SAS Institute to Develop Clinical Data
Warehouse Aimed at Improving Clinical Data Flow
ACTION ITEMS
SAS Institute Inc. announced that it is creating a clinical data warehouse -- adding to a suite of Institute products aimed at pharmaceutical R&D. The clinical warehouse is being built on top of the Institute's SAS/Warehouse Administrator software, which builds and maintains data warehouses, to accommodate the special rigors of submitting new medical products for regulatory approval. The goal is to automate the flow of data between clinical information systems and analysis and reporting systems. One reason: so researchers can spend more time studying new products' safety and effectiveness and less time manipulating data. Another: to reduce costs associated with producing today's huge regulatory submissions.
SAS Institute's clinical data warehouse can help pharmaceutical and biotechnology companies improve productivity and to comply with regulatory requirements for submissions. This matters because the FDA and other regulatory agencies are moving toward paperless submissions. These new capabilities are part of SAS Institute's PharmaTechnology Process model, a method for improving the performance of clinical information systems. They are on exhibit through Thursday at the Drug Information Association annual conference in Boston.
"Our goal is to change the way drug and medical-device companies work by eliminating the traditional bottleneck between clinical data management systems and clinical data analysis tools," said Michael Roberson, program manager of PharmaHealth Technologies at SAS Institute, a business unit devoted to developing tools to assist in medical-products development. "The clinical data warehouse extensions will provide industry-specific functionality by creating a knowledge-management model aimed at speeding the movement of data through the complexities of clinical R&D and to the regulatory agencies. We're working to make sure everyone involved in the review process gets the data they need, in the form they require."
The pharmaceutical industry is a highly competitive global market characterized by stringent regulatory controls and long product development cycles. For every thousand new chemical entities that are investigated, only a handful are approved as new products. Successful products require enormous amounts of information to be delivered to the regulatory agencies. Productivity improvements in the review of clinical data can have profound financial -- implications --- the Wall Street Journal has reported that for many high-profile drug projects, the potential loss for each day a new product is delayed is often $1 million or more.
Data collected from clinical trials represent an organization's collective knowledge about a new drug or medical device's safety and efficacy. A company's ability to bring safe, effective new medical products to market as quickly as possible hinges on how well it uses this knowledge.
The SAS PharmaTechnology Process, developed as a result of working closely with a number of pharmaceutical and biotechnology companies, is a technology architecture and product suite created to improve clinical data systems' efficiency. It offers drug-development companies a way to integrate and streamline several key application areas within clinical R&D. The clinical data warehouse sets the stage by streamlining and documenting the flow of data and metadata from clinical data management systems, such as Oracle Clinical, into analysis and reporting systems, such as SAS/PH-Clinical software. The PharmaTechnology Process product suite also provides:
SAS/PH-Clinical software, a solution for reviewing, analyzing and reporting clinical trials data, has been recently updated with improved data browsing, production batch reporting, a toolkit for custom viewer creation, and the ability to publish resulting output to either an intranet or an enterprise document management system. The new Autoload Manager allows for the rapid movement of clinical data from the clinical data management system into the reporting and review environment, eliminating a traditional bottleneck in the process.
Because sharing information is a vital part of studying new medical products and preparing a well-organized regulatory submission, publication of output to intranets is possible from within SAS/PH-Clinical software and via the Institute's Web publishing technology, SAS/IntrNet software.
Now in its 22nd year, SAS Institute is one of the top ten largest independent software vendors in the world, and is the largest privately held software company. SAS Institute provides an integrated suite of information-delivery tools that allow companies to transform the wide variety of data within their organization into information that business users need to make decisions. To make data useful, SAS software collects data from almost every platform and data format; cleans and transforms data into information that users will understand; and stores that information in an open and efficient data warehouse structure. To explore that information, SAS software includes OLAP, query and reporting, EIS, data mining, analysis, data visualization, and application-development interfaces.
For more information, see http://http://www.sas.com