PAREXEL Launches IDMP-Focused Software and Service Solution
November 14 2016 - 9:00AM
Business Wire
Solution developed to help biopharmaceutical
companies meet emerging regulatory requirements ahead of
deadline
PAREXEL International Corporation (NASDAQ: PRXL), a leading
global biopharmaceutical services provider, today launched an
Identification of Medicinal Products (IDMP)-focused solution for
biopharmaceutical companies. LIQUENT InSight® for IDMP™ is the
newest module added to PAREXEL’s Regulatory Information Management
(RIM) platform.
Beginning in 2018, the European Medicines Agency (EMA) will
require biopharmaceutical companies to submit data on medicines in
accordance with the International Organization for Standardization
(ISO) IDMP standards. Other major global market regulatory agencies
are expected to follow suit. The standards are designed to increase
transparency into authorized and investigational medicinal products
to improve patient safety.
PAREXEL’s LIQUENT InSight® for IDMP allows biopharmaceutical
companies to collect their data in a comprehensive and holistic
manner. It is fully compliant with the five ISO IDMP standards
defining product and registration data and details for
investigational and registered medicinal products. In addition,
PAREXEL Consulting’s subject matter experts work with clients to
develop a comprehensive IDMP strategy that ensures globally
standardized data.
“As biopharmaceutical companies establish their IDMP programs,
they will require capabilities to help them meet global standards
and eliminate complexity,” said Paul Bidez, Ph.D., Vice President,
Regulatory Solutions, PAREXEL. “Our solution combines deep subject
matter expertise, specialized master data management, integration
services, and purpose-built technology. With this new offering,
PAREXEL clients gain a well-structured IDMP program with the
potential to ensure compliance, provide greater efficiency, reduce
costs, and simplify processes.”
PAREXEL’s end-to-end IDMP solution is available around the
world, directly from PAREXEL or through the PAREXEL Partner
Program. The solution can be deployed on-premises or in PAREXEL’s
Regulatory Cloud, a life sciences content and regulatory
information management solution structured within a dedicated,
private cloud environment. For more details, visit:
https://www.parexel.com/solutions/consulting/idmp-solutions.
About PAREXEL InternationalPAREXEL International
Corporation is a leading global biopharmaceutical services company,
providing a broad range of expertise-based clinical 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, and
reimbursement. PAREXEL Informatics provides advanced technology
solutions, including medical imaging, to facilitate the clinical
development process. Headquartered near Boston, Massachusetts,
PAREXEL has offices in 85 locations in 51 countries around the
world, and had approximately 18,750 employees in the first quarter.
For more information about PAREXEL International visit www.PAREXEL.com.
PAREXEL, LIQUENT Insight, and LIQUENT Insight for IDMP are
trademarks or registered trademarks of PAREXEL International
Corporation or its affiliates. All other trademarks are the
property of their respective owners.
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. Such
factors and others are discussed in the section entitled “Risk
Factors” of the Company’s most recent Annual Report on Form 10-K
and subsequent quarterly reports on Form 10-Q filed with the
Securities and Exchange Commission, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161114005032/en/
Cristi Barnett, PAREXEL InternationalTel.: +1 781-434-4019Email:
Cristi.Barnett@PAREXEL.comorJenny Radloff, PAN CommunicationsTel:
+1 617-502-4300Email: PAREXEL@pancomm.com
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