Key Features/Benefits

  • Automate inbound receipt of case data from any source
  • Inbound fax and email with automated OCR
  • Integrates with any safety system including ARISg and Oracle Argus
  • Paperless case management with automated workflow assignment
  • Integrated with agReporter (mobile data collection)
  • Advanced duplicate case checking
  • Communication and follow-up tracking

Background

Based on recent trends, all drug and device manufacturers are predicting a significant increase in the number of potential adverse event reports from a variety of different sources.  This anticipated proliferation in the volume of case reports brings into focus the risk of incorrect reporting as the traditional method of case processing is both inefficient and time consuming.

For every initial safety case logged, there is usually at least one follow-up report, and often dozens.  SOPs mandate that companies track follow-up attempts to prove that they have met due diligence requirements.  But doing so means they are often buried under incoming information.  Triaging that information is not something that typical safety databases support, so all the steps prior to data entry are usually manual or kept in spreadsheets.  To add to the headache, information can be received from email, fax, call centers, literature and other departments – anywhere.

Inbound Case Receipt and Triage

Inbound Case Receipt and Triage ensures that all affiliates and contract organizations are able to rapidly enter and triage newly-arrived safety items, so that reporting timelines can be quickly and reliably established. It helps rapidly determine whether the items are new, follow-up, duplicates, etc. without a burdensome data entry process. It allows affiliates to focus on local regulations and concentrate their attention on what their particular areas of expertise are, without absorbing all their resources in all the central activities of case processing and reporting.

Inbound Case Receipt and Triage is a unique case triage tool that automates the receipt of adverse event data regardless of source.  With email and fax integration, sophisticated OCR, EDC integration and integration with LifeSphere Mobile MA our mobile data collection module, Inbound Case Receipt and Triage significantly improves your ability to triage and process cases.  Users can perform comprehensive follow-up activity, sending automated follow-up and tracking all case related communications.  Source documents are stored electronically, eliminating the paper chain.

A versatile system, Inbound Case Receipt and Triage can also be used for affiliate data entry by providing affiliates with a simple and cost effective way to perform case entry.  Once complete, cases can be distributed directly to the central safety system for assessment and global report distribution.  As an integral part of your safety strategy, Inbound Case Receipt and Triage can reduce costs associated with AE case processing while improving compliance.

Safety Investigator Reporting