SAS(R) Data Integration Server Gives Octagon Research Solutions, Inc. New Angle on Clinical Data.SAS (1) (SAS Institute Inc., Cary, NC, www.sas.com) A software company that specializes in data warehousing and decision support software based on the SAS System. Founded in 1976, SAS is one of the world's largest privately held software companies. See SAS System. Helps Octagon Convert Clients' Diverse Data into Standard Format for Submission to FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. CARY, N.C. -- When a new drug application is filed with the U.S. Food and Drug Administration (FDA) for review, millions of pieces of data about the drug development process and clinical trials accompany it. Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical research and development, helps drug-development companies of all sizes with this process. Octagon has turned to SAS, the leader in business intelligence, for powerful data integration technology to streamline the electronic submission process of its customers by helping them convert diverse data to the required standard format. "SAS has vast experience in the life sciences industry, and was a logical partner for us," said Octagon's Chief Information Officer David Evans David Evans may mean:
SDTM Straight Down the Middle (pinball wizard terminology) ." The Study Data Tabulation tab·u·late tr.v. tab·u·lat·ed, tab·u·lat·ing, tab·u·lates 1. To arrange in tabular form; condense and list. 2. To cut or form with a plane surface. adj. Having a plane surface. Model (SDTM) data standard was developed by the Clinical Data Interchange Standards Consortium Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization, whose mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of (CDISC CDISC Clinical Data Interchange Standards Consortium ). The FDA has requested in Guidance that all electronic data submitted for review adhere to adhere to verb 1. follow, keep, maintain, respect, observe, be true, fulfil, obey, heed, keep to, abide by, be loyal, mind, be constant, be faithful 2. this standard. The industry anticipates that in the future, the FDA will mandate use of SDTM. Having data presented in a standardized way improves the ability of FDA reviewers to evaluate the data and helps speed the approval and release of effective and safe new drugs. Octagon's pharmaceutical customers spend years gathering the data needed to prove the efficacy and safety of their drug compounds. This data is often from diverse systems and in varying formats. "Our clients big and small have been working on their studies for years and years. They want confidence that the data Octagon helps them submit adheres to all relevant standards like SDTM, and includes a complete audit trail to comply with regulations like 21 CFR CFR See: Cost and Freight Part 11," said Dan Crawford Dan Crawford may refer to:
21 CFR Part 11 refers to the Code of Federal Regulation issued by the FDA that mandates the criteria for trustworthy, reliable electronic records. SAS, a CDISC Registered Solution Provider, is committed to the development and implementation of data standards in life sciences and has been a CDISC member since 2000. SAS solutions such as SAS Drug Development and SAS Enterprise Data Integration Server support CDISC standards, and SAS consultants help organizations implement these standards. A major component of the SAS([R]) Enterprise Intelligence Platform, SAS Data Integration Server supports initiatives requiring data cleansing See address cleansing and data hygiene. and enrichment; data consolidation and migration; data synchronization Keeping data in two or more computers up-to-date so that each repository contains the identical information. Data in handheld devices and laptops often require synchronization with the data in a desktop machine or server. ; data warehousing See data warehouse. data warehousing - data warehouse ; and master data management. About Octagon Research Solutions, Inc. Octagon is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, Pa., with European headquarters in Amersham, UK. For more information, please visit www.octagonresearch.com. About SAS SAS is the leader in business intelligence software and services. Customers at 40,000 sites use SAS software to improve performance through insight into vast amounts of data, resulting in faster, more accurate business decisions; more profitable relationships with customers and suppliers; compliance with governmental regulations; research breakthroughs; and better products. Only SAS offers leading data integration, intelligence storage, advanced analytics and business intelligence applications within a comprehensive enterprise intelligence platform. Since 1976, SAS has been giving customers around the world THE POWER TO KNOW([R]). www.sas.com 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. [R] indicates USA registration. Other brand and product names are trademarks of their respective companies.[c] 2007 |
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