SAS pioneers support for CDISC standards to access electronic health record (EHR) data

ATLANTA  (June 18, 2007)  –  SAS, the leader in business intelligence, today announced the expansion of the company’s efforts to support standards established by the Clinical Data Interchange Standards Consortium (CDISC), the definitive independent medical and biopharmaceutical standards organization. 

SAS is helping to drive the revolution in clinical research by developing a framework for loading electronic health record (EHR) data into SAS® Drug Development using CDISC standards, allowing researchers for the first time to more fully leverage EHR information in the clinical trial process. By gathering clinical research data one time at the point of care, researchers can reduce data errors, save time and enable rapid clinical data availability, leading to better, faster clinical development decisions. This new framework can speed clinical research and enable better medicines to get to market faster. 

“Strong and efficient interfaces that link electronic health records with the pharmaceutical industry and regulatory authorities will enhance public health by improving both therapeutic product safety and efficacy,” said Edward Helton, PhD, SAS’ Chief Strategist of Regulatory and Biomedical Affairs, who also serves as the Chair-Elect of CDISC’s Board of Directors. “This framework helps provide the transparency and unambiguous path the FDA is pursuing for all e-submissions and other required and related electronic source data.” 

At the HIMSS07 Annual Conference & Exhibition this spring, CDISC and Integrating the Healthcare Enterprise(IHE) led a first-of-its-kind demonstration showing how healthcare data could be extended into pharmaceutical research and surveillance. Five use-case scenarios demonstrated how clinical data can be transferred seamlessly in the CDISC ODM XML format between EHR systems and solutions used for clinical research, patient registries, safety surveillance and disease outbreak surveillance. 

SAS Drug Development served as the catalyst in these transfers, where it was also used as an engine for creating analysis-ready data sets and generating safety reports. Ultimately, SAS Drug Development was a key in speeding up the entire process over traditional, manual processes commonly employed today.

“Recent Gartner research clearly demonstrated how industry standards can produce many significant clinical and business benefits for all parties involved in the development of new treatments,” said Carol Rozwell, Vice President and Distinguished Analyst, Gartner, Inc. “Standardization will increase data quality; improve science, marketing and safety surveillance through enhanced data integration; reduce the cost and effort in sharing data within the clinical study value network; accelerate decision making by improving project team communication; enable consistency; and facilitate regulatory review.” 

For many years, SAS has made valuable contributions to CDISC’s efforts in developing international standards. As a CDISC Registered Solution Provider, SAS is committed to the development and implementation of data standards in life sciences. SAS solutions such as SAS Drug Development and SAS Enterprise Data Integration Server support CDISC standards, and SAS consultants help organizations implement these standards. 

SAS has been a CDISC member since 2000 and supports CDISC by serving as a corporate sponsor and participating in various technical and advisory teams. 

SAS will have further information on its support for CDISC standards in booth #215 at the Drug Information Association’s (DIA) 43rd Annual Meeting, June 17-21, 2007 in Atlanta. 

About CDISC

CDISC is an open, multidisciplinary, non-profit organization committed to developing and supporting global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available. 

CDISC is made possible through the generous support of its members, sponsors, and volunteer participants. These include academia, biopharmaceutical companies, technology and service providers, Health Level Seven and other organizations interested in streamlining biopharmaceutical product development and clinical data quality. 

Additional information on CDISC can be found on the CDISC website. 

About SAS

Back to Recent SAS Press Releases

Copyright © SAS Institute Inc. All Rights Reserved.