JMP Clinical software streamlines clinical trials safety reviews

30 June 2010

JMP Clinical software, new from SAS, can help shorten the drug development process by streamlining safety reviews during clinical trials.

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 visualisation capabilities of JMP.

“It was clear to us early on that JMP Clinical could help us more rapidly advance projects and analysis 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.”

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

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.