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Trusted by pharma & biotech for statistical & data expertise

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

Our Solutions

Clinical Development Planning & Protocol Innovation@2x

Clinical Development Planning & Protocol Innovation

Our advanced clinical development services include meticulous planning and innovative protocol design. We leverage both traditional and Bayesian methodologies to optimise trial efficiency and success. This strategic approach ensures robust study designs that meet regulatory requirements and enhance the likelihood of successful outcomes, providing a solid foundation for your clinical trials.

Clinical Trial Execution & Efficiencies@2x

Clinical Trial Execution & Efficiencies

Our biometrics and data expertise ensure precision in trial execution. We streamline data processes, consolidating trial, program, and portfolio data for maximum efficiency. Our capabilities in rescue study execution provide rapid and effective interventions to keep your trials on track, ensuring timely and accurate results. This holistic approach optimises every aspect of a clinical trial, from meticulous data handling to strategic interventions, driving successful and efficient study completion.

Data Standardisation and Analysis@2x

Data Standardisation and Analysis

We ensure the seamless integration, uniformity and compliance of your clinical data to enhance data presentation and streamline your trial outcomes. Through CDISC Mapping, we transform complex data sets into standardised formats, facilitating regulatory compliance and enhancing data usability. Our team of specialists then provide meticulous support for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) services, supporting essential regulatory submissions and accelerating approval processes.

Data Automation@2x

Data Automation

We automate the creation of SDTM datasets for our clients with speed, efficiency and quality. Starting from the eCRF in Clinical Data Management, we streamline data extraction and mapping, ensuring accurate CDISC standard translation. Our process integrates annotated mappings into specifications, generating adaptable SAS code. With define.xml readiness, we efficiently produce necessary documentation. Our evolving tools handle 80-95% of mappings, even in complex studies, balancing automation with expert oversight, enabling faster and more streamlined clinical research

Data Visualisation and Analytics@2x

Data Visualisation and Analytics

Utilising our advanced and in-depth analytical expertise, we turn complex data into clear, actionable insights. Using our interactive TLF platform, we provide near-real-time reports on key metrics like demographics, adverse events, and vital signs. Our tools identify outliers and potential issues, facilitating quick corrective actions and improving data quality. Our optimised approach enhances decision-making and ensures efficient trial management. 

Real World Data@2x

Real World Data

We leverage Real World Evidence (RWE) to provide actionable insights into drug safety, efficacy, and economic outcomes. Our specialist team handles diverse data sources like EMRs, wearables, and healthcare databases to support regulatory submissions and enhance patient care. We specialise in observational studies, pragmatic trials, post-approval safety studies, and more. 

Delivery Models@2x

Delivery Models

As a Functional Service Provider (FSP), we provide scalable, expert resources tailored to your needs, ensuring high-quality and timely deliverables with rapid scaling and seamless integration with your in-house teams. For specific project requirements, our project quote-based services deliver precise, cost-effective solutions.

Therapeutic Areas & Phases@2x

Therapeutic Areas & Phases

We support a broad range of therapeutic areas, including oncology, cardiovascular, and rare diseases, ensuring tailored solutions for each study. Our expertise spans all clinical trial phases, from early Phase I studies to post-marketing Phase IV trials. We provide comprehensive services that adapt to the unique requirements of each therapeutic area and phase, leveraging our specialised knowledge to enhance trial efficiency and success. 

Why Quanticate?

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Industry Heritage

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Successful Studies

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Indications Experience

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Global Locations

Our Areas of Expertise

Protocol Design and Power Calculations

Get the right protocol design for the right scientific questions of your trial and boost the chance of success with sound sample size calculation.

CDISC/ADaM Mapping

Convert all your trial research data into one globally regulatory recognized data standard for clinical research.

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.

ISS/ISE Support

Overcome the challenges of combining multiple studies to review the safety and efficacy of an IND/NDA.

Centralized Statistical Monitoring & Data Quality Oversight

Help assure that your regulatory submission isn’t needlessly delayed through a lack of data quality or integrity as you discover data anomalies, outliers and other unnoticeable trends to improve the chance of your regulatory approval.

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.

Clinical Trial Reporting

Unlock the insights from your data with in-depth reports designed ready for regulatory submissions.

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 visualizations to give you an idea of the potential trial reporting results that lay ahead.

Oncology

Oncology trials face many challenges in the collection, analysis and reporting of study data, and selecting a partner that is specializes in data instead of a traditional full-service CRO can make all the difference in your studies success.

Select your preferred resourcing model

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Functional Service Provision

Gain rapid access to resource of functional biometric teams and become flexible to any peaks and troughs in your pipeline.

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Fixed Cost Projects

Gain resource on a single project by project basis for the biometric support you need, when needed.

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Meet our satisfied customers

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.