Adverse Event Reporting Service (eMedSafety)
The eMedSaftey Software as a Service (SaaS) addresses the Safety Reporting needs of clinical trials, enrolled patient populations, IRB’s, and drug and device manufactures alike. eMedSafety provides document translation, Adverse Event Reporting, and dissemination of information to affected or selected end users or participants.
Adverse Event Reports result in hundreds of notices and protocol change bulletins that must be manually read, keyed into IRB and clinical site-specific forms, and routed to signature. Once signed by the physician, the paper forms must then be manually returned to the clinical coordinator for proper physical retention and storage.
The entire process, of course, must occur within the FDA’s prescribed timelines and within the FDA’s procedural rules in order to maintain FDA compliance. Moreover, the process must fulfill divergent requirements from other federal agencies and organizational entities. Such a complex manual model for managing the process of adverse events is not only time and labor intensive but also prone to human error and necessitates extremely tight coordination between physicians, skilled nurses, and clinical staff.
This is where the eMedSafety service comes into play. eMedSafety extracts information from Adverse Event Reports and enters the data into your eMedSafety database for subsequent electronic distribution to your clinical trials network, affected parties, stakeholders, and/or participants. Automation of this process can save researchers and device manufacturers 50 to 75 percent of the effort that would normally be invested in the adverse event reporting and distribution process. Convert these person hours into cost savings, and you can quickly ascertain the value of eMedSafety to your clinical trials efforts.