SME Data Tech Solutions Inc

About Us

SME Data Tech provides biostatistics & statistical programming services to its clients in the entire clinical development cycle protocol development, study design, statistical analysis, and regulatory submission. Trained and competent professionals at SME Data Tech are well equipped to provide insightful analysis and reporting of clinical study data that enables clients to draw inferences and make well-informed decisions.
With global presence and team of expert biostatisticians and SAS programmers, SME Data Tech is uniquely positioned to provide a wide range of biostatistics and statistical programming services to our clients in a space where timely delivery and accuracy is of paramount importance.

Statistical Input to Protocol/Study Design Development
Sample Size Estimation
Randomization Schedule
Review of CRF and Data Management Plan
Statistical Analysis Plan (SAP) and Mock-up Shells
Analysis of Safety, Efficacy Data for CSR and Regulatory submissions
SAS Programming – SDTM/Adam Datasets and Tables, Listings, Figures
Design and Deployment of System-level SAS Macros
PK/PD Analysis
Integrated Safety and Efficacy Analysis (ISS/ISE)
Analysis for BA/BE Studies, Meta Analysis
CDISC Implementation Service
Support Safety Monitoring, Interim and Exploratory Analysis, Manuscripts and Abstracts
Patient Profiles/Safety Narrative
Statistical Report Writing