Biometric CRO

Trusted by pharma & biotech for statistical & data expertise

Advance your pipeline with expert guidance, high-quality solutions, and trusted biometrics expertise. With over 30 years of experience, we ensure efficiency and data integrity at every clinical trial phase, accelerating your path to market.

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Our Biometric Services

Statistical Consultancy

Design smarter studies and make confident decisions with expert statistical input to reduce costs and save time.

Protocol development and study design
Sample size and power calculations
SAPs, TLF specifications and mock-ups
Adaptive, Bayesian and complex trial support

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Biostatistics

Prove efficacy and effectiveness with robust statistical analysis, clear reporting and regulatory-ready outputs.

Protocol statistical review
Randomisation and unblinding
SAPs and output shells
DSMBs support and setup
CRF statistical review
CSR review and production

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Statistical Programming

Turn validated clinical trial data into submission-ready datasets, tables, listings and figures.

SAS and R programming
CDISC SDTM/ADaM development
TLF production and quality control
ISS/ISE data integration and reporting
Data anonymisation

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Clinical Data Management

Capture, clean and lock high-quality clinical trial data so it is ready for analysis and reporting.

Database build and EDC setup
CDASH-compliant CRF/eCRF design and maintenance
Medical coding and query management
External data import and reconciliation
RBQM and DMP Development

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Regulatory Medical Writing

Create accurate, evidence-based clinical and regulatory documents throughout the drug development lifecycle.

Clinical study reports and protocols
CTD summaries and investigator brochures
Patient safety narratives
Scientific communications and document QC

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Pharmacovigilance

Protect patient safety and maintain compliance across clinical trials and post-marketing products.

Case processing and expedited reporting
Safety database hosting and migration
DSUR, PSUR, PBRER and PADER support
QPPV, RMP, signal and device vigilance services

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Why Quanticate?

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Industry Heritage

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Successful Studies

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Indications Experience

Global Locations

Our Areas of Expertise

Real World Evidence

Harness Real World Data from secondary sources—such as electronic medical records, claims data, and healthcare databases—to generate insights that support health economics, outcomes research (HEOR) and observational studies.

Rescue Studies

Get your clinical trial back on track with expert rescue study support. Quanticate helps resolve data, compliance, resource and technology challenges quickly, protecting study integrity and setting your research up for success.

EDC & Data Capture Options

Utilize the latest data capture technologies such as wearable and ePRO devices and take a flexible approach to selecting the right electronic data capture (EDC) system for your trial.

Clinical Study Designs/Adaptive Trials

An optimally designed trial can reduce costs and save time, either by requiring a smaller sample size or by stopping a trial earlier in time without continued wasted efforts.

AI and Automation

Accelerate statistical documentation and clinical reporting with Artificial Intelligence. Our tools support SAP creation, table output conversion and CSR generation, combining structured metadata, regulatory standards and human expert review to deliver faster, traceable and submission-ready outputs.

PK/PD Services

Get the specialist software and expertise you need to discover what the body does to your investigational drug and where it goes with Pharmacokinetics (PK) and Pharmacodynamics (PD) analysis.

Clinical Data Visualizations

Gain early insights into your pre-database lock data with free Tables, Listings and Figures visualisations to give you an idea of the potential trial reporting results that lie ahead.

ISS/ISE Submissions

Strengthen your regulatory submission with integrated summaries of safety and efficacy. Quanticate helps you pool data across studies, assess key trends and prepare clear, submission-ready outputs that support confident regulatory review.

Select your preferred resourcing model

Functional Service Provision

Gain rapid resources with external functional biometric teams that can be flexibly scaled to any peaks and troughs in your pipeline.

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Fixed Cost Projects

Receive resources on a single project-by-project basis for the biometric support you need, when needed.

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Meet our satisfied customers

Quanticate is one of the best CROs I have worked with in the past and they are really outstanding at biometrics. We have a great relationship; they're helpful and take the time to understand our needs. I would recommend [Quanticate] to anyone looking for any biometrics support.

Quanticate is a clinical data expert and consultant that I found easy to deal with. We've built a good relationship over the years which enabled [Quanticate] to provide excellent service to my clients in a timely and effective manner.

I would like to thank all of you for the fantastic support and help on SDTM mapping, TLFs creation, patient profiles, Pinnacle 21 set up & validation, BIMO submission package, eSUB submission packages, GDMS publishing, and pTMF filings! All of you are my superheroes!

“Quanticate is one of the best CROs I have ever worked with in the past and they are really outstanding at biometrics. Quanticate supported us with the analysis of a large phase 3 study, an integrated summary of efficacy and interactions with regulatory authorities. We have a great relationship with Quanticate at Fertility Biotech; they’re helpful and take the time to understand our needs. I would recommend them to anyone looking for any biometrics support.”

Don’t let your data let you down

Bring your drugs to market with fast and reliable access to experts from one of the world’s largest global biometric Contract Research Organisations.

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