Biostatistical Consulting

Conducting many of the industry’s most complex studies

We are pioneers in adaptive and other dynamic randomisation techniques. To assist you in the design and implementation of dynamic randomisation and dose titration schemes, our in-house statisticians offer upfront consultancy during the planning phase. Their expertise will also be applied throughout your study’s life cycle to ensure its successful execution.

Numerous randomisation methodologies via IXRS®:

  • Permuted block list approaches (central, simple through to complex stratification)
  • Covariate adaptive (dynamic) randomisation methodologies, including:
    • Pocock and Simon minimisation with biased-coin assignment
    • Dynamic hierarchical methodologies
    • Custom methodologies
    • Adaptive trial designs

Adaptive trial designs

Well-designed adaptive trials result in lower drug development costs, reduced timings, faster decisions and improved patient safety. IXRS® and eCOA tools capture safety and efficacy data and make it viewable in real-time – providing sponsors with the information they need, when they need it quickly.

We have implemented more than 100 adaptive studies and established a reputation as a market leader in adaptive trial designs including:

  • Fixed interim designs
  • Bayesian response adaptive algorithms

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