SAS Announces New Clinical Trials Technology

Dublin, Ireland, 02. Jul. 2007 -  SAS, the leader in business intelligence, today announced a new innovation in technology which will assist the speedy and accurate collation and assessment of data created during clinical trials. The new offering entitled SAS Drug Development provides a framework for gathering electronic health record (EHR) data into one centralised integrated system. SAS' new software will enable life sciences organisations make informed decisions by assessing the safety and efficiency of research compounds more effectively and collaborating across trials, phases and therapeutic areas successfully. This new technology adheres to the Clinical Data Interchange Standards Consortium (CDISC) regulations, the definitive independent medical and biopharmaceutical standards organisation.

SAS Drug Development allows researchers to more fully leverage electronic health record information in the clinical trial process for the first time. By gathering clinical research data in one central point 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 up 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 David McMahon, Client Director, SAS Ireland. "This framework helps provide the transparency and unambiguous path the Food and Drug Administration (FDA) is pursuing for all e-submissions and other required and related electronic source data. As a CDISC Registered Solution Provider, SAS is committed to the development and implementation of data standards in life sciences."

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 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. The new system 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. "Standardisation 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 FURTHER INFORMATION:
Siobhan Molloy/Louise Cassidy Tel: (01) 676 01 68
Weber Shandwick FCC or (086) 817 50 66 or (086) 383 57 27

About CDISC
CDISC is an open, multidisciplinary, non-profit organisation 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 organisations interested in streamlining biopharmaceutical product development and clinical data quality.

About SAS

SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration. Other brand and product names are trademarks of their respective companies.