End-to-End Statistical Programming Services
SDTM -> ADaM -> TLFs
SDTM -> ADaM -> TLFs
SDTM -> ADaM -> TLFs
We work with our clients to create CDISC compliant SDTM (including aCRF per FDA guidelines), ADaM datasets as well as TLF (Tables, Listings and Figures) outputs for Phase I to IV clinical studies in various therapeutic areas.
Define Package
SDTM -> ADaM -> TLFs
SDTM -> ADaM -> TLFs
We provide our clients with submission ready define package containing CDISC compliant datasets in xpt format, define.xml, reviewer's guide (csdrg, adrg) and any other associated documents such as aCRF, Pinnacle 21 validation report, specifications, etc.
SEND
SDTM -> ADaM -> TLFs
SEND
We have expertise to create CDISC compliant SEND dataset and corresponding define package for non-clinical studies.