our services
SEND DATASETS
Creation of Standard for Exchange of Nonclinical Data (SEND datasets) to regulatory submissions. We develop submission ready SEND datasets compliant with SENDIG v3.0/3.1/3.1.1, DART 1.2 and SENDIG-GeneTox v1.0
SDTM MAPPING
Clinical study raw data mapped to SDTM for all trial phases (I to IV). Generation of Study Data Tabulation Model (SDTM) datasets for clinical trial data submission
Clinical TLFs
Regulatory-quality Tables, Listings, and Figures generated using validated SAS macros and submission-ready formats
Why Choose Us?
Perfection Anytime
We provide accurate, submission-ready datasets that meet global regulatory standards, reduce submission delays, and ensure faster approvals for our clients.
Advance Technology
CDISC standards: SEND, SDTM, ADaM SAS-based TLF outputs for clinical study reports, Pinnacle 21 validation, SAS, R, DefineXML, NIMBLE, and JReview.