---
name: Quanticate
slug: quanticate
site: cro
website_domain: quanticate.com
summary: Quanticate is a biometrics CRO with 30 years of expertise in biostatistics, clinical data management, and pharmacovigilance across all clinical trial phases. The company specializes in statistical protocol design, CDISC standards compliance, and real-world data analysis to support regulatory submissions. Headquartered in Hitchin, United Kingdom.
tagline: 30 years of biostatistics expertise supporting clinical trials from protocol design through regulatory submission.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: GB
tier2_domain_verified: false
updated_at: 2026-06-17T07:00:57.741Z
services_count: 6
modalities_count: 0
indications_count: 0
locations_count: 8
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Quanticate

30 years of biostatistics expertise supporting clinical trials from protocol design through regulatory submission.

Listed on cro.directory.

## Summary

Quanticate is a biometrics CRO with 30 years of expertise in biostatistics, clinical data management, and pharmacovigilance across all clinical trial phases. The company specializes in statistical protocol design, CDISC standards compliance, and real-world data analysis to support regulatory submissions. Headquartered in Hitchin, United Kingdom.

## At a glance

- HQ country: GB

## Services

- Biostatistics & Statistical Programming
- Data Management & eClinical
- Clinical Operations
- Medical Writing
- Pharmacovigilance & Drug Safety
- Regulatory Affairs

## Locations

- Headquarters, Hitchin, Hertfordshire, United Kingdom
- Raleigh, Raleigh, North Carolina, United States
- Warsaw, Warsaw, Poland
- Bloemfontein, Bloemfontein, South Africa
- Bangalore, Bangalore, India
- Hyderabad, Hyderabad, Telangana, India
- Manchester, Wilmslow, Cheshire, United Kingdom
- Toronto, Mississauga, Ontario, Canada

## Long description

## 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.

_Profile last updated: 2026-06-17T07:00:57.741Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.