Accurate insights for successful regulatory approval.
We create fully compliant, submission-ready SDTM and ADaM datasets and produce high-quality tables, listings, and figures (TLFs) that clearly communicate the safety, efficacy, and outcomes of your trial. We adapt to the way you work, integrating seamlessly with your team to provide the expertise, flexibility, and quality control needed for regulatory success.
Our statistical programming expertise covers every stage of clinical development, including:
CDISC Compliant SDTMs and ADaMs
Build fully compliant datasets to streamline regulatory review and approval.
CRT submissions (aCRF, define.xml and reviewer’s guides)
Deliver complete, accurate submission packages to meet global regulatory standards.
P21 Enterprise validation
Ensure datasets meet compliance requirements through rigorous validation checks.
Tables, Figures and Listings
Produce clear, accurate outputs, in customizable formats, that communicate the study results efficiently and effectively
Legacy data conversions
Convert legacy datasets into modern, compliant formats for seamless integration and submission.
Integrated datasets for ISS / ISE
Combine data across studies to support comprehensive integrated safety and efficacy summaries and analyses.
Data Visualizations
Create compelling visual representations of your study data, tailored to highlight key patterns, trends, and outcomes. Our statistical programming expertise ensures that every visualization is accurate, insightful, and ready for effective communication with stakeholders and regulators.
A proven track record delivering high-quality CDISC datasets and outputs for submissions, backed by experience across diverse therapeutic areas, countries, study phases, and complex designs.
Use of automation, R, and open-source tools to accelerate timelines while protecting quality.
Robust QC processes and independent review on every delivery, to ensure accuracy, traceability, and audit-readiness.
Active involvement in CDISC keeps us at the cutting edge of innovation, evolving standards, and regulatory requirements.
Friendly, easy-to-work-with teams who embed themselves in your processes for smooth day-to-day operations.
We have experience in statistical programming across a wide range of therapeutic areas, particularly oncology, respiratory and rare diseases.
Tailored data management solutions enabling you to deliver submission-ready data with confidence.
Getting the right evidence, at the right time, in the right format to make the right decisions.
Seamless compliance, efficiency, and innovation through expert governance, advanced automation, real-time visualisation, and AI-powered solutions.
