Data standards are a critical component in the quest to improve global public health. Inefficiencies in the collection, processing and analysis of patient and health-related information drive up the cost of research and development for life sciences companies as well as negatively impact the cost and quality of healthcare delivery for patients and consumers.

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Using CDISC Models to Analyze Drug Safety Data
Find out how CDISC standards for global, platform-independent data enable researchers to improve medical research and related areas of healthcare.

The solution is to leverage data standards like CDISC to provide more efficient and effective use of medical information by all members of the healthcare and life sciences ecosystem.

SAS CDISC participation
With a deep commitment to the development and implementation of data standards in life sciences, SAS has been a member and ardent supporter of CDISC since 2000. SAS' involvement in CDISC includes:

CDISC Board of Directors participation.
CDISC Industry Advisory Board participation.
CDISC Data Model Team participation for ODM, ADaM, SDS and CRT-DDS (define.xml).
Participation in strategic CDISC development initiatives such as the Biomedical Research Integrated Domain Group (BRIDG) model.
Interoperability demonstrations in software "connectathons."
Collaborations in CDISC Interchanges and other projects to explore the interoperability of CDISC data models.
Support of CDISC training and implementation activities.

SAS software support for CDISC standards
In addition to helping define CDISC standards, SAS is making certain that our products and solutions support the implementation of CDISC data standards. SAS®9 includes a component called PROC CDISC that enables organizations running SAS programs to work with CDISC structured data. PROC CDISC supports bi-directional conversion of data content contained in a CDISC ODM XML document to and from SAS-accessible data sources. The current version of PROC CDISC also supports content validation of SAS-accessible data sources to the CDISC SDTM data domain definitions. See www.cdisc.org for details on individual format descriptions.

CDISC standards such as SDTM, ODM, LAB and ADaM can be effectively implemented in solutions like SAS Drug Development and SAS DI Studio, and we're currently exploring additional ways that these standard processes and data structures can be utilized within our software.

The SAS XML Libname Engine has been enhanced in SAS 9.1.3 to natively read and write CDISC ODM file content. Using the SAS XML Libname Engine, any data content accessible to SAS may be converted to a CDISC ODM XML document, or conversely, any content in a CDISC ODM XML document may be converted to a SAS dataset or other SAS-accessible data source.

SAS CDISC implementation services
In addition to providing CDISC support within our software, SAS consultants are ready to help your organization implement CDISC standards to drive efficiencies in your clinical development processes.

Registered solution provider
SAS is recognized by CDISC as a CDISC Registered Solution Provider. Solution providers are qualified consultants, systems integrators and subject-matter experts believed by CDISC to have sufficient knowledge and experience implementing the various CDISC standards.

Glossary

ADaM Analysis Dataset Model

CDISC Clinical Data Interchange Standards Consortium

CRT-DDS Case Report Tabulation Data Definition Specification

LAB Laboratory Data Model

ODM Operational Data Model

SDS Submission Data Standards

SDTM Study Data Tabulation Model

XML eXtensible Markup Language

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SAS® and the Clinical Data Interchange Standards Consortium (CDISC)

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