SAS Drug Development: The Intelligence to Efficiently Manage Clinical Research Data

In particular, 'blockbuster' drugs are increasingly hard to find and costly to develop, while drugs that have been approved can be withdrawn based on safety concerns. It's hardly surprising that with tighter competition and a falling stock market, many pharmaceutical companies are now feeling the pressure. In this situation, companies need a flexible and dynamic solution to underpin successful drug development.

"That may sound simple but most software fails to tick all the boxes," says Crawford. "A comprehensive solution has to manage clinical research data efficiently and it must provide fast answers to questions about safety and efficacy. Most critical of all is that the solution should be fully compliant with the regulatory environment."

Pharmaceutical Intelligence
SAS Drug Development provides the intelligence organisations need to manage research data effectively within a strong collaborative framework. Secure access means people can work with the solution anywhere using a standard web browser, while a clinical data explorer enables you to view and analyse patient data easily. "In this way, you get the all-important answers you need in areas like safety and efficacy," says Crawford.

Collaborative working is especially important now that development projects typically involve teams from different organisations; SAS enables real-time collaboration between sponsors, CROs, data review boards and regulators. Meanwhile, with interim data reviews provided quickly and easily, companies have the optimum environment for maintaining a comprehensive view of a compound's progress.

The drug development process is cyclical in nature - encompassing integration, analysis, discovery, and then re-integration of this newly discovered information back into the pool of knowledge of the clinical research program.

Fully Regulatory Compliance
Projects can, of course, take years to complete. While the clinical research program evolves, so does the organisation - staff move to other projects and companies can merge - while volumes of data and information continue to grow. So effective knowledge management is vital. SAS manages all the information related to a research program in a central location. "A centralised repository saves time and helps control costs by removing the need to trace reports, find data or identify individuals," says Crawford. "Managers and staff can present biomedical information in a standard format on which the research organisation and regulatory authorities can agree." SAS provides consistent, integrated support for regulatory compliance throughout the entire drug development process, including 21 CFR Part 11.

And of course because it is SAS software, you can leverage all your existing data and systems: the organisation can rapidly transform and integrate raw data from any source or platform into usable intelligence, all within a regulatory compliant framework.

Companies also have the option to offload the IT overhead altogether by using SAS Drug Development as an Application Service Provider (ASP) solution. "As well as behind-the-firewall installations, we offer the flexibility, ease of access and cost transparency of the ASP model, provided through a secure link to a protected facility," adds Crawford.

For further information on SAS Drug Development, please visit: http://www.sas.com/industry/pharma/develop/

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