Best Practices in Site Start Up

Report Overview

It will come as a surprise to no one that site start up is a challenging part of the clinical trial process. Various pieces of research into this topic have put the length of site start up (site selection through activation) in the ballpark of 7 to 10 months. In the pharma world, with patent cliffs and competitor products looming, each day is valuable and every delay is costly.

For this research, we gathered verbatim insights into the practices that create site start up efficiency, the causes of inefficiency, and new practices being undertaken in an effort to improve efficiency. To get multiple perspectives on the site start up process, we surveyed people with site start up responsibilities at sponsors and CROs as well as people working at clinical sites, such as clinical investigators and study coordinators. We asked our respondents to provide thoughtful looks into the challenges and best practices they associate with seven different steps of the site start up process. This report shares actionable practices to improve site start up efficiency.

What you will learn:

Study Sponsors, CROs, and SMOs

• Which steps of the site start up process are considered the most problematic among both sponsor/CRO respondents and site personnel
• Practices that our respondents strongly believe are critical for improving efficiency or fixing inefficiencies
• How industry peers track start up performance
• Strategies that start up professionals say are working, strategies that have failed, and what they’re working on next to improve efficiency

Clinical Trial Sites

• Insight into the site start up activities that study sponsors and CROs are most actively working on to improve their efficiency
• How sponsors and CROs feel about working with SMOs in regards to increasing start up efficiency
• Advice to sponsors and CROs for how to improve start up speed
• Best practices for improving study start up speed used by investigators and study coordinators

Major Topics:

• Site Start Up Challenges
• Verbatim Analysis: Causes of Efficiency/Inefficiency and New Practices Planned
• Site Start Up Strategies and Performance Measurement
• Sponsor and CRO Site Start Up Performance
• Study Data: Sponsors/CROs
• Study Data: Sites