Our Services

Over years we have developed a cohort of SAS programs and macros that can be used in producing statistical reports, tables, listings, and figures (TLFs) that are customarily included in IND, NDA and BLA submissions to the FDA, and in support of DSMB meetings. These SAS programs can be quickly implemented to keep programming development time down, facilitate QC/validation, and get submission-ready outputs to clients.

Scope of Services

Our services focus on SAS programming support and solution for phase I through phase IV clinical projects including, but not limited to, the following:

ADaM and STDM datasets creation, and data specifications development in compliance with CDISC standards
Creating integrated database supporting ISS (Integrated Summary of Safety) required for regulatory submissions
Mapping and validating, or enhancing client’s existing ADS in order to meet CDISC requirements
Development of table shell (mock tables) according to Statistical Analysis Plan (SAP) or Reporting and Analysis Plan (RAP)
Full production of analysis summaries, tables, listings and graphs for individual trials, either final analysis or interim analysis
Full production of ISS (Integrated Summary of Safety) summaries, tables, listings and graphs
Development of SAS macros customized to client’s specifications
Any emerging or ad-hoc requests for SAS programming

Service Models

On-Site Consulting
Off-Site Leasing Contractor
CRO (Outsourcing)
Off-shored Outsourcing