SDTM Programming

The SDTM process provides a standard for organizing & formatting data to streamline processes in collections, management, analysis & reporting. By implementing SDTM, K2SA achieves for the biopharma industry,

The benefit of,
• Providing data aggregation and warehousing
• Foster mining and reuse
• Facilitate sharing and help perform due diligence
• Improve the regulatory review & also approval process

Our support services are provided to non-clinical data, medical devices and pharmacogenomics studies. Study Data Tabulation Modelis one of the required standards for data submission to FDA (USA) and PMDA (Japan). We understand the vital and sensitive aspects of Study Data Tabulation Model (SDTM) for the global biopharmaceutical industry.

OTHER SERVICES

Define XML

To describe any tabular dataset structure Define XML is used as it helps

Statistical Programming

During our collaboration withDrug Company or a research organization,

SAS Programming

Our SAS technical engineers play an important role as part of the

Clinical research Staffing

The best & most efficient personnel are primary for any business is success.

Biostatistics Services

Globally, the focus of the biopharmaceutical industry is on

ADAM Programming

ADaM defines dataset and metadata norms that support

Pinnacle 21

K2SA Limited leverages Pinnacle 21 software for addressing

CDSIC Services

CDISC in the process to amplify data’s impact, CDISC helps to drive