CROMSOURCE provides full safety management and vigilance for sponsor’s pre- and post-market clinical trials. CROMSOURCE is experienced in dealing with the disparate safety reporting requirements in different EU countries, as well as the rather different model for safety reporting in the USA. Our medical monitors are available 24/7 in all time zones in order to address any safety issues as they arise.
Safety reports are managed proactively so that the sponsor and investigator teams are fully invested in any safety decisions made or expedited reports submitted. Experienced CROMSOURCE medical staff will interface with regulatory authorities (including the FDA) and sponsors to ensure that any safety issues that arise are dealt with efficiently and pragmatically.