Mock FDA Inspection

An innovative biopharmaceutical company focused on development and commercialization of medicines to treat renal diseases were in need of an urgent mock Food and Drug Administration (FDA) inspection.
Read More

Quick Response Needed for Cause Audit

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.
Read More

Clinical Process Roadmap

A global medical device company with clinical operations staff in multiple locations that had grown through acquisitions wanted to harmonize their SOPs into a single repository.
Read More