1 THE CONNECTED JOURNEYTM

Image: School of fish

THE CONNECTED JOURNEY TM

OF DATA-DRIVEN SERVICES

2 3THE CONNECTED JOURNEYTM THE CONNECTED JOURNEYTM

A NEW DAY. A NEW WAY FORWARD.

DERIVING VALUE FROM THE DATA.

JOSHUA SCHULTZ Senior Vice President, Worldwide

Head of PAREXEL Access

THE DATA DOESN’T JUST NATURALLY GIVE YOU THE

ANSWER. THERE’S A GENUINE NEED FOR SOPHISTICATED

ANALYTICS AND OUR SPECIALIZED EXPERTISE.

1. Source: Outlook 2015, Tufts Center for the Study of Drug Development.2. Source: KMR Group – Clinical Group, 2015

THE CONNECTED JOURNEYTM IS HELPING COMPLETE TRIALS 22% FASTER THAN THE INDUSTRY AVERAGE.22%

Today, no two drug development journeys are the same. Generics, biosimilars and specialty drugs are all on the rise. And regulators are encouraging sponsors to explore novel development pathways.1 As the industry moves toward precision medicine, studies become increasingly complex, therapeutic areas become increasingly nuanced, global regulatory challenges evolve more rapidly, and overcoming reimbursement hurdles becomes the challenge of the day. Sponsors are facing extreme pressure to deliver quality results in a timelier fashion. And for too many patients, these treatments can’t come soon enough.

We are at a crossroads—our sponsors cannot afford to settle for slight improvements here and there that help

The greatest opportunity to advance drug development lies in data. But data means nothing if it can’t be used to derive insights that inform timely, actionable decisions throughout the drug development journey.

In every phase, the task is the same—identify the type of data you want to collect, then set up the infrastructure to bring that data in. For biopharmaceutical customers, collecting too much data can be expensive and overwhelming. Collecting too little may negatively impact their ability to demonstrate value.

At PAREXEL, the Connected JourneyTM enables us to work cohesively to strike the right balance of data to yield key insights and decision-making. This includes the integration of real-world evidence that can make studies more efficient. Aggregating the right data and then leveraging it to drive value requires the best people, processes and technologies working together. And it is our capabilities in these areas that set us apart.

them keep pace. They need to achieve significant gains in every area so they can lead. In order to stay ahead in today’s environment, what’s needed is a new approach. One that brings our vast and exceptional resources together in innovative ways—that leverages data to drive value—by turning information into insights that inform every key decision.

At PAREXEL we have led the industry on an innovative path forward for over 35 years. Now we are paving a new way, with a new ecosystem that’s been purposefully designed to help us meet today’s challenges as well as tomorrow’s. Together. We call it the Connected JourneyTM. It is already helping us complete clinical trials 22% faster than the industry average.2 And it is only the beginning…

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The resources we need exist, but to work most effectively they must all be brought together. To move from a piecemeal series of disconnected processes and technologies to a more connected and collaborative approach. That’s what PAREXEL’s Connected JourneyTM does. Others may say their networks offer all of the solutions and expertise you’ll need, but only PAREXEL truly integrates them.

PAREXEL’s Connected JourneyTM is a first-of-its-kind, purpose-built ecosystem engineered to transform the drug development lifecycle —moving from single solutions to the industry’s largest footprint of connected and collaborative data-driven innovations. In this ecosystem, data, technology, processes and expertise are all seamlessly connected.

“ When we say the Connected JourneyTM, we’re also talking about the way we collaborate with our customers,” says Sean Gallimore, Corporate Vice President and Chief Marketing Officer at PAREXEL. “Some of our best work happens when we co-solve for the challenges they face.”

By connecting everything, and everyone, we can more confidently identify, analyze, integrate, exchange and apply data-driven insights at every stage, and get to the answers we need that much faster.

MORE THAN A NETWORK, AN ECOSYSTEM.

THE AMOUNT PAREXEL ANALYTICS HAS HELPED REDUCE AD HOC MANUAL REPORT GENERATION, WHILE ENABLING INCREASED LEVELS OF ACCURACY AND NEAR REAL-TIME ACCESS.

XAVIER FLINOIS President,

PAREXEL® Informatics

CONNECTING DATA, TECHNOLOGY, PROCESSES AND EXPERTISE

PAREXEL’S CONNECTED JOURNEYTM PROVIDES:

THE CONNECTED JOURNEYTM is powered by PAREXEL® Analytics, a multi-dimensional business intelligence layer that aggregates internal and open-source data in real time to simplify data analytics and insights for smarter decisions at every step of the drug development journey – design, start-up, execution, submission and commercialization.

PAREXEL® Analytics is constructed with purpose—so that data can be

POWERED BY PAREXEL® ANALYTICS.

Efficient clinical study delivery and regulatory guidance that enhances portfolio value and commercialization opportunities

Integrated data platforms throughout the drug development lifecycle

Flexible and transparent outsourcing models that demonstrate key performance indicators to customers

Efficiency and speed from advanced analytics that enable site start-up, patient recruitment, country milestone management, and submission

Visualization of data-driven insights that are easily accessible, readable and able to inform drug development decisions

accessed, analyzed and visualized in real time. Using a suite of dashboards designed to leverage the power of predictive analytics presented in new and compelling ways, PAREXEL’s clinical, regulatory and commercial teams can leverage and apply data-driven insights to client portfolios. The system architecture can access countless data sources, including various types of real-world data, to extract actionable insights. Ultimately, this helps to expedite clinical development and commercialization progress.

