Technology and data services to accelerate your drug development process

PAREXEL® INFORMATICS

From complexity to clarity, industry-leading, integrated platforms and applications

YOUR JOURNEY.OUR MISSION.™

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.

PAREXEL Informatics’ technologies 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.

“ 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

EXPERT eCLINICAL TECHNOLOGY SERVICESPERCEPTIVE 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.

Perceptive MyTrials 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

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’s ePRO (electronic Patient-Reported Outcomes) technologies help you choose the most effective electronic patient-reported outcomes solution for your trial. Patient- reported 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.

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, regu-latory 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.

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.

Our regional leads are always available for a conversation.

THE AMERICASDave Sunderhaft Vice President, eClinical Solutions Business Development +1 978 313 1892 dave.sunderhaft@PAREXEL.com

EUROPE Nathan Waller Senior Director, Business Development +34 91 516 5663 nathan.waller@PAREXEL.com

ASIA PACIFIC Toyohito Matsuura Senior Manager +81 78 262 4344 toyohito.matsuura@PAREXEL.com

MEDICAL IMAGING THE RIGHT INFORMATION AT THE RIGHT TIME

PAREXEL Informatics is a global leader in deploying time- and 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 recon- ciliation and export, final archival, regulatory support, and submission.

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 manage-ment. An open enterprise platform, LIQUENT centralizes your regulatory information to promote standardization,

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.

WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY.

©2014 PAREXEL International Corporation. All rights reserved.

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