Macro Care Enterprise provides event reporting to ensure all regulatory timelines are met in compliance with ICH, FDA and EMEA standards. With our skills in many languages and knowledge of local medical practices we can communicate clearly with reporters to make sure we receive complete information for each safety event.
Our system also allows sponsors to monitor safety data early to identify product risks and trends. Macro Care Enterprise uses a leading web-based management system to collect, assess and report adverse event information to regulatory agencies, including the EMEA and FDA. We can electronically process SAEs, SUSARs, and ADRs for reporting to sponsors, regulatory agencies, sites and ethics committees.