90%

BECAUSE WE’RE USED TO BEING ON THE FRONT LINE OF

INNOVATION, IT’S EASIER FOR US TO INCORPORATE NEW TOOLS

INTO OUR WORKFLOWS, WHICH INCREASES THE SPEED OF

DRUG DEVELOPMENT.

THE BEST WAY TO LEVERAGE THE BENEFITS

OF THE ASSETS IS BY ENABLING THE ENTIRE TEAM

TO WORK TOGETHER MORE EFFICIENTLY. THE REAL VALUE

COMES FROM OUR ABILITY TO INNOVATE THE ENTIRE

CONTINUUM FROM DEVELOPMENT TO MARKET ACCESS.

CHRISTIAN DREGERSenior Vice President,

PCMS & Access

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– Teams can think about design holistically.

– A convergent digital platform visualizes data to inform a variety of discussions.

– An intelligent blend of analytics and external data helps teams select the right countries, sites and patients to address regulatory and commercial goals.

– Protocol Optimization experts use predictive modeling to provide sponsors with study design options that address their priorities.

– Quantitative Clinical Development experts analyze early phase trial data to design studies that get to the right dose sooner.

– A powerful Site Intelligence Management System enables teams to take a multi-faceted look at risk.

– Historical and feasibility data for sites are turned into active knowledge that guides our site assessments.

– Advanced analytics helps teams more accurately forecast and manage mission- critical milestones from the beginning of a study.

– Plans and bids align to everyone’s expectations.

– Teams can focus on collecting the right data for their needs.

– Commercialization consultants are invited to review early phase data as it emerges and help shape the direction of subsequent trials.

– Evidence generation and value demonstration support pricing and reimbursement negotiation for market access.

– Strong relationships with over 200 data providers enable us to leverage real-world data to support market access.

The Connected JourneyTM creates a myriad of op-portunities to inform de-cisions with data-driven insights.

1 DESIGN

IN OUR CONNECTED ECOSYSTEM...

IMPACT

5 COMMERCIALIZE2 START-UP

12% faster time from final protocol available to last site initiated than the industry average.1

– Data is standardized and quickly normalized in order to give teams remarkable visibility into the status of trials.

– Everyone who needs to know the status of patient enrollment, does.

– Teams can monitor a study’s operational and scientific (clinical) master data from afar and address site behaviors in a more targeted way, so they can neutralize risks to a study’s data integrity at lower cost.

– Superior metadata makes haystacks of information not only more usable, but reusable.

3 EXECUTE

4% shorter cycle times – up to 4 months faster – from final protocol available to database lock than industry average.5

Up to 20% efficiency generated in developing evidence platforms for compounds while identifying new value opportunities.7

– Genomics information is available to answer regulator questions, even before they ask.

– A single solution bridges the needs of medical affairs and market access groups.

– Data-driven insights inform submission planning, publishing, viewing, and registration, as well as lifecycle management.

– These insights help us not only get new drugs to market, but keep them there.

4 SUBMIT

39% faster turnaround times from database lock to clinical study report approved than industry average.6

CONNECTED AT EVERY STAGE.

21% faster start-up than industry competitors.4

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

UNITED STATES

Frederick LeMoine Corporate Vice President, Business Development +1 919 294 5125 frederick.lemoine@PAREXEL.com

EUROPE

Annika Zetterström Senior Director Business Development – Clinical Research Services +46 70 4836 847 annika.zetterstroem@PAREXEL.com

ASIA PACIFIC Brian Yang Corporate Vice President, Business Development +886 2 21769525 brian.yang@PAREXEL.com

Our regional leads would be happy to discuss the Connected JourneyTM and ways we can put it to work for you.

Patient recruitment and enrollment, for example, may be the single biggest driver of costs, takes the longest and is highly volatile. In the Connected JourneyTM we regularly use real world data assets to help identify the sites and physicians who are likeliest to have the patients needed for a particular study. On the process side, the Connected JourneyTM makes it easier to help doctors use the right systems to get those patients into the trial.

“ Just because an investigator has had previous success doesn’t mean they will be successful in the next study,” says Paul Evans, Corporate Vice President of Global Site Solutions at PAREXEL. “We work with investigators who have figured out how to address the challenges of patient recruitment.”

ENABLING NOVEL APPROACHES. PAREXEL’s Connected JourneyTM opens up new ways complex challenges can be addressed on multiple fronts.

In regulatory submissions, there’s been a major transition, from documentation that is focused solely on safety and efficacy, to evidence that also shows value to the healthcare system. And while “Access” used to only mean getting a drug to market, now it’s also about keeping it there. In both situations, the Connected JourneyTM enables us to integrate different kinds of evidence into our work to help tell the smartest possible stories.

But these are just a few examples. The real transformational power of the Connected JourneyTM lies in its ability to help us work smarter and achieve quantifiable results at every stage, even as the industry evolves. And we look forward to realizing it with you.

3-6. Source: KMR Group - Clinical Group, 2015

7. Source: PAREXEL Internal Research.

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PAREXEL International Corporation | PAREXEL.com 195 West Street, Waltham, MA 02451 | +1 781 487 9900

©2017 PAREXEL International Corp. All rights reserved.

PAREXEL is a leading biopharmaceutical services company. Our Connected JourneyTM is a unique, purpose-built ecosystem that enables robust data and rich analytics to inform key decisions at every stage for a smarter route to market.