Bringing new therapies to market requires a process that is extraordinarily complex. Clinical trials data is scattered among different systems throughout life sciences research organizations, and new data arrives almost continuously from electronic data capture (EDC) vendors, contract research organizations (CROs) and other research partners.

Meanwhile, costs are escalating, budgets continue to shrink, and the pressure from regulatory agencies, shareholders and consumers has never been greater. It's imperative that life sciences executives make informed decisions quickly and efficiently. But they can do so only if they have the utmost confidence in their clinical, data management and biostatistical information and processes.

SAS Drug Development 3.0, software that leverages the breakthrough capabilities of the SAS Intelligence Platform removes the obstacles to sharing data and applications across organizations and delivers 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. They also can 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, accepted 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," says 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."

Wide acceptance
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. SAS helps turn vast amounts of data into the kind of intelligence demanded by decision makers who need to respond quickly with the right decisions. Merck & Co. is currently evaluating SAS Drug Development for improved analysis and reporting.

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 data sets and statistical summaries, as collections of SAS programs used by different research teams and operational departments can be managed easily within SAS Drug Development. Embedded versioning, audit trails, electronic signatures and related controls provide full, irrefutable documentation of any data transformation and analysis activities.