eMedSafety will be a web-based service dedicated to adverse event processing. Site administrators will log into eMedSafety to easily create reports when one of their patients experiences an adverse event.
They will use digital versions of their own customized forms as well as the forms required by their IRB, pharmaceutical company sponsors, and regulators. eMedSafety will help 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 laborintensive
data entry work for highly paid, skilled nurses. eMedSafety will 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