Prescription for Going Paperless

Daiichi Sankyo Pharma Development uses SAS® to make faster decisions about drug development

As pharmaceutical companies jostle for an edge in an ever-competitive industry, those that come out on top are the ones that have streamlined their research and development efforts for decreased drug development costs, faster time to submission, faster time to market and, thus, improved earnings.

Daiichi Sankyo Pharma Development, a New Jersey-based company, designs and conducts global experimental clinical research, coordinates global pivotal clinical trial plans, and designs and executes pivotal clinical trials in the United States.

Using SAS Drug Development as the centerpiece of a suite of hosted clinical solutions, Daiichi Sankyo Pharma Development has innovated its clinical trials processes by outsourcing the systems infrastructure of its clinical trials, allowing staff to focus on core research functions.

"Our core competency is the development of new medications, not the creation and maintenance of a clinical data management system (CDMS)," says Dr. Ron Fitzmartin, Vice President of Informatics and Knowledge Management at Daiichi Sankyo Pharma Development. "This system, with SAS Drug Development at its core, will enable Daiichi to eliminate paper-based systems – and the inevitable errors that result from the use of these systems – and help us make quicker decisions about which compounds hold the most promise."

SAS, along with the other components in the suite of leading-edge clinical trials software solutions, will fulfill Daiichi's need to capture, access, manage and use clinical trials data by providing electronic data capture (EDC), data integration, medical event auto-encoding, data visualization, and data analysis and reporting capabilities. In addition to SAS, the suite includes these hosted solutions:

• DATATRAK Aware, powered by SAS, integrates DATATRAK's EDC solution with SAS Drug Development for rapid data capture and processing.
• dsNavigator, Galt Associates' market-leading coding management solution, combines functionality for searching, navigating, batch and interactive auto-encoding, and dictionary management into a single, customizable Web-based application.
• Integrated Clinical Systems' Integrated Review and JReview perform clinical data review, reporting, multidimensional analysis, graphics and statistical modeling.

Delivering foresight, understanding
SAS Drug Development leverages the breakthrough capabilities of the SAS®9 Intelligence Platform to remove obstacles in sharing data and applications across organizations, delivering foresight and understanding. 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 companies.

By integrating SAS with the suite's other components, Daiichi is able to bypass the traditional CDMS, which would require a massive capital investment in IT infrastructure and a dedicated staff to install, configure and maintain the system, Fitzmartin says. And a traditional CDMS is designed to support a process for paper-based clinical trials, which Fitzmartin considers a waste of time and money.

"Changes are underway that allow data managers to spend less time on resolving data discrepancies and more time collaborating with statisticians and clinicians to facilitate rapid access to the data needed for review and decision making," Fitzmartin says. "To succeed in this transformation, the industry is eliminating transactional, paper-based processes and moving toward flexible systems that streamline the process of capturing clinical trials data and pipelining the information into a SAS repository specifically designed for data review, analysis and reporting. The scalable data repository then can be leveraged to facilitate the warehousing and mining of integrated efficacy, safety and pharmacogenomic data."

21 CFR, CDISC compliant
SAS provided a solution that is compliant with Federal Drug Administration (FDA) regulations, such as 21 CFR Part 11, which is often difficult for companies to attain. And SAS allows Daiichi to comply with data standards such as CDISC (Clinical Data Integration Standards Consortium).

"With SAS, we're going to cut out the use of transactional paper processing and go 100 percent EDC right into the SAS Drug Development repository, and then the data will be CDISC-compliant and analysis-ready," Fitzmartin says. "What's innovative about SAS and the suite of hosted solutions is that they afford us the opportunity to have best-in-breed solutions and efficiently and effectively move clinical data from an operational state into a dynamic repository."

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