SAS Programmers transform, analyze and report on clinical trial data.

We collaborates with the pharmaceutical industry to enable accessibility, interoperability, and reusability of data for more meaningful and efficient research that has greater impact on global health.

OUR SERVICES : 

• Provide statistical programming support for Phase I to Phase IV clinical studies.
• CDISC standards – SDTM and ADaM implementation and programming as a part of
  regulatory submissions.
• Create programming specifications for SDTM and ADaM datasets.
• Programming and validate SDTM and ADaM datasets, tables, listings and figures.
• Pinnacle 21.
• Define.xml.
• aCRF annotation

CDISC SERVICES:

We offers the needful expert advice on all aspects of CDISC therapeutic area standards. This includes,

• Guidance on which domains and datasets to use in collecting and storing data
• Guidance on which variables to use to represent data items
• Guidance on the definition of non-standard (supplemental) variables, when the
  currently defined standard variables are insufficient for the task
• Guidance on relating data across domains and datasets

SDTM PROGRAMMING :

SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. By implementing SDTM, we achieves for bio-pharma industry the benefits of,

• Provides data aggregation and warehousing
• Fosters mining and reuse
• Facilitates sharing and helps perform due diligence
• Improves the regulatory review and approval process.

ADaM PROGRAMMING:

ADaM defines dataset and metadata standards that support

• Efficient generation
• Replication
• Review of clinical trial statistical analyses
• Traceability among analysis results, Analysis data, and data represented in the Study Data Tabulation Model (SDTM)
• As understood, ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submission.

PINNACLE 21:

Pinnacle 21 software for managing CDISC compliance, clinical data quality, and FDA submission readiness. As understood, Pinnacle 21 Enterprise, is used by the FDA (under the name “DataFit”) to screen incoming submissions.

DEFINE-XML:

Define-XML is prescribed by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). It is used for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.