Lets run the numbers, reducing trial costs

Consider the following client case study (Inspire Pharmaceuticals):

Study Overview
Phase 2 20 Sites 138 Subjects Active enrollment period of 8 months with 1 month of treatment/follow-up

Enrollment Parameters

Site Activation is binomially distributed Subject enrollment is Pareto distributed Monitoring Parameters

Interim site monitoring can be every four weeks, every six weeks, or Just-in-time during active enrollment. Monitoring visits require 12 hours of preparation, travel, and follow-up. Each subject requires an average of 210 minutes to monitor Each visit on site is rounded up to the nearest half-day JIT monitoring is triggered by enrollment of the first and every third subject thereafter at each site

Click to edit Master title style Click to edit Master title style

RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES

www.clinipace.com

Initiate early to enroll more

As would be expected in a competitive enrollment study, sites that were initiated early enrolled more subjects.
25 9

Subjects Enrolled 20 Active Duration (mo.)

15

10

Click to edit Master title style Click to edit Master title style
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Subjects

Months

Site

RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES

www.clinipace.com

Capacity more closely aligned to enrollment

This graph shows the total number of hours required to monitor all subjects at each site under the three monitoring paradigms.
250.0 Total Monitoring Hours (Q4) 200.0 Total Monitoring Hours (Q6) Total Monitoring Hours (JIT) Subjects Enrolled 20 25

Monitoring Hours

150.0

100.0

Click to edit Master title style Click to edit Master title style
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Site Number

15
Subjects

10

50.0

0.0

RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES

www.clinipace.com

Scheduling monitoring based on elapsed time (q4 or q6 weeks) leads to less efficient deployment of resources than JIT monitoring at lower enrolling sites.
70.0 25

Stop over monitoring poorly enrolling sites

60.0 Hours per Subject (Q4) 50.0

Monitoring Hours per Subject

20

Hours per Subject (Q6)

40.0

30.0

20.0

Click to edit Master title style Click to edit Master title style
Subjects Enrolled 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Site Number

Hours per Subject (JIT)

15
Subjects

10

5 10.0

0.0

RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES

www.clinipace.com

Efficiency creates capacity

JIT Monitoring. is the use of logical triggers based on enrollment, queries, or protocol deviations to allocate monitoring visits rather than conventional use of duration leads to more efficient use of monitoring resources as compared to conventional monitoring
3000 Hours Required On-Site Req'd Total Monitoring Hours (Q4Wk) 2500 Total Monitoring Hours (Q6Wk) Total Monitoring Hours (JIT)

2000

9% 36%

Click to edit Master title style Click to edit Master title style
Hours

1500

1000

500

is particularly suited to studies with competitive enrollment

RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES

0 Hours Required On-Site Req'd Total Monitoring Hours (Q4Wk) Total Monitoring Hours (Q6Wk) Total Monitoring Hours (JIT)

www.clinipace.com

To learn more about how our dCRO methods Click to edit Master can work for you visit: title style www.clinipace.com Click to edit Master title style