Quick Response Needed for Cause Audit

SITUATION

A small pharma company partnering with a government agency on a clinical program learned that FDA planned to inspect one of their top-enrolling clinical sites in conjunction with a significant finding for another sponsor.

SOLUTION

  • Within a week, Halloran mobilized an audit team to audit the site in advance of the FDA inspection
  • The Halloran auditors conducted a thorough review of data while managing multiple stakeholders in attendance
  • Halloran also worked with the sponsor to prepare an audit plan for the remaining sites, vendors, and internal functions to satisfy the government agency’s requirements

VALUE

Due to Halloran’s quick response, the sponsor could address its concerns about the site in advance of the inspection.  Thanks to Halloran’s professionalism, the sponsor was able to maintain cordial relationships with the site and its government partners.