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 biometrics Contract Research Organisations.
Our Solutions
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
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
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
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
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
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
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
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.
Select your preferred resourcing model
Functional Service Provision
Gain rapid access to resource of functional biometric teams and become flexible to any peaks and troughs in your pipeline.
Fixed Cost Projects
Gain resource on a single project-by-project basis for the biometric support you need, when needed.
Meet our satisfied customers
“Quanticate is a clinical data expert and as a consultant I find they are easy to deal with, making my life much easier. Good communication and expectations management mean that we have built a good relationship over time which enables me to provide an excellent service to my clients in a timely and effective manner.”
