ForeSite™ CLINICAL TRIAL METHODOLOGYOpening the Door to Greater Competitive Advantage

PREDICTING SITE SUCCESS

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On average, it costs more than $2.5 billion and takes more than ten years to bring a new therapy to market.1

The clinical development path is riddled with complexity and risk that can stall—or even stop—your journey to commercialization. But done correctly, with the right collaborative partners, you can reduce risk and open the door to greater competitive advantage. ForeSite™ is PAREXEL’s clinical trial methodology that integrates therapeutic area expertise, real-time analytics technology and centralized oversight to reliably predict site

success. It helps you optimize site and study protocol feasibility, forecast optimal country and site locations, and more effectively engage and retain sites and patients. Faster clinical trial design, start-up and execution are possible. ForeSite™ makes them happen.

Our unique integration of people, process, and technology – coupled with decades of deep expertise – enables us to minimize the change orders and rework that plague the industry and add to the cost, complexity and timeline of typical trials.

1. Tufts Center for the Study of Drug Development, March 2016

TAPPING THE POWER OF PREDICTABILITY

PAREXEL’s Strategic Feasibility team is focused on creating well thought-out risk and contingency plans. ForeSite™ brings the systems, data, and skilled personnel to increase the predictability of hitting your milestones and your budget. The result is that by the time we get to study award it is more likely that we have a plan and a bid that aligns to everyone’s expectations.

DATA WE UNCOVER:

• We gather historic and feasibility data for sites and turn it into active knowledge for use in our site assessments.

• We take a multifaceted look at risk, including regulatory, scientific, medical, and statistical protocols; countries and sites; patient types; resourcing; quality, financial, or contractual issues; study design; and the presence or absence of contingencies.

BUILDING A DATA-DRIVEN STUDY PLAN

PAREXEL’s Study Start-Up Team brings decades of experience in successful study start-ups for the largest pharmaceutical companies and the nimblest biotechs.

We utilize our 300+ Site Alliance relationship to help with protocol planning and implementation. Using QUIKSurveys and KOLs at Alliance Sites for rapid fire feedback on protocol design can support our efforts in engaging with the client on protocol viability. In addition:

• We examine both scientific and patient needs during study planning to ensure a balanced approach to meeting critical endpoint. You win and patients win.

• PAREXEL uses social media and email outreach to recruit patients and ensure that existing patient names stay fresh, relevant and up-to-date.

• We also use online outreach, patient advocacy groups and printed collateral to expand our patient database.

• Thanks to PAREXEL’s rich Early Phase database of 40,000 patients, you can retain the knowledge base they build by using PAREXEL’s services from Phase I into Phase II and III.

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The first big challenge of protocol design is that it is feasible. Protocols are becoming more complex; there was a more than 60% increase in eligibility requirements of Phase III protocols in the decade to 2012.2 The second is that it can be adhered to without amendments that slow the process; more than half of trials are delayed at the site level.3

STUDY DESIGN

12.9MONTHS –

PAREXEL AVERAGE TIME FROM FIRST TO LAST

SUBJECT RANDOMIZED.5

PAREXEL MOVES FROM FINAL PROTOCOL AVAILABLE TO

LAST SITE INITIATED IN JUST 4 MONTHS –

12%FASTER THAN THE

AVERAGE CRO.4

2. Tufts University (Http://csdd.tufts.edu/news/complete_story/pr_ir_nov-dec_2012)3. Tufts University http://csdd.tufts.edu/files/uploads/jan-feb_2013_ir_summary.pdf4. KMR Group Clinical Program, 20155. KMR Group Clinical Program, 2015

Complex trials with many parties are hard to get started on time; 80% are released one month late.6 Moreover, under-enrolling sites create a sense of progress while slowing things down; 37% of sites under-enroll.7 PAREXEL’s ForeSite™ Clinical Trial Methodology ensures that study start-up stays on track.

TRIAL ACCELERATION THROUGH CENTRALIZED OVERSIGHT AND A SITE CENTRIC OPERATIONAL MODEL

Study launch progress is monitored by PAREXEL against plans using real-time data, assessing site performance against key criteria at every step.

PAREXEL’s centralized oversight office monitors progress against plans using real-time dynamic analytics. Should deviations be detected, a start-up expert or central office deploys experts as needed. Our scoring process and platform delivers consistent, objective assessment of sites against key criteria at every gate of selection. Weekly Panel Review Meetings ensure no delays or loss of prioritization or momentum.

