Our programming team provides comprehensive service support throughout all stages of clinical development to improve data quality, optimize results, and reduce risks.
Development of submission-ready datasets and supporting documents in CDISC format: Annotated CRF, SDTM, ADaM, Define.xml and Reviewer’s Guide
Tables, Listings, and Figures Development and Quality Control
Data Monitoring Committee (DMC), Safety Committee and Interim Analysis Support
Generation of pooled datasets and TFLs for Integrated summary of efficacy and safety (ISE/ISS)
Rapid regulatory response outputs
Pharmacokinetic and pharmacodynamic data analysis and modeling.
Annual Clinical Trial Safety Updates(investigator brochures, DSURs etc.)
Support of patient profiles & ad-hoc reports, as well as data review and monitoring tools such as Tableau or R Shiny
Office of Scientific Investigation (clinsite.xpt, define.xml,reviewers guide, and OSI listings)
Functional Service Provider Solutions