Pharmaceutical companies are focused on implementing CDISC (Clinical Data Interchange Standards Consortium) standards primarily to ensure compliance with FDA binding guidance that goes into effect December 2016 and similar international standards under consideration.
Spurred by the FDA deadline and actions by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA), companies are focused on how they can overcome barriers and expedite adoption of data standards. It was this reality that led Accenture to undertake a survey of executives at life sciences organizations to assess various dimensions of data standards implementation.
Comment submitted
Submitted comment may not display automatically.