Site Start Up: Best Practices For Success


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.


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
  • 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

ISR understands that you’re looking for confidence in your market research. With ISR, you’ll consistently receive

  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

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