FRENCHTOWN, NJ - Mar 3, 2014 - Integrated Clinical
Systems, Inc. launches JReview 10.0 - introducing Analytics for
Risk-based Monitoring
Frenchtown, NJ - March 1, 2014
Integrated Clinical Systems, Inc. (ICS) www.i-review.com, developers of
Integrated Review™ & JReview®, the world's most comprehensive
clinical review and analysis software tool, today announced the
launch of JReview version 10.0.
JReview version 10.0 introduces direct Analytics support for
Risk Based Monitoring (RBM), enabling centralized monitoring teams
to define key risk categories and indicators from clinical &
operational source data available, set thresholds, and specify
suggested actions in a newly introduced RBM module. The new
RBM Data Browser provides an overview of the generated risk-based
monitoring information - from the regularly scheduled batch
jobs. Also, a newly developed native iPad app provides easy
access to key RBM metrics and recommended actions for CRAs and
monitors in the field.
"We are really excited to offer RBM capabilities to our
customers with this release" says Eric S. Herbel, President of
ICS. "RBM has become a critical industry trend since the US
FDA & EMA have released their guidance on risk-based approaches
to clinical monitoring recently. Also, many of our customers are
members of the cross-industry consortium Transcelerate
Biopharma Inc. that has developed a methodology1 suggesting to
shift monitoring processes from an excessive concentration on
Source Data Verification to comprehensive risk-driven
monitoring." Risk indicators can involve any data accessible
by JReview - including the actual study data, but also other
important trial metrics, such as queries, entry rates, etc., which
would typically be accessed from EDC systems or CTMS databases.
JReview 10.0 also introduces Trellis plots - 'grid' displays,
such as the timeline trellis by patient, which is particularly
useful when reviewing lab data. Direct import of MS Excel™
spreadsheets is now supported, including the option to store the
spreadsheet contents in a common table in the database's
ReviewAdmin account or separate SAS datasets. A new multi-level
study hierarchy and multi-study mode across projects facilitates
the selection and pooling of multiple studies.
About JReview®
JReview® is the fastest, easiest way to review, graph, report,
and analyze your clinical data. It is a web-enabled software
application written specifically for pharmaceutical, biotech and
medical device companies doing clinical research. It provides many
vital tools needed to perform clinical data review, ad hoc
reporting, data visualization, analysis, and risk assessment of
clinical studies data. By interacting with various patient subsets
and using any combination of browser modules or dashboards within
the product, users can easily review and/or monitor their clinical
trials for safety, efficacy, etc.
About Integrated Clinical Systems, Inc.
Integrated Clinical Systems, Inc. (ICS) http://www.i-review.com,
headquartered in Frenchtown, NJ, is an industry-leading developer
of software applications for pharmaceutical, biotech and medical
device companies worldwide. Their original software application,
Integrated Review™, provides ongoing, real-time review of clinical
data and an easy-to-use, intuitive means of profiling patients,
reporting, graphing, ad-hoc data mining and signal detection for
clinical data stored in third-party or in-house data management
software systems or data warehouses. This functionality has been
ported to a web-enabled software application, JReview®, and has
been expanded even more with new features. These products have been
developed by professionals from the pharmaceutical industry, and
they continue to be refined and enhanced by customer and FDA
feedback. It is this specialization and industry focus that
provides their clients with the reporting and analysis capabilities
that allow them to bring products to the market safely,
efficiently, speedily and cost effectively.
Integrated Review™ is trademarked and JReview® is a
registered trademark of Integrated Clinical Systems, Inc. Copyright
© 2014. All rights reserved.
1Transcelerate Biopharma Inc.;Position Paper: Risk-Based Monitoring Methodology
For Further Information
US:
Europe:
Eric S. Herbel, President
Dr. Mark Demesmaeker
Integrated Clinical Systems,
Inc.
Integrated Clinical Systems, Inc.
900 State Hwy
12
Chemin de Mornex 2
Frenchtown, NJ
08825
1001 Lausanne
908-996-3312
Switzerland
eherbel@i-review.com
+41 (22) 518 2038
mdemesmaeker@i-review.com
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