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International Clinical Trials

Three-Fold Solution

Astonishingly, the same four problems that delayed trial
start-ups 20 years ago are still doing so today; very little has
changed. Sponsors, CROs and investigator sites consistently
name redundant training and certification, budgeting
and contracting issues, vendor relations and scheduling
concerns as the top reasons that site activation can take
up to a year (1).

Certainly, these are not the only issues that cause stoppage.
Feasibility studies, regulatory matters and institutional
review board (IRB) approvals play their part, but the ‘big
four’ remain the same. However, stakeholders can embrace
a three-fold solution to speed up trial start dates, which
has the potential to slash site activation times to as little
as 30 days.

The ‘Big Four’

Before turning to the solution, having a clear
understanding of the problems preventing swift site
activation is important.

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Sean Stanton is Senior Vice President Global Operations at Bioclinica Research Network. He has dedicated the last 25 years of his career to creating successful, high-performing research sites and, to date, has led the start-up of 25 trial sites, six inpatient hospitals and 19 outpatient clinics. More than 5,000 trials have been conducted at these sites, leading to over 50 drug approvals, and, in these, he directed recruitment for the screening of 2,000 to 6,000 patients annually. A sought-after industry expert, Sean has brought innovative thinking to research in all aspects of site practice, from purchasing and resourcing to the use of benchmarking and metrics in business planning to guide trial growth.
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Sean Stanton
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