Excellence in Clinical Trial Biostatistics

With 22 years of industry experience, GCP ClinPlus delivers unparalleled biostatistical expertise across the full spectrum of clinical development. Our biostatistics services form the foundation of successful clinical trials, ensuring methodological rigor, regulatory compliance, and robust evidence generation for your drug and medical device development programs.

Our global team of senior biostatisticians brings extensive knowledge from leading pharmaceutical companies such as Novartis, Celgene, and AstraZeneca, providing you with strategic guidance and execution excellence at every stage of your clinical development journey.

Why Choose GCP ClinPlus for Biostatistics?

Regulatory Excellence

● 160+ NDA approvals from FDA, EMA, and NMPA

● 30+ years of global regulatory expertise within our US leadership team

● Specialized knowledge in complex therapeutic areas including oncology, gene therapy, rare disease, and metabolism

Flexible Engagement Models

● Strategic consulting for critical study design decisions

● Full-service outsourcing for end-to-end statistical support

● Functional Service Provider (FSP) models for seamless team extension

● Hybrid approaches tailored to your specific organizational needs

Proven Results

● $30 million in savings achieved for one client through our hybrid biometrics model

● Zero statistical errors across multiple FDA submissions

● Efficient resource scaling during peak periods without permanent headcount costs

Our Comprehensive Biostatistics Services

Strategic Statistical Consulting

Our seasoned biostatisticians provide expert guidance on:

● Protocol development and design to optimize your study approach and maximize chances of success

● Sample size calculations that balance statistical power with operational feasibility

● Innovative statistical methodologies including adaptive designs, Bayesian approaches, and complex endpoints

● Regulatory strategy leveraging our extensive experience with health authorities worldwide

Statistical Analysis Planning

We ensure statistically sound and regulatory-compliant analysis through:

● Statistical Analysis Plan (SAP) development that aligns with protocol objectives and regulatory expectations

● Analysis dataset specifications that conform to current standards (CDISC ADaM)

● Table, listing, and figure (TLF) specifications designed for clear data presentation and interpretation

● Statistical programming to efficiently implement complex analyses

Statistical Analysis and Reporting

Our comprehensive analysis and reporting services include:

● Efficacy and safety analyses across all phases of clinical development

● Integrated analyses for regulatory submissions (ISS/ISE)

● Post-hoc and exploratory analyses to extract maximum value from your data

● Specialized analyses including PK/PD, QTc, biomarker, and health economics

Regulatory Support

We provide comprehensive statistical support for regulatory interactions:

● Statistical sections for regulatory documents including clinical study reports, briefing books, and submission dossiers

● Preparation for regulatory meetings including assistance with statistical questions

● Response to regulatory queries leveraging our deep understanding of agency expectations

● Advisory committee preparation including statistical presentation development

Therapeutic Area Expertise

Our biostatisticians have extensive experience across multiple therapeutic areas, including:

● Oncology: Solid tumors, hematological malignancies, immuno-oncology

● Rare Diseases: Innovative designs for limited patient populations

● Gene Therapy: Novel endpoints and specialized analysis approaches

● Neurology: Alzheimer's, Parkinson's, multiple sclerosis, and other neurological conditions

● Ophthalmology: Visual acuity, intraocular pressure, and other specialized endpoints

● Cardiovascular: Heart failure, atherosclerosis, arrhythmia, and hypertension

● Metabolic Disorders: Diabetes, obesity, and metabolic syndrome

● Hematology: Hemophilia, sickle cell disease, and other blood disorders

FSP Expertise: Flexible Scaling Without Compromise

Our Functional Service Provider (FSP) model offers:

● Rapid access to experienced biostatistics professionals

● Seamless integration with your existing team through our proven onboarding processes

● Flexible scaling to accommodate pipeline fluctuations

● Cost efficiency compared to maintaining permanent staff for variable workloads

● Knowledge continuity through dedicated resources aligned with your programs

Our Approach to Excellence

GCP ClinPlus biostatisticians apply a systematic approach to ensure quality and efficiency:

● Early engagement to optimize study design and statistical methodology

● Comprehensive quality control processes that catch issues before they impact timelines

● Cross-functional collaboration with data management, programming, and medical writing teams

● Proactive risk identification and mitigation strategies

● Continuous innovation in statistical methodologies and processes

Case Studies

Successful Hybrid Biometrics Model

A mid-sized biotech specializing in RNA-targeted therapeutics adopted a hybrid approach—maintaining core biostatistics leadership in-house while partnering with GCP ClinPlus for execution. This model supported three successful FDA NDA approvals with zero statistical errors, while achieving approximately $30 million in cost savings compared to building equivalent capabilities internally.

Flexible FSP Scaling for Changing Demands

A US subsidiary of a global ophthalmic pharmaceutical company utilized GCP ClinPlus' SAS programmer FSP services to manage workload fluctuations during peak trial periods. This approach allowed them to efficiently scale their biometrics team without permanent headcount costs—expanding capacity during critical submission preparation phases and reducing it during quieter periods.

Meet Our Biostatistics Leadership

Our biostatistics team is led by industry veterans with extensive experience across pharmaceutical, biotech, and CRO environments. Their combined expertise ensures that your clinical development programs benefit from the latest statistical methodologies while maintaining regulatory compliance and operational efficiency.

Start Your Journey to Statistical Excellence

Contact us today for a complimentary assessment of your protocol, analysis plan, biometrics resources, and vendor gaps. Our experts will help you identify the optimal statistical approach for your clinical development programs.

Contact: Suling Zhang, VP of International Operations and Business Development
 Email: suling.zhang@gcp-clinplus.com
 Phone: 609-255-3581