BOSTON, May 20, 2014 /PRNewswire/ -- PAREXEL
International (NASDAQ: PRXL), a leading global biopharmaceutical
services organization, today announced the launch of its Perceptive
MyTrials® Data-Driven Monitoring solution. Developed
by PAREXEL Informatics, it is a key component of the Perceptive
MyTrials eClinical platform, an integrated suite of applications
for managing clinical trials.
On-site monitoring is a critical aspect of trial management,
with the primary function of identifying and mitigating patient
safety or data quality risks at investigative sites. The U.S. Food
and Drug Administration (FDA) and other regulatory bodies have
issued guidance to assist sponsors in developing risk-based
monitoring strategies that enhance patient protection and improve
trial data quality through more effective study oversight. They
have encouraged greater use of centralized monitoring methods to
evaluate clinical trial conduct and progress.
PAREXEL's new data-driven monitoring solution provides an
innovative approach to centralized risk-based monitoring. The
technology captures, consolidates and organizes clinical
information in real-time from disparate sources. As a result, drug
developers can accurately identify study risks and rapidly
determine what type of intervention may be required. Monitoring
focused on specific risk offers the potential to enhance patient
safety, reduce costs and promote regulatory
compliance.
"Perceptive MyTrials Data-Driven Monitoring uses clinical data
to guide monitoring activities as an alternative to periodically
scheduled monitoring visits, which can be time-consuming, costly
and inefficient," said Xavier Flinois, President of PAREXEL
Informatics. "Greater insight into study data allows for a more
precise determination of when on-site monitoring visits need to
occur and what activities should be undertaken during those visits.
This can make clinical trial participation safer for patients while
offering cost efficiencies for sponsors."
"Our data-driven monitoring solution builds on PAREXEL's
long-standing track record of developing innovative technologies to
continuously improve clinical processes," said Mark A. Goldberg, M.D., President and Chief
Operating Officer, PAREXEL. "Perceptive MyTrials Data-Driven
Monitoring represents the latest example of our leadership in
bringing efficiencies to the drug development process."
About PAREXEL International
PAREXEL International Corporation is a leading global
biopharmaceutical services organization, providing a broad range of
knowledge-based contract research, consulting, medical
communications, and technology solutions and services to the
worldwide pharmaceutical, biotechnology and medical device
industries. Committed to providing solutions that expedite
time-to-market and peak-market penetration, PAREXEL has developed
significant expertise across the development and commercialization
continuum, from drug development and regulatory consulting to
clinical pharmacology, clinical trials management, medical
education and reimbursement. Perceptive Informatics, Inc., a
subsidiary of PAREXEL, provides advanced technology solutions,
including medical imaging, to facilitate the clinical development
process. Headquartered near Boston,
Massachusetts, PAREXEL operates in 75 locations in 50
countries around the world, and has approximately 15,335 employees.
For more information about PAREXEL International visit
www.PAREXEL.com.
PAREXEL, PAREXEL Informatics, Perceptive, Perceptive MyTrials,
and "Your Journey. Our Mission." are trademarks or registered
trademarks of PAREXEL International Corporation or its
affiliates.
This release contains "forward-looking" statements regarding
future results and events. For this purpose, any statements
contained herein that are not statements of historical fact may be
deemed forward-looking statements. Without limiting the foregoing,
the words "believes," "anticipates," "plans," "expects," "intends,"
"appears," "estimates," "projects," "will," "would," "could,"
"should," "targets," and similar expressions are also
intended to identify forward-looking statements. The
forward-looking statements in this release involve a number of
risks and uncertainties. The Company's actual future results may
differ significantly from the results discussed in the
forward-looking statements contained in this release. Important
factors that might cause such a difference include, but are not
limited to, risks associated with: actual operating performance;
actual expense savings and other operating improvements resulting
from recent and anticipated restructurings; the loss, modification,
or delay of contracts which would, among other things, adversely
impact the Company's recognition of revenue included in backlog;
the Company's dependence on certain industries and clients; the
Company's ability to win new business, manage growth and costs, and
attract and retain employees; the Company's ability to complete
additional acquisitions, and to integrate newly acquired businesses
including the recent acquisitions of LIQUENT, Inc. and HERON Group
Ltd., Inc., or enter into new lines of business; the impact on the
Company's business of government regulation of the drug,
medical device and biotechnology industry; consolidation within the
pharmaceutical industry and competition within the
biopharmaceutical services industry; the potential for significant
liability to clients and third parties; the potential adverse
impact of health care reform; and the effects of exchange rate
fluctuations and other international economic, political, and other
risks. Such factors and others are discussed more fully in the
section entitled "Risk Factors" of the Company's Quarterly Report
on Form 10-Q for the quarter ended March 31,
2014 as filed with the Securities and Exchange Commission
(SEC) on May 2, 2014, which "Risk
Factors" discussion is incorporated by reference in this press
release. The Company specifically disclaims any obligation to
update these forward-looking statements in the future. These
forward-looking statements should not be relied upon as
representing the Company's estimates or views as of any date
subsequent to the date of this press release.
Contacts:
Diana Martin, Vice President,
Corporate Communications
PAREXEL International
Tel: +1 781-434-5516
Email: Diana.Martin@PAREXEL.com
Matthew Briggs
PAN Communications
Tel: +1 617-502-4300
Email: PAREXEL@pancomm.com
SOURCE PAREXEL International Corporation