ADaM Programming

ADaM defines dataset and metadata norms that support
• Effective generation
• Replication
• Review of clinical trial statistical analyses
• Traceable among analysis results, analysis & represented in the SDT Model.

As understood, ADaM is one of the required norms for data submission to FDA (USA) and PMDA (Japan). Details on the requirements for FDA are norms in the FDA’s Data Standard catalog for NDA, ANDA& certain BLA submissions

OTHER SERVICES

Biostatistics Services

Globally, the focus of the biopharmaceutical industry is on

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.

SDTM Programming

The SDTM process provides a standard for organizing & formatting data to

CDSIC Services

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

Pinnacle 21

K2SA Limited leverages Pinnacle 21 software for addressing

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,