Trusted by pharma & biotech for statistical & data expertise
Advance your pipeline with expert guidance, high-quality solutions, and trusted biometrics CRO expertise. With 30 years of experience, we ensure efficiency and data integrity at every phase, accelerating your path to market.
Our Solutions
Consulting
Our consulting services in clinical development focus on scientifically sound statistical protocol design. Leveraging both Frequentist and Bayesian statistical framework, we enable clients to optimize study power, adaptive features, and operational feasibility. Our expertise ensures regulatory compliance and strengthens the statistical integrity of your trials, improving the likelihood of approval.
Clinical Trial Services
We offer expertise, resources and services in Statistics, Statistical Programming, Clinical Data Management, Pharmacovigilance, and Medical Writing to ensure quality and data integrity in clinical trials. Our approach streamlines processes across studies and portfolios, improving efficiency and decision-making. We also deliver prompt solutions for rescue studies, stabilizing underperforming trials and ensuring data quality and successful delivery.
ISS/ISE Submissions
We specialize in providing expert support for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy/Efficiency (ISE), ensuring data standardization and regulatory compliance to accelerate submission and approval processes.
AI and Automation
We integrate AI and automation throughout our processes to drive speed, efficiency, and quality. One example is QSummarise, our SDTM dataset automation tool, which automates data extraction, mapping, and CDISC standard translation. From the eCRF, the solution seamlessly integrates annotated mappings, generates adaptable SAS code, and ensures define.xml readiness. Our evolving tools manage 80-95% of complex mappings, balancing automation with expert oversight to streamline clinical research and accelerate data submission. For more information on how our AI and automation tools can benefit your clinical research, please contact us.
Post-Marketing Safety and Pharmacovigilance
We deliver expert post-marketing safety services, including adverse event management, risk assessments, and regulatory reporting. Our team ensures ongoing patient safety and product integrity throughout the lifecycle.
Real World Data
We harness Real World Data from secondary sources—such as electronic medical records, claims data, and healthcare databases—to generate insights that support health economics and outcomes research (HEOR). Our specialist team supports sponsors with observational studies and post-approval safety research, enabling evidence-based decision-making, value demonstration, and regulatory submissions.
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.”
