Biostatistics
From study design and adaptive methods to PK/PD analytics, DSMB support, and CSR outputs, our biostatisticians deliver rigorous, submission-ready analyses across the clinical development lifecycle
Biostatistics Built for Scientific Rigor and Regulatory Confidence
Biostatistics at IQA is not a downstream support function. It is a scientific partnership embedded from study design through final analysis and regulatory delivery. Our statisticians support clinical, medical device, and evidence-generation programs with the rigor needed for confident development decisions and submission-ready outputs.
We work across nonclinical and clinical development, Phase I–IV studies, BA/BE, medical devices, RWE/observational research, HEOR, epidemiology, IITs, and retrospective studies. From estimand strategy and adaptive design simulation to SAP development, DSMB/DMC support, and integrated CSR outputs, we deliver analysis that is scientifically robust, operationally aligned, and regulator ready.
Study Domain Coverage
Biostatistics Support Across Design, Analysis, and Submission
From nonclinical studies and protocol design to analysis, governance, and regulatory submission support, our biostatistics team delivers connected statistical expertise across the product lifecycle.
Statistical Tools and Standards Built for Submission-Ready Delivery
Our statisticians work in SAS, R, Python and Julia - with full audit trails, CDISC-compliant analysis datasets and reviewer-friendly TLF outputs that regulators can trace back to source data.
Biostatisticians Who Understand Your Program, Not Just Your Data
Scientific partnership, advanced methods, and submission-ready execution across clinical, device, and evidence-generation programs.
Full Spectrum Coverage
Across clinical trials, medical devices, BA/BE, RWE, HEOR, epidemiology, IITs, and retrospective studies, one biostatistics team supports the full development continuum.
Advanced Methods by Default
Bayesian, adaptive, PK/PD, causal inference, and fit-for-purpose synthetic or external control approaches are applied when they add real decision value.
Estimand-Driven from Protocol
We embed estimand thinking early in study design, aligned with ICH E9(R1), so analysis strategy is built in, not retrofitted later.
Audit-Ready, Reviewer-Friendly
Our outputs are designed for traceability, clarity, and regulatory review, with robust QC, CDISC-aligned thinking, and documentation that reviewers can navigate with confidence.
Integrated with Clinical & Data Teams
Biostatistics works in close coordination with programming, clinical operations, data management, medical writing, and pharmacovigilance to support connected delivery.
Regulatory-Ready Statistical Support
From protocol input and SAPs to CSR outputs, ISS/ISE, health authority responses, and advisory support, we deliver analyses built for submission and scientific defense.
Need Statistical Expertise for Your Trial?
From study design consultation to DSMB support - our biostatisticians are ready to partner with you.