SAS Drug Development sets the standard for clinical trials information management and analysis

April 11, 2005

Applied Clinical Trials

Launch of SAS Drug Development 3.0 provides unmatched insight into clinical trials through powerful data integration and analysis

PHILADELPHIA (April 11, 2004) -- Bringing new therapies to market is extraordinarily complex, with clinical trials data scattered among different systems throughout life sciences research organizations and new data arriving almost continuously from electronic data capture (EDC) vendors, contract research organizations (CROs) and other research partners.

At the same time, costs are escalating, budgets are tightening and the pressure from regulatory agencies, shareholders and consumers has never been greater. It is imperative that life sciences executives make intelligent decisions quickly and efficiently, and they can only do so if they have the utmost confidence in their clinical, data management and biostatistical information and processes. How can life sciences companies fully integrate and analyze their research for regulatory submission, and identify new market opportunities and product line extensions -- all while addressing potential safety issues more efficiently and effectively?

SAS, the leader in business intelligence, today announced the introduction of SAS Drug Development 3.0, software that leverages the breakthrough capabilities of the SAS9 Intelligence Platform to remove the obstacles in sharing data and applications across organizations and deliver the foresight and understanding required to succeed. Available as a standalone or hosted solution with access via a secure, thin client, SAS Drug Development provides a centralized repository that allows life sciences firms to analyze their clinical research for regulatory submission and explore new market opportunities, product line extensions and safety issues -- all within a controlled and secure collaborative framework designed for life sciences research industries. SAS Drug Development has been designed to meet federal regulations such as 21 CFR Part 11, good industry practices and sound business practices.

"SAS Drug Development integrates a number of key capabilities into a single, compliance-enabling solution for managing, analyzing and exploring clinical data," said Judy Hanover, senior research analyst for IDC's Life Science Insights. "By making the research content from locations across the organization available to trial managers, clinicians and biostatisticians, and embedding tools designed for each type of user, SAS Drug Development provides a unique offering to the life sciences research industries companies. When SAS Drug Development is used in conjunction with data from third-party sources like EDC, laboratory and safety systems, users can conduct the statistical analysis required for techniques like adaptive trials, signal detection and pharmacovigilance."

Merck evaluates SAS Drug Development for improved analysis and reporting
Established in 1891, Merck & Co., Inc. is a global, research-driven pharmaceutical company with nearly $23 billion in worldwide sales, and the company has been a SAS customer since the early 1980s. Like most companies in the ultra-competitive pharmaceutical industry, analysts in Merck's Biostatistics and Research Decision Sciences (BARDS) Organization have been asked to increase the speed and efficiency of their efforts while ensuring the highest standards of quality and accuracy.

The BARDS Organization uses SAS software for about 80 percent of the analyses they perform on data from every stage of development, including Phase I evaluations of compounds through post-marketing clinical trials, but they use other statistical packages for the remainder. Merck is seeking a solution that will allow them to analyze clinical trials data using several different kinds of software and execute other standardized data processing, such as baselining and safety tables -- all in a single, regulatory-compliant environment. Currently, the BARDS Organization is evaluating the ability of SAS Drug Development to provide the common analysis and reporting platform they need.

"We have a real need for technology that will support the process improvements we're making to achieve increased quality, reduced cycle times and improved efficiency," said Ray Bain, Ph.D., vice president in Merck's Biostatistics and Research Decision Sciences Organization. "The solution will be one common platform that can accomplish all these improvements in a compliant environment."

SAS Drug Development streamlines Solvay Pharmaceutical's global research operations
Solvay Pharmaceuticals uses SAS Drug Development to eliminate the geographic boundaries separating its data and to make the information available to anyone who needs it. This data is generated through internal sources and from outsourced clinical trials, and it all must be stored in a way that complies with stringent regulations placed on electronic data systems by the U.S. Food and Drug Administration (FDA).

To meet these challenges, Solvay Pharmaceuticals uses SAS Drug Development as the platform for providing global, secure access to the clinical information used by about 100 researchers worldwide working in a variety of areas, including data management, statistics, and clinical and medical review.

"Whether we're doing development in Asia, Europe or in the U.S., we need to be able to combine and share data -- and learn from it -- so that we can submit it for regulatory approval," said Rick Miller, director of clinical information management for Solvay Pharmaceuticals Inc. "SAS Drug Development gives us the ability to be a truly global organization."

SAS Drug Development rides the SAS9 wave
Engineered on the SAS9 Intelligence Platform, SAS Drug Development 3.0 allows users to access research and clinical trials data scattered in silos across different departments on incompatible systems, and then integrate the data quickly, seamlessly and in a cost-effective, regulatory-compliant manner.

Those firms already using SAS in their organizations -- including every FORTUNE Global 500 life sciences company and nearly 600 pharmaceutical companies and divisions worldwide -- can accelerate the clinical trials process with SAS Drug Development 3.0. The new version provides a true production environment for the mass generation of clinical trial analysis datasets and statistical summaries, as collections of SAS programs used by different research teams and operational departments can be easily managed within SAS Drug Development. Embedded versioning, audit trails, electronic signatures and related controls provide full, irrefutable documentation of any data transformation and analysis activities.

Wide acceptance in the life sciences
The life sciences industry has embraced SAS Drug Development as a leading standard in clinical trials information management, data integration and analysis. Nearly a dozen pharmaceutical firms worldwide including NeoPharm, Sankyo and Solvay have selected SAS Drug Development to deliver superior data warehousing, analytic, reporting and exploring technologies that help turn vast amounts of data into the kind of intelligence demanded by decision makers who need to respond quickly with the right decisions.

SAS has also enjoyed continued success in leveraging its extensive alliance network to promote the use of SAS Drug Development. SAS has established strong alliances with major consulting, information technology (IT) and outsourcing services firms including Accenture and IBM Healthcare and Life Sciences to help organizations incorporate SAS Drug Development into their existing IT infrastructures and business processes.

Leading EDC vendors, including DATATRAK and etrials Worldwide, have implemented SAS Drug Development to accelerate the shift away from paper-based processes for conducting and managing clinical trials to fully electronic clinical trials that extend traditional clinical data management systems (CDMS).

Also, cutting-edge CROs, including Constella Group, LLC, use SAS Drug Development to merge the day-to-day planning and execution of clinical trials with SAS' powerful data integration and analysis.

Today's announcement was delivered at the 30th annual SAS Users Group International (SUGI) conference. More than 3,000 SAS users from around the world attended this year's SUGI in Philadelphia.

About SAS
SAS is the market leader in providing a new generation of business intelligence software and services that create true enterprise intelligence. SAS solutions are used at more than 40,000 sites -- including 96 of the top 100 companies on the FORTUNE Global 500 -- to develop more profitable relationships with customers and suppliers; to enable better, more accurate and informed decisions; and to drive organizations forward. SAS is the only vendor that completely integrates leading data warehousing, analytics and traditional BI applications to create intelligence from massive amounts of data. For nearly three decades, SAS has been giving customers around the world The Power to Know.

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