LEO Pharma Adopts Electronic Data Capture to Streamline Clinical Trials and Regulatory Review

It takes a period of time for LEO Pharma to get access to the data with paper forms. The forms have to be picked up and shipped back to the company; and the data needs to be keyed into the clinical data management system. LEO Pharma designs and manages its clinical trials using Oracle Clinical, an application the company installed in 2002. The move helped increase productivity and data quality, but the company still faced delays getting data into the system in the first place - in large part because LEO still used paper Case Report Forms (CRFs) to record data at each trial site. To minimize such delays, the company recently moved to Oracle's site-based Electronic Data Capture (EDC) system - Oracle Remote Data Capture (RDC) Onsite.