SimpleCTMS Provides Validated Electronic Visit Reports ‘Off-the-Shelf’

Trial By Fire Solutions, a leading eClinical solution provider specializing in clinical study management applications is now offering validated electronic visit reports (EVRs) as a standard SimpleCTMS offering. Electronic visit report templates for prestudy, initiation, routine monitoring and closeout monitoring visit types, have been functionally validated for immediate client use. Additionally, standard validated functionality includes approval workflows, collaboration tools, electronic signatures, report attachments, and email alerts for the handoff events along the way. Performance reports are available for management trending and oversight of monitor and approver timelines compared to stated monitoring plan requirements.

Client use of validated EVRs
“Recently, one of our clients requested to learn more about the eVisit Report functionality offered in SimpleCTMS. Although the company had monitoring report templates, they recognized the content was outdated and the workflow of the review and approval process too manual for their global team. They further recognized that having validated electronic visit reports would be a much better company initiative to adopt than an overhaul of their templates, said Nancy Cecchettini, co-founder and Chief Product Officer.”

“Upon seeing the SimpleCTMS templates, they were pleased to learn that common report elements required by their team such as integrated action items, protocol deviations, informed consent and SAE tracking are available as standard functionality. Additionally, the client was pleased to learn of the benefits of utilization of SimpleCTMS for workflow improvements such as providing attachments for reviewer transparency with the draft EVR and performance metrics reports to trend across CRAs and regions.  In keeping with prompt and effective customer support for client needs, the Trial By Fire Solutions team was able to make the visit report templates available to the requested studies, create a few example reports for reference and provide a tailored training session for the CRA field team within one week.”

For more information on how SimpleCTMS can help your organization optimize clinical study management or to see an online demonstration, please visit