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New JMP® Clinical software streamlines clinical trials safety reviews

Customized application from SAS eases migration to global data standards

WASHINGTON, DC  (Jun. 14, 2010)  –  JMP Clinical software, new from SAS, can help shorten the drug development process by streamlining safety reviews during clinical trials. SAS, the leader in business analytics software and services, introduced JMP Clinical today at the annual meeting of the Drug Information Association (DIA).

Dynamically linking advanced statistics and graphics, JMP Clinical lets users see and explore safety data from every angle, and then easily share findings with others. It enables sophisticated analysis of adverse events, labs, incidence indicators and patient profiles by combining powerful SAS® Analytics with the interactive data visualization capabilities of JMP.

“It was clear to us early on that JMP Clinical could help us more rapidly advance projects and analyses critical to the drug approval process,” said Steve Wong of Gilead Sciences Inc., Senior Director for Statistical Programming in the company’s Biometrics Department and a beta tester for JMP Clinical. “JMP has developed a tool that takes into account and addresses many of the complexities of data analysis, adding significant value to our work.”

Building on a trusted heritage

This customized software combines two of the most trusted names in life sciences analytics. JMP is the tool of choice for more than 40 percent of medical reviewers at the Food and Drug Administration (FDA). SAS is the analysis and reporting standard for biostatisticians in the pharma industry.

JMP Clinical simplifies communications – first internally among medical reviewers, epidemiologists, data monitors, biostatisticians and biometrics groups engaged in analyzing safety data from clinical trials, and later between sponsor organizations and FDA reviewers. Customized dialogs put flexible analysis options in the hands of users, regardless of their statistical savvy.

Easing the migration to global CDISC standard

A menu-driven desktop system in JMP Clinical follows FDA reporting guidelines in logical sequence. The software works behind the scenes to automate the analytics and reporting from standard Clinical Data Interchange Standards Consortium (CDISC) data, the emerging global standard for clinical analysis and reporting.  As one of the first tools to inherently understand data from the CDISC Analysis Data Model (ADaM), JMP Clinical helps clinicians and biostatisticians migrate into the modern review environment.

With JMP Clinical, reviewers spend more time exploring patterns and predicting outcomes in clinical trials data – and less time programming or manipulating data tables. Its intuitive dashboard assures simplified drug safety analysis backed by statistically rigorous screening of all safety domains. JMP Clinical reduces false-discovery rates, mitigating the risk of over-reporting adverse events.

Offering easy access to the data behind the graphics, JMP Clinical permits clustering of events, interventions and findings.

For more information, stop by Booth 1601 this week at DIA or go to http://www.jmp.com/clinical.

About SAS

SAS is the leader in business analytics software and services, and the largest independent vendor in the business intelligence market. Through innovative solutions delivered within an integrated framework, SAS helps customers at more than 45,000 sites improve performance and deliver value by making better decisions faster. Since 1976 SAS has been giving customers around the world The Power to Know® .

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