Biostatistics — IDDCR Global Research
Biostatistics
Rigorous statistical science supporting every stage of clinical development.
IDDCR's biostatistics team delivers expert statistical support across all phases of clinical research — from study design and sample size calculations through final statistical analysis and regulatory submission.
Our Approach to Biostatistics
Our biostatisticians bring deep expertise in clinical trial methodology, regulatory statistics and therapeutic area-specific analytical approaches. We work closely with sponsors, medical teams and regulatory agencies to deliver statistically sound, scientifically rigorous analyses that support regulatory decision-making and publication.
Core Capabilities
Study Design & Sample Size
Statistical input into protocol design, sample size and power calculations, randomisation scheme development and adaptive design methodology.
Statistical Analysis Plan
Comprehensive SAP development aligned to ICH E9, E9(R1) and regulatory guidance, covering all primary, secondary and exploratory analyses.
Interim Analysis & DSMB Support
Interim analysis planning and execution, DSMB/DMC statistical support, blinded and unblinded analyses with appropriate firewall procedures.
Final Statistical Analysis
Execution of all planned analyses per the SAP, production of statistical outputs and review of TFLs for accuracy and consistency.
Regulatory Submission Support
Statistical sections of CSRs, responses to regulatory queries, integrated summaries of efficacy and safety, and NDA/BLA/MAA statistical support.
Estimands & Missing Data
Estimand framework implementation per ICH E9(R1), sensitivity analyses, multiple imputation and handling of intercurrent events.
Therapeutic Areas
Development Phases
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Frequently Asked Questions
Common questions about this service — answered by our specialist team.
Looking for Biostatistics Expertise?
Connect with our biostatistics team to discuss your study design, analysis requirements and regulatory strategy.