PAREXEL Expands Managed Access Programs Service Offering
27 January 2017 - 1:00AM
Business Wire
Simplified, end-to-end solution will help
biopharmaceutical clients provide compassionate access to their
treatments for patients
PAREXEL International Corporation (NASDAQ: PRXL), a leading
global biopharmaceutical services provider, today launched an
expanded Managed Access Programs service. PAREXEL now offers
end-to-end expertise for the design, development, and delivery of
managed access programs to help biopharmaceutical companies provide
access to investigational medical products for patients in
need.
Managed Access Programs provide use of an investigational
medical product by a patient when enrollment in a clinical trial is
not possible. Often called “Compassionate Use” or “Expanded
Access,” these programs allow patients to obtain direct and rapid
access to a therapy while regulatory or reimbursement processes are
still ongoing. A treating physician or patient may request such
access in the absence of comparable or satisfactory alternative
therapy or when the investigational product presents less risk than
the disease or condition for the patient.
“Managed Access Programs can be complex to operationalize. They
require expertise and experience in managing these types of
programs as well as a global network to deliver these solutions
with key agencies, regulators, local decision makers, and the
medical community,” said Peggy Schrammel, Vice President, Managed
Access Programs, PAREXEL. “PAREXEL’s unique configuration of
simplified, end-to-end services for Managed Access Programs
includes seasoned operational teams, global regulatory expertise,
proprietary technology, and global clinical logistics.”
In addition to designing all aspects of the program, PAREXEL
clinical logistics experts manage the supply of the medicinal
product, ensuring on-time delivery and ongoing availability of
product for each enrolled patient on a worldwide basis. Leading
global safety experts oversee all aspects of pharmacovigilance and
reporting requirements of safety events, while market access
experts help clients determine the utility of collected data for
commercial and medical stakeholders as indications of real world
value.
PAREXEL’s expanded Managed Access Programs service is available
around the world as part of the MyAccessProgramsTM platform, a
proprietary technology of PAREXEL. The platform can support
multiple Managed Access Programs for a client, including patient
identification, physician enrollment, stakeholder communications
management, and drug supply management. MyAccessProgramsTM platform
also provides clients with real-time progress oversight.
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 and MyAccessPrograms 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/20170126005060/en/
Media:Cristi BarnettTel.: +1 781-434-4019Email:
Cristi.Barnett@PAREXEL.comorJenny Radloff, PAN CommunicationsTel:
+1 617-502-4300Email: PAREXEL@pancomm.comorInvestors:Ronald
AldridgeTel.: +1-781-434-4753Email: ron.aldridge@PAREXEL.com
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