What Quanticate does

Quanticate is a privately held, data-focused Contract Research Organisation (CRO) founded in 1994 and headquartered between Hitchin, UK and Raleigh, NC, USA, with 251-500 employees across offices in the UK, US, Canada, Poland, South Africa, and India. The firm operates exclusively in biometrics and clinical data services, offering six core service lines: Statistical Consultancy, Biostatistics, Statistical Programming, Clinical Data Management, Regulatory Medical Writing, and Pharmacovigilance. These are supported by specialist add-on modules including PK/PD analysis, Real World Evidence, ISS/ISE Submissions, Rescue Studies, CDISC Services & Mapping, Functional Service Provision (FSP), Centralised Data Solutions (CDS), Data Quality Oversight, Bayesian Methods in Clinical Design, and Clinical Trial Transparency.

The technology stack is built around the proprietary iQ Portal for centralized clinical and safety data storage, study-level metrics, and cross-study visualization, combined with SAS and R programming environments and CDISC SDTM/ADaM standards compliance. AI and automation tooling is layered on top of these capabilities to accelerate SAP creation, TLF production, and CSR generation, with the stated design intent of combining structured metadata and regulatory standards with human expert review. The firm also applies machine learning techniques to EDC data extracts for clinical data management and programming workflows.

Quanticate generates revenue through professional services contracts under three engagement models: Functional Service Provision (FSP) with multi-year embedded teams billed on an FTE basis, Fixed Cost Projects billed per-engagement, and Full Service CRO Support on multi-year hybrid contracts. The go-to-market is enterprise field sales targeting emerging biotechs, mid-to-large pharmaceutical and biotech companies, and medical device firms, supported by an RFI-driven sales process with two-business-day response SLAs and a content marketing program spanning whitepapers, case studies, videos, podcasts, and major social channels. Selected named customers include a Top 5 Pharmaceutical Company, a Large Global Pharma, a Large Scandinavian Pharmaceutical Company, a European Mid-Size Biotech, and a Fertility Biotech. The company is registered as Quanticate International Limited in England and Wales, with David Underwood serving as Founding CEO and Chairman.

Name

Quanticate

Legal name

Quanticate International Limited

Website

https://quanticate.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

251–500 employees

Short description

Quanticate is a privately held, global biometrics-focused Contract Research Organisation founded in 1994, serving pharmaceutical, biotechnology, and medical device companies with statistical programming, clinical data management, biostatistics, medical writing, and pharmacovigilance services across all clinical trial phases.

Ownership category

akta.pro rank

Product category

Clinical Research Services (Contract Research Organization)

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)

akta.pro secondary industries

Data Management, Biostatistics & Statistical Programming FSP (HLAGAOAB), Medical Writing & Clinical Documentation FSP (HLAGAOAC), Real-World Evidence (RWE), HEOR & Epidemiology CROs (HLAGAAAK)

Keywords

• Clinical research services
• Biometrics CRO services
• Clinical data management
• Statistical programming services
• Pharmacovigilance services

Headquarters

HQ city

Raleigh

HQ country

United States

HQ region

North America

Offices8 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Contract Research Services: Quanticate generates revenue through contract research services including biostatistics, statistical programming, clinical data management, medical writing, pharmacovigilance, and regulatory consulting. Services are delivered through Functional Service Provision (FSP) models, fixed-cost project engagements, and full-service CRO arrangements.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels9 records

Core offering

Quanticate is a data-focused Contract Research Organisation (CRO) providing biometrics and clinical data services to pharmaceutical, biotech, and medical device companies. Core offerings include statistical consultancy, biostatistics, statistical programming (SAS/R with CDISC SDTM/ADaM), clinical data management, regulatory medical writing, and pharmacovigilance, supported by specialist capabilities in PK/PD analysis, AI/automation, real-world evidence, rescue studies, ISS/ISE submissions, and Functional Service Provision (FSP) delivery models.

Product overview

Quanticate is a data-focused Contract Research Organisation (CRO) providing a unified biometrics and clinical data services platform spanning the full drug development lifecycle. With over 30 years of industry experience, its core offering is built around six principal services — Statistical Consultancy, Biostatistics, Statistical Programming, Clinical Data Management, Regulatory Medical Writing, and Pharmacovigilance — supported by specialist add-on modules including PK/PD Services, AI and Automation, Clinical Data Visualizations, Real World Evidence, ISS/ISE Submissions, Rescue Studies, CDISC Services, Functional Service Provision (FSP), Centralised Data Solutions (CDS), Data Quality Oversight, Bayesian Methods in Clinical Design, and Clinical Trial Transparency. The platform is powered by the proprietary iQ portal technology for centralized data storage, visualization, and study-level metrics. Clients include emerging biotechs, mid-large pharma and biotechs, and medical device companies.

