The Changing Face of Electronic Data Capture: From Remote Data Entry to Direct Data Capture

Abstract

For the last 10 years remote data entry (RDE) has been the great white hope of the pharmaceutical industry in achieving three main aims: cutting clinical trial duration time, saving resources, and improving data quality. But where is it? Who is using it? RDE has failed to meet the three aims. The time of the RDE paradigm is past and the future will be shaped by new study site technologies which more and more are able to provide much of the required clinical data directly without the need for the transcription to paper and then reentry to another system. Direct data capture (DDC) from machines such as patient record systems, MRI machines, ECG and EEG technologies, laboratory measurement equipment, and an increasing range of other previously manual data providers will enable error-free and resource-efficient data capture. The substantial reduction and possible elimination of errors will allow early locking of the database and therefore, potentially earlier product launch.