ExtraView Adverse Events Solution


 ExtraView Adverse Events is a web-based adverse event management and reporting system that features unprecedented flexibility and ease of use. Used by the world’s largest medical device and pharmaceutical companies, ExtraView Adverse Events is the foundation for global capture, analysis, and resolution of adverse events related to medical device, treatment and diagnostic systems.

“Early identification and reduction of potential risk is a key benefit of an adverse event reporting system.”
--Alfonso Serrato, President & CEO, BioRes Medical Inc.
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Pervasive Adverse Event Reporting
ExtraView Adverse Events provides powerful web-based tools that display and manage incidents directly from any workstation using a standard web browser. Common users include:

  • Safety & Regulatory Engineers
  • Regulatory Affairs
  • Principal Investigators
  • Product Development Engineers
  • Field Service Engineers
  • Other Health Care Professionals

Use ExtraView Adverse Event defaults or create your own fields and layouts

Secure Global Access
Many life science organizations deploy products and expert teams in multiple geographic locations. ExtraView Adverse Events utilizes the Internet to provide secure, controlled access to any person you deem necessary — worldwide. With ExtraView Adverse Events, no client software is necessary other than a standard Web browser. A centralized Web-based system saves both maintenance and audit costs.

Eliminate Paper-Based Systems
Paper-based tracking systems make it difficult to link remote teams, diverse suppliers and contract teams into one cohesive system. ExtraView Adverse Events replaces paper-based systems through electronic records, authenticated signatures and comprehensive audit trails. ExtraView Adverse Events also offers a gradual transition from paper-based systems through the option to attach unlimited digital documents to each record as a fail-safe record system. ExtraView Adverse Events also supports the conversion of stored electronic data and reports into standard reporting documents such as the FDA MedWatch 3500 and 3500A forms.

Exceed FDA 21 CFR Part 11 Requirements
ExtraView Adverse Events provides full compliance with FDA requirements for electronic signatures, electronic records, and audit trails. ExtraView Adverse Events is simply configured so that electronic signatures become mandatory on select insertion, deletion or update of records. ExtraView Adverse Events also records complete audit trails on all login, administrative, and record-level activity.

Stay on Schedule
ExtraView Adverse Events provides a highly configurable notification system that channels important information to the appropriate personnel--instantly. Wireless devices such as email-capable telephones and wireless PDAs can also receive up-to-the-minute updates. Within the notification text, a single click will allow recipients to view or edit the appropriate record through a Web browser interface – no platform issues or client code to worry about.

Protect Staff and Patient Information
ExtraView Adverse Events presents a secure, role-based system where each data item may be given read-only, write access, or no access privileges for each user role. Complete control over multiple levels of user access is provided to the screen, record and field level. ExtraView Adverse Events also gives the option to share filtered data with partners, CROs and other select groups. Notification content is also customized according to the user class of the recipient. Certain user groups see only the appropriate information. For example: ExtraView Adverse Events can send automatic notification to field staff as to the status of their request or case. Each notification is stripped of whatever data you deem private.

Generate Standard and Custom Reports and Forms
ExtraView Adverse Events reports give ‘the big picture’ without the need for merged reports and costly data conversion. Create MEDWATCH, PSUR and CIOMS reports online, as well as statistical and trending reports to measure improvement progress. Individuals may create and save personalized reports based on custom criteria and filters. ExtraView Adverse Events reports, statistics and summaries can export to HTML, PDF, text, XML, Microsoft Word, or Microsoft Excel formats.

Reduce or Eliminate User Training
ExtraView Adverse Event’s intuitive browser-based user interface is supplemented with user-defined help and field descriptions to eliminate the need for user training. ExtraView adverse Events can present your procedure documentation based on the context of the data in any record.

Eliminate Configuration Programming
Many legacy tools or in-house systems require days to weeks of custom programming to simply add a process, workflow rule, or new sub-product line. ExtraView Adverse Events manages these tasks with just a few clicks through a web-based interface.

Collect Relevant Quantitative and Qualitative Data
Individual fields and/or entire sub layouts may appear based on the context of the entered data. ExtraView Adverse Events fully supports the concept of ancillary questions through automatic visibility of follow-up fields based on the answers provided to previously asked questions.

Exchange Data with Other Applications
ExtraView is provided with a powerful API and Command Line Interface that allows it to be integrated with other applications. HTML, XML, Java and direct database connections make ExtraView fit well within any organization.

Top Tier Professional Services
Professional services are available for ExtraView Adverse Events installation and configuration. Experienced members of the ExtraView team will work side-by-side with your staff to analyze your unique needs and create the best possible customization of ExtraView to fit your processes.