The Utilization of a Fax Program to Computer Process Case Report Forms Resulted in a Speedier NDA in a 13 Site Clinical Trial

Abstract

Galderma Labs recently completed a multi-center trial that compared the time to final NDA for lotion, gel and cream forms of an acne-related retinoid product (Adapalene^TM). the lotion and gel versions of Adapalene were tested with Galderma's traditional methodologies. the differentiating factor for the cream was the use of remote case report form collection fax technology. the cream study, using computer and fax technology, resulted in a quicker time to NDA for the cream than for the lotion and gel. This was the largest faxed CRF study ever done.