DESIGN

START-U

P

NOITUCEXE

PATIENT

RE C R UIT M E N

T

Overcomingrealities

CO

MPENSATIONReducing

investigatorand patientfrustration

STRATEGIC

F E A SIBILIT

Y

Avoiding amendments

STUDY

P L A N NI N G

Sticking totimelines

STUDY

L A U N C H

Driving to the same

coordinatedendpoint

SITE ID

AN

D S E L E C TION

Creating a consistent

approach

VARYING STANDARDS OF CARE

Standard drug dosages can vary by country, complicating

global trials by creating variability in results.

COMPLEX PROTOCOLSNarrowly defining the patient population may seem to increase the odds of trial success, but it can cripple the study by resulting in too small a pool for meaningful results.

Eligibility requirements for average Phase III protocol (2002-2012)2

62%INCREASE

SITE SUITABILITYSuccess in one clinical trial does not guarantee it for another trial. Unmet medical needs or different standards of care could impact a site’s ability to perform.

SILOED, PROTRACTED PROJECT PLANNINGComplex trials with multiple partners build inconsistency and confusion into the process, slowing it down and increasing costs.

UNEVEN SITE MANAGEMENTProject management skills, an

experience-based understanding of site relationships, and varying regulatory

processes are required to keep a multi-site trial on-track.

INSUFFICIENT INFORMATION ABOUT SITE ABILITIES AND RISK

Balancing patients and the protocol can be tricky – optimizing around the patient can

compromise efficacy results, while optimizing for the protocol can make

recruitment difficult.

OF TRIALS MEET ENROLLMENT GOALS WITHOUT DOUBLING TIMELINES10

ONLY10%

WEAK/DELAYED OPERATIONAL PLANSOperational plans should be delivered shortly after study award. Allowing time to pass can create rework from changing expectations and timelines.

OF CLINICAL TRIALS ARE RELEASED ONE MONTH LATE6

72%

FOREIGN REGULATORY REQUIREMENTS & OTHER BOTTLENECKS

Foreign tax structures, currency exchange and paperwork are foreseeable barriers that rarely

get factored into plans ahead of time. These also add to delays and frustration for sites

waiting for payment.

SLOW SITE PAYMENTSOne of the biggest pain points for sites is the time it takes them to get paid for the work they do causing frustration and demotivating the very people we rely on to be successful.11

LACK OF DATA-DRIVEN PROCESS FOR SITE IDENTIFICATION

Without good site data, selection is often based on familiarity or other subjective

measures – potentially leading to the rejection of sites that may be the only way

to get the right patients.

LOW-ENROLLING AND NON-ENROLLING SITESUnder-enrolling sites are a significant problem because they create a sense of progress while actually slowing the process.

OF SITES UNDER-ENROLL8

37%

More thanhalf of all

trials are delayed at thesite level4

55%

LOW PATIENT ACCRUAL RATESFinding the right patients is a complex task

that can change by the day. Insurance models, patient transportation needs and lack of site resources applied to your trial

can all impact recruitment.

LOW PATIENT RETENTION RATESBecause sponsors, investigators and patients participate in trials for very different reasons, there is a tension

between getting vital data and keeping patients engaged and on-study. PATIENT RESCUES

In all of the optimism and planning of a new study, patient recruitment tactics are often viewed as an unnecessary expense. That is, until enrollment falls behind and the study is in jeopardy.

OF SITES DON’T HAVE ENOUGH CASH TO OPERATE FOR A FULL QUARTER12

65%$

POOR DATA OPERATIONSStandard SDTM data management

is time-consuming and laborious due to many error-prone sequential process steps.

PAREXEL MOVES FROM FINAL PROTOCOL AVAILABLE TO LAST SITE INITIATED IN JUST 4 MONTHS – 12% FASTER THAN THE AVERAGE CRO1

PAREXEL ForeSite™ uses proprietary tools like Pre-screen+ to provide a systematic review of risk underpinned by comprehensive feasibility. This allows decision-makers to optimize protocol design and global placement to achieve predictable delivery.

x4

PAREXEL’s Site Strategy team builds long-term relationships with sites that go beyond individual studies. And we complement them with our Site Intelligence Management System to give insights into investigator performance based on real-world data of 40,000+ patients.

PAREXEL AVERAGE TIME FROM FIRST TO LAST PATIENT RANDOMIZED3

12.9 MONTHS

PAREXEL ForeSite™ uses Country Allocation Technology to ensure a consistent approach to site identification and selection. CAT helps us come to a consensus with sponsors on regions and sites to engage.

PAREXEL START-UP TIMES ARE SIGNIFICANTLY SHORTER THAN OTHER CROs7

21% SHORTER

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

PAREXEL ALLIANCE SITES ACHIEVE BETTER RECRUITMENT RATES THAN STANDARD SITES9

40-50% HIGHERRECRUITMENT

PAREXEL ForeSite™ has taken an industry-leading position to base payments on site visits rather than reports. By using data to ensure each site is fulfilling its role, we can make payments as soon as possible after the patient visit.

PAREXEL PROCESSES NEARLY $500 MILLION IN PAYMENTS PER YEAR

83% ON-TIME RATE

PAREXEL ForeSite™ uses a site-centric operational model with centralized oversight to identify problems early. Critical path management focuses on identifying blockages before they become issues.

PAREXEL ONCOLOGY TIMES ARE FASTER FROM FIRST TO LAST SUBJECT RANDOMIZED5

29% FASTER

# OF DAYS

PAREXEL ForeSite™ integrates the people, processes and technologies of clinical trials to simplify Design,

Start-Up and Execution. We combine intelligence with operations in a way nobody else can. And we back it up with experience nobody

else has. After all, who else has completed more than 7,000 trials covering all therapeutic areas in just the last five years?

The clinical development path is riddled with complexity and risk that can stall—or even stop—your journey to commercialization.

Done correctly, with the right collaborative partners, you can reduce risk and open the door to greater competitive advantage.

PAREXEL can help you take a faster, straighter path from study feasibility and planning through investigator and patient recruitment,

and finally to market. Here are six ways PAREXEL’s ForeSite™ Clinical Trial Methodology shortens the timeline.

SHORTENING THE CLINICAL TRIAL JOURNEY

Learn how PAREXEL’s ForeSite™ Clinical Trial Methodology can make your clinical trial faster at PAREXEL.com/ForeSite

1. KMR Group Clinical Program, 2015 2. Tufts University http://csdd.tufts.edu/news/complete_story/pr_ir_nov-dec_2012 3. KMR Group Clinical Program, 2015 4. Tufts University http://csdd.tufts.edu/files/uploads/jan-feb_2013_ir_summary.pdf

5. KMR Group Clinical Program, 2015 6. 2005 Cutting Edge Information. Clinical trial delays cost pharmaceutical companies 7. KMR Group Clinical Program, 2015 8. Tufts University http://csdd.tufts.edu/files/uploads/jan-feb_2013_ir_summary.pdf

9. KMR Group Clinical Program, 2015 10. Tufts University http://csdd.tufts.edu/files/uploads/jan-feb_2013_ir_summary.pdf 11. Society for Clinical Research White Paper: Site Payments, October 2016 12. Tufts University http://csdd.tufts.edu/news/complete_story/rd_pr_january_2015

FOOTNOTES