PAREXEL Enhances End-to-End Clinical Development Services
November 17 2015 - 9:00AM
Business Wire
New, dynamic technology-enabled processes offer
sponsors speed and simplicity in study design, start-up, execution,
and submission
PAREXEL International Corporation (NASDAQ: PRXL), a leading
global biopharmaceutical services provider, today announced the
enhancement of its end-to-end clinical development services through
its new process, called Clinical Development Optimization. The
PAREXEL® Clinical Development Optimization process uses advanced
technology to help expedite drug development through all four
critical stages of clinical development – design, start-up, trial
execution, and submission.
Two significant challenges in clinical trials today are patient
recruitment and protocol-related delays. Forty-eight percent of
sites miss enrollment targets, and study timelines are often
extended to almost double their original length to meet enrollment
levels.1 Additionally, on average, two to three protocol amendments
can delay a trial by two months, with each amendment adding
$500,000 in additional costs.2
“Challenges in clinical trials can translate into lost revenue
and significant delays in getting new, cutting edge medicines to
patients,” said Sy Pretorius, M.D., Chief Scientific Officer,
PAREXEL. “To help clients overcome these challenges, we applied our
advanced technology services and systems to the clinical
development process. The result is data we can leverage to improve
protocol design, patient recruitment, site selection and
feasibility, and analysis and reporting for our clients.”
PAREXEL Clinical Development Optimization increases the
efficiency of all stages of clinical development:
- Design: Protocol design
optimization using simulations enables sponsors to identify and
quantify the impact of trade-off decisions on program performance,
timelines and cost.
- Start-up: Site start-up,
Clinical Trial Management System (CTMS), and electronic Trial
Master File (eTMF) integrated applications provide efficient
distribution, collaborative compilation and e-signing of site-level
regulatory documents and contracts. Clinical Trial Supplies &
Logistics handles supply chain challenges and optimizes supply
levels.
- Execute: Intelligent technology
from the PAREXEL Informatics product line helps predict and capture
core operational and scientific data.
- Submit: Data aggregation aligned
with commercial decision-making strategy can help ensure the right
technology and operational support for an initial regulatory
application, identification of future opportunities, and product
lifecycle management.
“The role of information technology in clinical development
continues to grow. Clients now expect faster study start-up,
advanced site feasibility, accelerated patient enrollment,
real-time surveillance, risk-based monitoring, and better data
standardization,” said Xavier Flinois, President, PAREXEL
Informatics. “Ultimately, PAREXEL Clinical Development Optimization
gives our clients the tools to make technology-enabled and
data-driven business decisions, helping to reduce risk, increase
clinical trial efficiency, and speed time to market for our clients
and for patients.”
For more information about PAREXEL Clinical Development
Optimization, visit
PAREXEL.com/solutions/clinical-research/clinical-development-optimization/.
About PAREXEL InternationalPAREXEL International
Corporation is a leading global biopharmaceutical services
organization, providing a broad range of expertise-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. PAREXEL
Informatics provides advanced technology solutions, including
medical imaging, to facilitate the clinical development process.
Headquartered near Boston, Massachusetts, PAREXEL has offices in 80
locations in 51 countries around the world, and had approximately
18,620 employees in the first quarter. For more information about
PAREXEL International visit www.PAREXEL.com.
PAREXEL and PAREXEL Informatics 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. 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.
1 Tufts Center for the Study of Drug Development Impact Report,
January/February 2013.
2 Tufts International Journal of Environmental Research and
Public Health, May 12, 2014.
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version on businesswire.com: http://www.businesswire.com/news/home/20151117005282/en/
PAREXEL InternationalCristi Barnett, +1
781-434-4019Cristi.Barnett@PAREXEL.comorPAN CommunicationsMatthew
Briggs, +1 617-502-4300PAREXEL@pancomm.com
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