Scientific and Rigorous Biostatistics Solutions
LinShutong has a team of senior biostatisticians providing comprehensive statistical support from study design to final analysis. Our statistical experts are proficient in various clinical trial designs, including superiority, non-inferiority, and equivalence trials, and can develop scientifically sound statistical analysis strategies for you.
We strictly follow ICH E9 statistical guidelines to ensure the scientific validity and standardization of all statistical analysis methods, providing reliable statistical evidence for your clinical trial results.
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Following ICH E9 guidelines, compliant with FDA, NMPA and other regulatory requirements
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Rich experience in oncology, cardiovascular, endocrinology and other therapeutic areas
Biostatistics Services
Biostatistics
Professional Biostatistics Services
Sample Size Calculation
Based on research hypotheses, primary endpoints, and expected effect sizes, we perform precise sample size estimation to ensure the study has sufficient statistical power
SAP Development
Develop detailed Statistical Analysis Plans (SAP), including analysis populations, statistical methods, missing data handling, multiplicity adjustments, etc.
Randomization Design
Design scientifically sound randomization schemes, including stratification factors, block sizes, allocation ratios, and provide randomization system support
Interim Analysis
Design and execute interim analyses, including efficacy boundaries, futility analyses, sample size re-estimation and other adaptive designs
Statistical Analysis Reports
Write statistical sections for CSRs, provide complete result interpretation and clinical significance analysis to support regulatory submissions
Statistical Consulting
Provide full-process statistical consulting services, participate in protocol design, regulatory communication, Data Monitoring Committee (DMC) support, etc.
Why Choose Our Biostatistics Services
Senior biostatistician team with rich regulatory communication experience, providing scientifically reliable statistical support for your clinical trials
Learn MoreProfessional Qualifications
PhD/Master's degrees in Statistics, certified biostatisticians, continuous industry training
Therapeutic Expertise
Deep expertise in oncology, cardiovascular, metabolic, neurology and other therapeutic areas, familiar with various study designs
Regulatory Experience
Rich experience in FDA, NMPA communications, supporting statistical work for IND, NDA/BLA submissions
Quick Response
7x24 technical support, rapid response to client needs, ensuring projects proceed on schedule
Full Biostatistics Support Process
Study Design & Consulting
Participate in protocol design, determine primary/secondary endpoints, perform sample size calculation, develop randomization strategy
SAP & Mock Shell
Write statistical analysis plans, create Mock Shell tables, clarify all analysis methods and output formats
Interim Analysis & DMC
Execute planned interim analyses, support Data Monitoring Committee (DMC) work, conduct safety monitoring
Final Analysis & Reporting
Execute final statistical analysis, write CSR statistical sections, provide result interpretation and regulatory support
Biostatistics Services FAQ
We support various types of clinical trial designs, including randomized controlled trials (RCT), single-arm trials, crossover designs, factorial designs, adaptive designs, basket/umbrella trials, etc. Whether it's superiority, non-inferiority, or equivalence trials, we can provide professional statistical support.
Sample size calculation typically requires the following information: primary endpoint type and metrics, expected effect size, significance level (α), statistical power (1-β), dropout rate, and possible stratification factors. We will discuss research hypotheses with you in detail to ensure accurate and reliable sample size calculation.
Yes, we provide comprehensive adaptive design support, including group sequential designs, sample size re-estimation, adaptive randomization, seamless Phase II/III designs, etc. Our statisticians are familiar with adaptive design statistical methods and regulatory requirements, and can help you design and execute complex adaptive trials.
We strictly follow the requirements for statistical analysis independence in ICH E9 guidelines. For blinded trials, we establish independent statistical teams, use independent databases, and ensure analysts remain blinded before analysis. For interim analyses, we support independent DMCs for data review.