Pharmaceutical companies, CROs and clinical sites spend millions to manage the vast amount of paperwork that regulatory agencies require during the drug and device development process. Currently, each clinical research site must maintain source documents for the required document retention period. In today's world, with nearly universal access to computers and the Internet, it is inefficient and risky to maintain paper documents.
What Is Target e*CTR®?
Target e*CTR® is software that allows the clinical study sites to perform direct data entry into any EDC system, and at the same time generates a read-only electronic document, which can be designated as the primary source data (eSource). These data, maintained in a secure, read-only trusted 3rd party environment, are available to the clinical study sites, monitors and regulatory agencies in a human readable format.