Download Technology and data services to accelerate your drug

PAREXEL
INFORMATICS
®
Technology and data services to accelerate your
drug development process
YOUR JOURNEY.
OUR MISSION.
™
From complexity to clarity, industry-leading, integrated
platforms and applications
“INCREASED COMPLEXITY IN THE GLOBAL LIFE
SCIENCE ECOSYSTEM, GROWING REGULATORY
REQUIREMENTS, AND INTERNAL INITIATIVES
TO RAPIDLY IMPROVE ORGANIZATIONAL
EFFICIENCY ARE DRIVING LEADING LIFE
SCIENCE COMPANIES TO FINALLY ABANDON
THEIR INDIVIDUAL LEGACY APPLICATIONS AND
UPGRADE TO INTEGRATED, BEST-OF-BREED
VENDOR SOLUTIONS TODAY.”
ALAN S. LOUIE, PH.D.
RESEARCH DIRECTOR, CLINICAL DEVELOPMENT,
STRATEGY AND TECHNOLOGY, IDC HEALTH INSIGHTS
PAREXEL® Informatics develops the technological innovations to
make the process of drug development faster, more accurate,
more productive and easier to track.
Our dedicated Informatics group creates industry-leading,
integrated platforms and applications designed by clinical
researchers to improve the way companies perform clinical
trials, control and share data, track and report patient outcomes,
and manage regulatory information.
Paired with PAREXEL’s 30+ years of in-depth clinical, regulatory,
and commercialization expertise, our technology solutions
leverage proven best practices to simplify the drug development
process from beginning to end.
The technologies delivered by PAREXEL Informatics will help
you maximize the value of your product portfolio, assure
the integrity of your data through the pipeline, and accelerate
the progress of your journey.
EXPERT
eCLINICAL
TECHNOLOGY
SERVICES
PERCEPTIVE MYTRIALS®—SINGLE-POINT
ACCESS TO CLINICAL DATA AND APPLICATIONS
Perceptive MyTrials® is a versatile and comprehensive
software-as-a-service (SaaS) platform that gives
you single-point access to a suite of fully integrated
applications, data, and information associated with
clinical trials and programs. The Perceptive MyTrials
platform provides unified access to an eClinical
suite of tools, each a proven leader in its own right,
that can be used in combination or as stand-alone
solutions to the key problems faced by clinical
researchers today.
The Perceptive MyTrials platform simplifies the drug
development journey by providing a central point of
management for:
• Electronic data capture, randomization, and trial
supply management
• Regulatory information management
• Clinical trial management
• Medical imaging
• Electronic patient-reported outcomes
As an open platform, Perceptive MyTrials not only
integrates seamlessly with other PAREXEL
technologies, but also with third-party tools you
may already be using.
100
%
OF THE TOP 15
PHARMA COMPANIES
are running PAREXEL® technology
END-TO-END TECHNOLOGY
FOR EVERY PHASE
DATALABS® EDC
STREAMLINE DATA COLLECTION,
USE AND REPORTING
PAREXEL’s DataLabs® EDC is an Electronic Data Capture
system designed to ease workflows and simplify the entire
clinical trial process. The DataLabs EDC system not only
collects and unifies clinical data from disparate paper and
electronic sources (including third-party applications), but
also helps you share and use the data with complementary
applications, and provides reports to support clinical,
regulatory and marketing activities.
IMPACT® CTMS
SMARTER TRIALS MANAGEMENT
AND MONITORING
IMPACT® CTMS is a leading clinical trials management
system designed to help you manage the complexities of
your trials more effectively. The IMPACT CTMS system
provides fast, flexible global integration, an adaptive
framework and exceptional functionality. Its product
modules deliver comprehensive management of trial
planning, country and site progress, monitoring activities,
supplies and finance, with state-of-the-art investigator
data mining and operational support.
IMPACT® EXPRESS
An ideal solution for customers seeking a lightweight
CTMS that can be deployed quickly. IMPACT Express
delivers exceptional functionality at the right price. Its’
simple, out-of-the-box deployment eliminates the need for
technical infrastructure or resources. And since it includes
comprehensive training, your users will be running the
system confidently from trial startup to trial completion.
