Biostatistical Services
We 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
- For biased-coin assignment and authorisation codes
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