• Web based, affordable and easily implementable, adverse events management outsourcing services ( 1 day, front office training )
• Improved adverse events management workflow (24 hour turnaround, reduced human error)
• Better, more cost effective information management (high volume reporting, audit trails, reduced FTE requirements)
• Improved regulatory compliance (IRB and FDA reporting)

eMedSafety is a web-based service dedicated to adverse event processing. Site administrators log into eMedSafety to easily create reports when one of their patients experiences an adverse event. They use digital versions of their own customized forms as well as the forms required by their IRB, pharmaceutical company sponsors, and regulators. eMedSafety helps administrators route notices using the Internet, capture signatures electronically, index reports to help clinicians monitor potential safety issues, and maintain records to support compliance audits.

Most of a site's adverse event processing burden is a result of SAEs that occur at other clinical sites. These "off-site SAEs" result in hundreds of incoming SAE notices and protocol change bulletins that must be read, keyed into the unique forms used by this particular site and its IRB, routed to the appropriate physicians, signed, returned and retained-all according to the prescribed timelines and procedures needed to maintain FDA compliance. Today, these processes begin when sites receive paper-based forms that arrive by mail and fax, producing time- and labor-intensive data entry work for highly paid, skilled nurses. E MedSafety intercept the incoming forms and convert the data into the site's own, customized electronic forms to be approved and routed with the click of a mouse, and tracked and stored online.

Today's paper-based adverse event forms require nurses and coordinators to spend considerable time reviewing, re-keying, routing, mailing, tracking and filing information. The eMedSafety service automates these processes in its back office, allowing nurses and coordinators to spend less time with paperwork. E MedSafety enables the sites to become more efficient and operate at the highest levels of regulatory compliance. The service is easy to use, mirroring and replacing existing workflows to speed customer adoption, learning, and success