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Adverse Event Management

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.

Primary Focus

  • Automate regulatory workflows
  • Implement operational efficiencies
  • Provide web-based cost effective services

Product Objectives

  • Streamline clinical trials workflows
  • Automate today’s paper-based processes
  • Manage Adverse Event Reporting

Product Overview

  • Software as a Service (SaaS)
  • Available on demand: 24 x 7
  • Technology: Web based, Extensible, Scalable
  • Customizable: Forms, Reports
  • HIPAA Compliant: Security, Audit, Archival

How it works

Registration

  • Receive Start-up-Kit
  • Complete business details
  • Provide information on custom forms and reports

Configuration

  • Manage Users / Role
  • Manage Sponsors / IRBs
  • Manage Protocols / Drugs /Toxicities
  • Approve custom forms / reports

Ongoing Workflow

  • Upload Safety Reports
  • Upload Consent Forms
  • Receive standard and custom reports
  • Approve and Process

Features

Content Management

  • Digitize and manage information
  • Data Conversions using intelligent forms
  • Search and archival capabilities
  • Data versioning

Flexible Output

  • Standard forms and reports
  • Custom forms, reports, and summaries
  • Data export to in-house systems

Workgroup Automation

  • My Tasks
  • Notifications and Alerts
  • On-line signatures and approvals

Key Benefits

Improved Workflow

  • Timeliness: 24 hour turnaround
  • Eliminate human error
  • Search and archival capabilities
  • Data versioning

Information Management

  • High volume report handling
  • Conversion to custom formats
  • Audit trail of system access and data modifications
  • Maintenance of historical records

Regulatory Compliance

  • IRB reporting
  • FDA reporting
  • Reporting as per protocol / sponsor guidelines