Successful Inspection by FDA of Prosoft Clinical 5/31/2017
Wayne, PA - 31 MAY 2017 Prosoft Clinical (“Prosoft”), a full-service clinical research organization with over 20 years’ experience in the design, conduct, and analysis of clinical studies, is pleased to announce that the US Food and Drug Administration (FDA) has just completed a clinical study audit at the Wayne, PA facility. No critical findings were noted and no Form 483 was issued. This 3-day audit was conducted from May 23 - 25 in support of the recent submission of an NDA with two ...