The document discusses findings from a 2018 survey on clinical operations. It shows that 83% of clinical leaders are taking action to streamline study start-up processes, which currently take around 8 months on average. Poor site selection can cost $2.25 million per non-active or under-enrolling site. The top challenges with study start-up processes are site activation and management of regulatory documents. Organizations aim to speed up study start-up primarily to reduce trial costs and timelines.

1. Streamlining Study Start-up
Findings from 2018 Veeva Unified Clinical Operations
Survey

2. 2Copyright © Veeva Systems 2018
Study Start-up is a Priority Focus
83% of clinical leaders taking action to streamline study start-up
Does your organization have an initiative underway to improve study start-up processes? (Q15)
Percent of respondents using a study start-up systems, N=71

3. 3Copyright © Veeva Systems 2018
The State of Study Start-Up
The average time from site identification to site activation
A decade ago
~7 months
Today
~8 months
Source: Tufts CSDD
http://www.appliedclinicaltrialsonline.com/need-and-opportunity-new-paradigm-clinical-trial-execution

4. 4Copyright © Veeva Systems 2018
The Impact of Poor Site Selection
(N= 15,965 sites participating in 153 global phase II and III clinical trials)
Source: Tufts Center for the Study of Drug Development, 2012
$2.25M
Average expense for
non-active and
under-enrolling sites

5. 5Copyright © Veeva Systems 2018
Study Start-up Challenges
Top challenges with study start-up processes
What are the most challenging, if any, study start-up processes, if any, that limit your organizations ability to speed clinical trials? Select all that apply. (Q.14)
Percent of respondents using a study start-up system, N=71

6. 6Copyright © Veeva Systems 2018
Organizations Aim to Speed Study Start-Up
Top drivers to improve study start-up
To the extent your organization has a study start-up improvement initiative underway, what are the most important drivers? (Q16)
Percent of respondents using a study start-up system, N=71

7. Thank you
• Ashley Davidson: ashley.davidson@veeva.com
•www.veeva.com/unified-clinical-survey/