Our kick-off phase ensures:

• Immediate mobilization of expertise to drive accelerated start-up

• Strategic project planning through cross-functional collaboration

• Risk-informed operational execution plans for client endorsement

• Actionable decisions at kick-off, enabling direct initiation of start-up

THE ART AND SCIENCE OF SITE PROFILING

With a scientific and data-driven approach to back up your site selection, ForeSite™ can move you forward with confidence.

ForeSite™ creates successful trials by using our Site Information Management System (SIMS) for end-to-end scoring for in site selection. SIMS combines past performance data, investigator and patient voices, and predictive analytics to yield consensus with sponsors on acceptable risk.

We analyze your trial protocol deeply and create the ideal site profile based on it. Then we survey prospective sites and pre-qualify based on this data. Our site knowledge enables PAREXEL to make an informed decision on the right countries to go to and provides insights to the number of high-performing sites in each country.

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STUDY START-UP

PAREXEL’S CYCLE TIMES ARE

45%SHORTER IN ONCOLOGY

AND

25%SHORTER IN CNS

VERSUS THE INDUSTRY.8

6. 2005 Cutting Edge Information. Clinical trial delays cost pharmaceutical companies7. Tufts University http://csdd.tufts.edu/files/uploads/jan-feb_2013_ir_summary.pdf8. KMR Group Clinical Program, 2015

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Finding and keeping patients is a complex task; only 10% of trials meet enrollment targets without doubling timelines.9 Also, complications such as foreign tax structures and paperwork can slow payments to sites; 65% do not have enough cash to operate for a full quarter.10

HOLISTIC AND PRAGMATIC APPROACH TO RECRUITING – AND RETAINING – PATIENTS

No one understands patient centricity more than the 30+ experts of our Patient Recruitment and Strategy Group (PRSG). Tools like Consent+, our electronic informed consent platform, help us set new standards for engaging patients and reduced the burden on recruitment.

We use online and traditional channels to raise study awareness at sites and in the local community, helping sites to meet their enrollment goals. (These can include digital and personalized introductory letters, patient and parent brochures, reminder cards, study guides, physician referral letters, physician slide decks and recruitment portals and apps.) Patient communication materials are also created utilizing literacy and health literacy guidelines to aid understanding of what participation will mean for them, facilitating recruitment and also retention in the study. These tactics help articulate that your patients may have a better outcome if they take part in research, even if they receive the placebo.

STUDY EXECUTION

9. Tufts University http://csdd.tufts.edu/files/uploads/jan-feb_2013_ir_summary.pdf10. Tufts University http://csdd.tufts.edu/news/complete_story/rd_pr_january_2015

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PAREXEL’S SITE ALLIANCE PROGRAM GIVES US

UNPARALLELED ACCESS TO:

300+INVESTIGATIVE SITE

MEMBERS IN 28 COUNTRIES

10,300ALLIANCE INVESTIGATORS COVERING EVERY MAJOR

THERAPEUTIC AREA

ACCESS TO ALMOST

10 MILLION PATIENTS

RESULTING IN

40-50%HIGHER RECRUITMENT RATES

THAN STANDARD SITES ACROSS ALL

THERAPEUTIC AREAS.12

11. Tufts University http://csdd.tufts.edu/news/complete_story/rd_pr_january_201512. KMR Group Clinical Program, 2015

A NEW PARADIGM FOR INVESTIGATOR PAYMENTS

One of the biggest challenges for Investigative Sites is cash flow with 65% of sites not having enough cash to operate for a full quarter.11 ForeSite™ is taking an industry leadership position in an attempt to shift the site payment model to make payments based on site visits rather than on the site report. We believe this will completely change the dynamic of trials.

Compensation leads to more engaged site investigators and more satisfied patients when it is streamlined. With PAREXEL’s patient visit-based solution and invoicing, investigator payments can be made within 60 days of patient visit.

COMBINING PEOPLE, PROCESS AND TECHNOLOGY TO ADVANCE YOUR STUDIES

PAREXEL’s ForeSite™ Clinical Trial Methodology combines intelligence with operations in a way no one else can. And we back it up with experience no one else can bring to bear to give you a faster, straighter path to market.

We are always available for a conversation.

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

EUROPE Annika Zetterstroem Senior Director, Business Development +44 1 895 27 6553 Annika.Zetterstroem@PAREXEL.com

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

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

© 2017 PAREXEL International Corporation. All rights reserved.