Quanticate

Overview

Quanticate is a niche biometrics contract research organization (CRO) founded on expertise in statistical analysis, data capture, and clinical trial reporting. With 30 years of industry experience, the company serves pharmaceutical and biotech sponsors across all phases of clinical development.

Core Services

Biostatistics & Study Design

• Protocol review and statistical analysis section writing
• Sample size calculations and power analysis using Frequentist and Bayesian frameworks
• Randomization and unblinding procedures
• Statistical Analysis Plan (SAP) development and output shells
• Interim analysis and Data Safety Monitoring Board (DSMB) support

Clinical Data Management

• Case Report Form (CRF) statistical review
• CDISC standards compliance and SDTM dataset automation via QSummarise (proprietary AI tool)
• Data extraction, mapping, and define.xml readiness
• SAS and R programming for output production

Study Reporting

• Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
• Meta-analysis design and bias assessment
• PK/PD analysis using Phoenix WinNonlin and non-linear mixed-effect modeling
• Clinical Study Report (CSR) statistical review and production

Pharmacovigilance

• Clinical trial pharmacovigilance and patient safety services
• Post-authorization and marketed product safety monitoring
• Medical device vigilance

Real World Data & Evidence

• Health economics and outcomes research (HEOR) using secondary data sources (EMR, claims, healthcare databases)
• Observational studies and post-approval safety research

Technology & Differentiation

Quanticate integrates AI and automation throughout its processes. QSummarise automates 80–95% of complex SDTM mappings while maintaining expert oversight, accelerating data submission timelines. The company leverages validated SAS macros and standardized output shells to enhance efficiency.

Therapeutic Scope

Experience spans all therapeutic areas and all phases of research and development, with scientific principles applied to ensure high-quality data and regulatory-compliant reporting.