What Is Clinical Trial Readiness?

by Kelly Ritch Jun 29 , 2020 3 min read

The following is an excerpt from our ebook “The Definitive Guide to Clinical Trial Readiness.” Click here to read the ebook in its entirety.

Clinical trial readiness has to do with building systems within a clinical trial that better prepare all project staff for the challenges and responsibilities they will face during the trial. Assuring readiness depends on sponsors’ ability to . . .

  • Assess which teams and individuals truly comprehend trial requirements
  • Predict and monitor risk based on staff’s demonstrated knowledge and confidence
  • Gain actionable insights into staff and site preparedness
  • Address problems as they are taking shape, rather than wait for them to become fully formed

Readiness can relate to sites, staff, and even patients — and its impact can be monumental. Improving readiness can . . .

  • Accelerate site initiation
  • Increase operational efficiency
  • Improve staff oversight
  • Reduce screen failure rates
  • Reduce protocol deviations
  • Improve subject retention
  • Save time
  • Avoid additional costs

A key component of readiness is evaluating and improving the preparedness of personnel at each site.

This includes assessing . . .

  • Clinical skills
  • Subject knowledge
  • Regulatory adherence
  • Patient management
  • Protocol understanding
  • Clinical trial procedure competence

When the staff is evaluated based on readiness, team leaders can . . .

  • Accelerate onboarding for project members entering during the trial
  • Identify both low and high performers
  • Inform clinical operations where they most need to focus time and resources
  • Prioritize sites for initiation and monitoring coverage
  • Predict staff-based risk

This blog post is an excerpt from our ebook “The Definitive Guide to Clinical Trial Readiness.” Click here to read the ebook in its entirety.

New call-to-action

Related Post

3 min Read 15 Sep, 2021

Webinar: Transforming Study Start Up to Reduce Clinical Trial Site Burden

Clinical trials are more complex than ever. And 85% of them are delayed. More screening…

25 min Read 27 Aug, 2021

12 Clinical Trial Software Tools You Need to Run a Virtual Trial

It’s impossible to read an industry publication without hearing about virtual clinical trials, decentralized clinical…

Molly Bryant
Molly Bryant
32 min Read 22 Jul, 2021

Clinical Operations Conferences Roundup: 37 Events that Are Happening in 2021 [UPDATED]

Updated 22 July 2021. 2020 completely rocked the schedule of clinical operations conferences by the…

Molly Bryant
Molly Bryant