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
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.