SAS INSTITUTE DELIVERS PHARMATECHNOLOGY PROCESS

SAS Institute Inc., a leader in decision support for clinical R&D, has announced that the SAS PharmaTechnology Process -- a technology architecture created to make the clinical research processes more efficient and productive -- will be generally available during fourth quarter 1998. Applying data warehouse technology specifically to the field of clinical research, this unique model includes Web-enabled publishing and reporting systems and a broad range of client-side viewers for specific tasks within the clinical-research process.

The goal: to speed safe new medicines and healthcare products to market by allowing biotechnology, pharmaceutical, and medical-device companies to focus on creating new products, rather than on developing software.

"The SAS PharmaTechnology Process model evolved as a result of SAS Institute working closely with a number of pharmaceutical and biotechnology companies," said Lee Evans, director of SAS PharmaHealth Technologies, a new business unit established to provide technology and services aimed at improving clinical and health research. "Moreover, SAS software is a common technology thread throughout the pharmaceutical industry and the regulatory agencies. So we're in an excellent position to help these organizations realize substantial efficiency improvements. Our approach calls for examining tasks to be performed and designing a system for performing those tasks, based on scientific and business needs as well as appropriate technology. Our solution was created to help clinical data flow smoothly from data entry through publication, submission, and post-marketing studies."

The SAS PharmaTechnology Process is the first in a series of technology models from SAS PharmaHealth Technologies. For the pharmaceutical industry, the PharmaTechnology Process begins with clinical data management and ends with the publication of data for regulatory submission and post-marketing activities. Along the way, it overcomes five formidable bottlenecks that hamper the traditional approach to clinical data management, review, analysis and publication. These bottlenecks occur:

--at the point of moving data from the clinical data management system to the reporting and analysis structures

--in the management of the data transformations, which are needed to turn the raw data tables into analysis ready structures, which are so important to all clinical research activities

--in making the clinical data available to all clinical R&D team members regardless of their technical skills, and enabling specialized or in-house software applications or Web-based systems to run seamlessly with that data

--in the management and validation of software used for transformations, reporting and analysis

--in the management and validation of the output (and its associated documentation) that will be published with internal and regulatory submission documents.

To remove these bottlenecks, the SAS PharmaTechnology Process provides software components and technologies within a two-part model -- the PH.DataWare System (data-deployment servers) and the PH.InfoWare System (data-exploitation clients). The process achieves efficiencies by reducing the number of tasks in a system, automating tasks previously done manually, and migrating from paper to electronic systems. Specific components include: interactive and non-interactive reporting features, opportunity for integration with document-management systems, an import facility to offer a wider range of data access, and specialized GUIs (a.k.a. viewers) tailored to the different functions -- such as clinical data review and patient data browsing. The process' clinical warehousing environment has an interpretive layer that " feeds" the desktop viewers information in whatever form reviewers need.

The process has an open and flexible technology platform to deal with the complexity of clinical data review and submission preparation. To this end, the process' software components integrate with other software applications, such as Oracle Clinical, document publishing systems, and image viewing applications. "Previously, these systems were not integrated through a cohesive process," Evans said. "This integration gives research organizations the ability to understand and control the methodology, workflow, and processes for clinical data management and review."

Because implementations of the SAS PharmaTechnology Process are unique, prices are flexible depending on the specific software and services components deployed. The process accommodates multiple system hardware platforms. Server-side clinical data handling systems operate on various UNIX environments and on NT environments. Client viewers and applications can also be run across various UNIX and Windows-compliant platforms. Some PharmaTechnology Process components may be designed to exploit native capabilities in the Windows environment for client-side computing.

For more information, see http://www.sas.com