Clinical Biostatistical Services

We are the industry leader in complex clinical study design consultancy. Our renowned expertise covers adaptive trial design implementation, covariate adaptive dynamic randomisation methodologies and cohort designs. Biostatistic Services in clinical trials will provide the information you need to make the decisions that will benefit your patients. 

Our world-class Biostatisticians set us apart from the competition - their expertise, experience and reputation is of the highest caliber in the clinical R&D community.

From simple to complex studies, our knowledgeable and customer-focused Biostatistical Consultants will ensure that the needs of your study are fully understood and accurately implemented.

IXRS® Interactive Response Technology - Biostatistical Consulting

Selection of methodology and associated parameterisation:

  • Choice of stratification factors and/or block size
  • Optimal set-up for covariate adaptive clinical trial randomisation
  • Regulatory considerations
  • Simulation programs available to enable quick determination of optimal methodology
  • Impact on supply requirements and overage
  • IXRS® implementation of adaptive trial designs
  • Considerations related to forced randomisation, subject replacement, randomised sub-study assignment and re-randomisation.

We are pioneers in adaptive and other dynamic clinical trial randomisation techniques. To assist you in the design and implementation of dynamic randomisation and dose titration schemes, our in-house Biostatisticians offer upfront clinical biostatistics 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® Interactive Response Technology:

  • 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® Interactive Response Technology and eCOA (Electronic Clinical Outcome Assessment) 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

Clinical randomisation list generation services

Subject randomisation lists:

  • Fixed or variable block sizes, stratification, cohorts, sub-study assignment, subject replacement lists and re-randomisation.
  • Clinical supply kit lists:
    • Double-blind and open-label kit lists
  •  Random number lists:
    • For biased-coin assignment and authorisation codes
      I. Rand List generation services
      II. ePRO (Electronic Patient-Reported Outcome) or psychometric support and services

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