STATECS LLC

Biotech and pharmaceutical research sectors cannot do without statistical programming. The latter helps make large volumes of complex medical data interpretable for further use and implementation in biostatistical analysis.

At STATECS our experienced statistical programmers create high-quality software that collects, analyzes, and reports various types of data thus highly simplifying and facilitating the overall clinical trial procedures. This becomes possible through the production of regulatory submission-ready analysis datasets and Tables, Listings, and Figures (TLFs) which further assist in the determination of the safety and efficiency of drugs and products under investigation.

Our statistical programming services include:

● SAS and R programming

● Macro production, validation, and optimization

● Interim analysis support

● Annual clinical trial safety updates

● CDISC mapping/conversion possibilities

● CDISC ADaM submission-ready dataset development and QC for submission compliance

● Support and mapping of safety data for Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB), Safety Committee and Endpoint Committee

● Analysis Datasets and TLFs Development, and QC for standard studies and Integrated Summaries