Biostatistical Services

Biostatistical ServicesWe are the  industry leader in complex study design consultancy. Our renowned expertise covers adaptive trial design implementation, covariate adaptive dynamic randomisation methodologies and cohort designs.

Our world-class Biostatisticians set us apart 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® Biostatistical Consulting

Selection of methodology and associated parameterization:

  • Choice of stratification factors and / or block size
  • Optimal set-up for covariate adaptive 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.

Randomization List Generation Services

Subject randomization 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 or psychometric support and services