US Site Auditor/s for Phase 3 Anti-Infective US Study

A small NE-based anti-infectives company pursuing an approval for treatment resistant UTI.  They are approaching the latter half of their ongoing phase 3 and are looking to conduct a 10% audit of the likely FDA inspection sites.  Of the 140 sites a good number of them have not actually enrolled patients, so the number of audits is anticipated to be 8-14- still a moving target, all US based.  They’d like to schedule one or more a month from July 2023 finishing mid December 2023.  Anticipate needing 2 auditors to cover that although if one could cover them all they’d be open to that as well.

Comment