Contract Research Organization

Statistical excellence
for clinical trials

From Phase I through Phase III, BioStatClin delivers rigorous biostatistics and data science solutions that accelerate your path to regulatory approval.

Phase I–II
Study Design & Protocol
Sample size, endpoints, adaptive design
Phase II–III
Statistical Analysis Plans
SAP, SDTM/ADaM datasets, DMC services
Regulatory Submission
ISS / ISE / CSR Reporting
Tables, listings, figures & integrated analyses
I–IIITrial Phases
FDACompliant
Oncology+ Infectious Disease

Dedicated statistical support across every trial phase

BioStatClin is a specialized Contract Research Organization focused exclusively on comprehensive statistical support for clinical trials. We partner with pharmaceutical and biotech companies to drive every stage — from study design through regulatory submission.

Our team of experienced statisticians brings deep expertise in regulatory guidelines and cutting-edge statistical methodologies, ensuring your trials are designed for success.

⚕ Infectious Disease & Oncology
Study design & protocol development
Strategic statistical consulting
Endpoint & sample size analysis
Randomization schemes
Statistical analysis plans (SAP)
Adaptive design & simulation
Tables, listings & figures (TLF)
eCRF design & review
ISS / ISE / ISM analyses
Data Monitoring Committee (DMC)
SDTM & ADaM dataset preparation
Submission-ready dataset packages

The right statistical partner
for complex clinical science

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Deep Experience

Years of hands-on expertise in pharmaceutical and biotech trials means we understand the unique challenges your team faces every day.

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Methodology Expertise

Our statisticians stay current with the latest statistical advances and evolving regulatory guidelines, from FDA to ICH E9(R1).

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Tailored Solutions

We don't do one-size-fits-all. Every engagement is structured around the specific goals, design, and constraints of your trial.

Regulatory Compliance

We maintain the highest quality standards and stay aligned with regulatory requirements to help you navigate submission confidently.

On-Time Delivery

Clinical timelines don't wait. We are committed to meeting every milestone without sacrificing the rigor your trial demands.

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True Partnership

We operate as an extension of your team — transparent, communicative, and invested in the scientific and clinical success of your work.

Ready to elevate your clinical trial statistics?

Partner with BioStatClin and bring rigorous statistical analysis to your next trial. Reach out to discuss how we can collaborate and make a meaningful impact on the future of healthcare.

info@biostatclin.com