deliverables are compliant with CDISC and international guidelines.

Your dedicated statistician will oversee your analysis from trial design through to reporting, ensuring that your requirements are captured in our detailed statistical and analysis plan and executed accurately and efficiently.

 

Our clinical programming and statistics services include:

  • Statistical expertise:
    • Trial design, data analysis and protocol review
    • Sample size calculations
    • Input/review of clinical trial report
    • Consultancy services, eg analysis of data from stability studies, validation of laboratory assays, laboratory normal ranges
  • Randomisation:
    • Advice on methods
    • Provision and distribution of randomisation lists and code break envelopes.
  • Statistical analysis plan: Inclusive of mock output shells
  • Analyses
    • Rapid, high quality interim analyses to support data-driven decisions in ongoing trials
    • Calculation of PK parameters using Phoenix (WinNonlin)
    • High quality tables, figures and listings (TFLs) for clinical trial reports, generated using SAS® and verified using comprehensive quality control procedures, including independent programming
  • Data mapping and submission to regulatory agencies
  • CDISC compliant deliverables:
    • STDM
    • ADaM
    • Reviewer guides
    • define.xml.
    • Legacy data conversion to SDTM