Differentiator

Problem solved

Functional benefit

Products and services

• Statistical Consultancy Expert statistical input for protocol development, study design, sample size calculations, SAPs, TLF specifications, and mock-ups, including adaptive, Bayesian, and complex trial support for pharmaceutical and biotech sponsors.
• Biostatistics Statistical analysis and reporting services covering protocol statistical review, randomisation and unblinding, DSMBs support, CRF statistical review, SAP and output shells, and CSR review and production for clinical trials.
• Statistical Programming SAS and R programming turning validated clinical trial data into submission-ready datasets, tables, listings, and figures, including CDISC SDTM/ADaM development, TLF production, ISS/ISE data integration, and data anonymisation.
• Clinical Data Management End-to-end clinical trial data capture, cleaning, and locking services covering database build and EDC setup, CDASH-compliant CRF/eCRF design, medical coding, query management, external data reconciliation, RBQM, and DMP development.
• Regulatory Medical Writing Creation of accurate, evidence-based clinical and regulatory documents throughout the drug development lifecycle, including clinical study reports, protocols, CTD summaries, investigator brochures, patient safety narratives, and scientific communications.
• Pharmacovigilance Patient safety protection and compliance services across clinical trials and post-marketing products, covering case processing, expedited reporting, safety database hosting and migration, DSUR/PSUR/PBRER/PADER support, and QPPV, RMP, signal, and device vigilance services.
• Functional Service Provision (FSP) Flexible resourcing model providing scalable external functional biometric teams that can be flexibly adjusted to peaks and troughs in sponsor pipelines, including governance structures between sponsor and CRO for long-term embedded partnerships.
• Centralised Data Solutions (CDS) Data-focused clinical data outsourcing approach combining clinical data management, biostatistics, clinical programming, medical writing, and pharmacovigilance elements, utilizing centralized data storage and visualisation technology (iQ) for optimal clinical and safety data management.
• PK/PD Services Specialist pharmacokinetics (PK) and pharmacodynamics (PD) analysis using dedicated software and expertise to support dose optimization and regulatory submissions for investigational drugs.
• Real World Evidence Generation of insights from real-world data sources such as electronic medical records, claims data, and healthcare databases to support health economics, outcomes research (HEOR), and observational studies.
• ISS/ISE Submissions Pooling of safety and efficacy data across multiple studies for regulatory submission, including planning of analyses and summaries, data submission planning, report creation, and production-stage issue mitigation.
• Rescue Studies Expert support to resolve data, compliance, resource, and technology challenges in struggling clinical trials, protecting study integrity and setting research up for success.
• CDISC Services & Mapping CDISC standards expertise including SDTM and ADaM mapping, annotated CRF development, define.xml 2.0 preparation, and Pinnacle 21 validation for regulatory submissions.
• AI and Automation AI-driven tools that accelerate statistical documentation and clinical reporting by automating SAP creation, table output conversion, and CSR generation, combining structured metadata, regulatory standards, and human expert review for faster, traceable, and submission-ready outputs.
• Clinical Data Visualizations Free pre-database-lock Tables, Listings, and Figures visualisations offering early insights into potential trial reporting results, supporting real-time oversight and data review.
• Data Quality Oversight Risk-based quality management and data oversight services ensuring data integrity, regulatory compliance, and efficient monitoring across clinical trial conduct.
• Bayesian Methods in Clinical Design Adaptive and Bayesian trial design support enabling optimally designed studies that can reduce costs and save time through smaller sample sizes or earlier trial stopping without wasted efforts.
• Clinical Trial Transparency Clinical trial transparency services covering lay summaries, clinical trial registration and result disclosures, and data and document anonymisation to meet regulatory requirements and improve public access to trial information.

Quantifiable outcome

• Clean quality clinical trial databases delivered through established governance structures
• +3 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature6 records

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Cytel: Cytel is a biostatistics and clinical data services CRO with deep expertise in statistical programming, adaptive trial design, and Bayesian methods, directly overlapping Quanticate's core biometrics offering for pharma and biotech sponsors.
• Statistics & Data Corporation (SDS): SDS is a biometrics-focused CRO offering biostatistics, statistical programming, and clinical data management to pharma and medical device sponsors, making it one of the most direct competitors to Quanticate's service portfolio.
• Rho: Rho is a contract research organization providing clinical data management, biostatistics, regulatory, and safety services to pharma and biotech, with comparable mid-market focus and biometrics-led service mix as Quanticate.
• Advanced Clinical: Advanced Clinical is a mid-size CRO offering clinical research, biometrics, and functional services to pharma and medical device sponsors, competing with Quanticate in data management and statistical programming.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-size CRO providing clinical development, biometrics, and pharmacovigilance services across all phases, with overlapping biostatistics and CDM offerings for pharma and biotech.
• Premier Research: Premier Research is a CRO serving biotech and specialty pharma with clinical development, biometrics, and medical writing services, comparable to Quanticate in mid-size segment targeting and biometrics specialization.

Broad incumbents

• ICON plc: ICON plc is a global full-service CRO with extensive biostatistics, programming, and data management capabilities. While much larger and broader than Quanticate, it competes for the same biometrics outsourcing budgets.
• IQVIA: IQVIA is the world's largest CRO with deep biometrics, real-world evidence, and technology capabilities. It competes with Quanticate at the high end of the biometrics outsourcing market while offering bundled full-service scale.
• Parexel International: Parexel is a global CRO with significant biometrics, biostatistics, and clinical data services capabilities, competing with Quanticate for biostatistics and programming engagements from mid-large pharma sponsors.
• Labcorp Drug Development: Labcorp Drug Development (formerly Covance) is a global CRO with substantial central laboratory, biometrics, and clinical development services, overlapping with Quanticate in CDM and biostatistics delivery for pharma sponsors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/quanticate
• YouTubeyoutube.com/channel/UC2HXpQ-7oaTQU9lp0hw8HGw
• Facebookfacebook.com/quanticate-141750183091
• LinkedInlinkedin.com/company/quanticate
• Instagraminstagram.com/Quanticate

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Quanticate