CDISC Gold Member
We are at the forefront of CDISC standards (like SDTM and ADaM) for regulatory submissions, even contributing to their improvement.
Comprehensive SDTM Services
From developing new SDTM datasets to converting legacy data, we ensure your data meets the highest regulatory standards.
Rigorous SDTM Processes
We follow detailed steps with quality control at every stage, from data mapping to submission package creation.
Expert ADaM Development
We create analysis-ready ADaM datasets based on your statistical plan, ensuring seamless analysis.
Thorough ADaM Processes
Similar to SDTM, our ADaM development includes meticulous mapping, programming, validation, and quality checks.
Advanced Data Cleaning
We utilize SAS edit checks to identify and resolve data issues beyond standard EDC system capabilities.
Regulatory Submission Expertise
We have a proven track record of producing high-quality submission documents, including define.xml and reviewer's guides. Our TLF templates have been accepted by the FDA in NDA submissions.