Biometrics
Statistical Programming
A strategic and tailored approach to your statistical analysis and reporting for on time and high quality deliverables
Successful submissions to regulatory authorities require an experienced team with in-depth knowledge of statistical analysis, CDISC data standards, and agency submission requirements. Access our team of experienced Statistical Programming experts, robust quality procedures, and automated deliverable processes to accelerate your reporting and submission with maximum quality.
Our Services
- Programming of Analysis datasets
- SEND, SDTM, and ADaM dataset programming
- Creation of supportive CDISC deliverables e.g., Define.xml and Reviewer’s guides for your FDA and PMDA submissions
- Statistical Programming of outputs: Tables, Figures, and Listings
- Support for full-service projects or ad-hoc requirements
- Review of datasets and deliverables to ensure CDISC compliance
- Conversion of legacy studies to CDISC standard
- Regulatory submission support, e.g. preparation/presentation of Study Data Standardization Plans to FDA
- ISS and ISE: planning and delivery of integrated CDISC datasets and statistical results
- Key safety reporting including PSUR and DSUR
- Creation of individualized standards for your portfolio of studies (library of macros & tools, standard CRFs, TFL shells)
Why choose us for Statistical Programming?
- Robust SOPs audited more than 10 times per year by clients
- Statistical Programming team based in Europe and North America
- CDISC Gold member supporting 3 to 5 CDISC electronic submissions each year
- >75% of statistical programmers with a Master of Science in statistics
- 100% on-time delivery of ISS/ISE in previous five years