Specific processes addressed within IMPACT Express
include: trial oversight; trial tracking and management; site
monitoring; investigator management and selection; as
well as payment management.
DATA-DRIVEN MONITORING
Perceptive MyTrials® Data-Driven Monitoring shifts the
burden of site monitoring from a people-centric approach
to a model that leverages the power of technology to
measure and assess both risk and outstanding workload.
Data-Driven Monitoring assists in the prioritization of trial
monitoring, and provides tools to seamlessly plan and
schedule related activities.
CLINPHONE® RTSM
IMPROVE RANDOMIZATION AND
SUPPLY MANAGEMENT
Our ClinPhone® RTSM (Randomization and Trial Supply
Management) system is the industry’s most trusted IVR/
IWR system, to manage randomization and medication
dispensing and inventories. The ClinPhone RTSM system
helps you easily perform a comprehensive range of
supplies administration and site management activities.
With ClinPhone RTSM, you can also monitor real-time
recruitment, manage emergency treatment code breaking,
help ensure accurate dosing and manage early phase
cohort studies.
PAREXEL® ePRO SOLUTION
MORE THAN 2M ASSESSMENTS
DELIVERED WORLDWIDE
PAREXEL® ePRO (electronic Patient-Reported Outcomes)
technologies help you choose the most effective electronic
patient-reported outcomes solution for your trial. Patientreported outcomes are playing a growing role in assessing
efficacy and quality of life, recruiting patients, measuring
symptoms, providing safety information, and monitoring
medical compliance. ePRO can simplify and facilitate using
those patient reports more rapidly, accurately and for less
cost. PAREXEL makes it easy for you to decide which ePRO
method is optimal for your protocol, whether Interactive
Voice Response (IVR), Interactive Web Response (IWR),
PDA or Tablet.
MEDICAL IMAGING
THE RIGHT INFORMATION AT THE RIGHT TIME
PAREXEL® Informatics is a global leader in deploying timeand budget-saving medical imaging tools in clinical trials
across the entire project life cycle. Medical imaging can
serve as a surrogate endpoint, letting you “see” the effect
of a new drug much earlier than traditional endpoints,
and can also offer effective support for “go/no-go” pipeline
decisions. PAREXEL’s full range of services comprises
all the necessary pieces for successful trial imaging
implementation, including protocol/study design and
charter development, site qualification, in-house image
QC, independent image reading and analysis, data reconciliation and export, final archival, regulatory support,
and submission.
improve collaboration, ensure compliance, eliminate waste,
reduce costs, accelerate product releases, and allow you
to operate and compete more effectively everywhere.
PERCEPTIVE MYTRIALS®
CUSTOMER CARE SERVICES
TECHNICAL SUPPORT AND GLOBAL
HELP DESK SERVICES 24/7/365
The Perceptive MyTrials® Customer Care Services (CCS)
group provides single point of contact technical support
and global help desk services for all PAREXEL applications
and a one-stop shop for all your clinical trial support
needs including other clinical trial technologies, technology
integrations, medical escalations, emergency unblinding
and direct patient support.
LIQUENT® INSIGHT
WORLD’S LEADING REGULATORY
INFORMATION MANAGEMENT PLATFORM
LIQUENT® Insight is the only fully integrated, end-to-end
Regulatory Information Management (RIM) solution
available today. LIQUENT Insight accelerates the journey
of your product by delivering powerful submission
planning, publishing, viewing, and registration management. An open enterprise platform, LIQUENT centralizes
your regulatory information to promote standardization,
Our regional leads are always available
for a conversation.
THE AMERICAS
Ricardo Edwards
Senior Director, Business Development
+1 908 232 1024
[email protected]
EUROPE & ASIA PACIFIC
David Rolfe
Vice President, Business Development
+44 1 895 61 4808
[email protected]
WHEREVER YOUR
JOURNEY TAKES YOU,
WE’RE CLOSE BY.
CORPORATE HEADQUARTERS
195 West Street
Waltham, MA 02451
USA
+1 781 487 9900
Offices across Europe, Asia and the Americas
www.PAREXEL.com
©2015 PAREXEL International Corporation. All rights reserved.