Foresight® Case Intake (PVI)

The Foresight® Case Intake system is a comprehensive solution for capturing Individual Case Safety Reports (ICSRs) or Product Technical Complaints (PTC) electronically from suppliers worldwide (affiliates, licensing partners, call centers, CROs, medical representatives, patient support programs, EDC systems) and automatically importing them into your safety database or complaint handling system.

Foresight® Case Intake solution replaces your traditional paper based, manually intensive, and error prone receipt and data entry process with a web based and paperless system that runs 24×7 and automates manual review and data entry processes for ICSRs and PTCs.

  

Traditional receipt processes typically have many of the following issues:
  • Existing methods of submitting ICSRs and PTCs (fax and e-mail) are unreliable as they allow for the possibility of lost submissions
  • Multiple business processes are required to process different types of ICSR forms submitted to drug safety (firm’s form, licensing partner forms, call center forms, etc.)
  • ICSRs and PTCs are not tracked until sometime after the initial receipt, thus allowing for the possibility that they are misplaced or difficult to locate
  • Every ICSR requires manual review to determine if it meets the criteria for an Adverse Event
  • ICSRs and PTCs are manually data entered into safety database and complaint handling systems, which is time consuming and error prone
  • Resource levels must be continually increased to meet demand driven by increased ISCR or PTC volume
  • Your workforce requires access to information from multiple geographical locations not supported by existing systems
  • Affiliates and other 3rd party organizations do not get timely information about their ICSRs or PTCs
 

Features


The Foresight® Case Intake system allows submitters to utilize a web interface via a PC or mobile device to capture ICSRs or PTCs and then submit them electronically to Drug Safety via a high availability web-based system.    The system also supports importing of E2B files from licensing partners and health authorities.

Foresight’s system stores the information submitted its database in an E2B+ format; automatically validates each submission; informs submitters of issues immediately on-line; and then automatically enters the case into your safety database via the standard E2B+ Import feature of commercial safety systems.  Product Technical Complaints are routed to the complaint handling system to be imported.

Only submissions that have been verified to ensure that all issues have been corrected by the submitter are imported into your safety database or complaint system.

Foresight® Case Intake provides an integrated, world-wide and on-line solution that:
  • Hosted in the Foresight® Cloud
  • Has been in use for over ten years, first at a top 10 pharmaceutical company and has processed over 800,000 submissions
  • Has a robust product neutral interface that Integrates with any safety database/application version whether commercial or bespoke via E2B
  • Web based user interface that uses a very familiar email like “Inbox” per organization to monitor issues with ICSRs
  • Allows each organization to submit ICSRs, PTCs, attachments and source documents online during their local business hours
  • Submitters are informed immediately on-line via their organizational inbox of issues with items  they submitted
  • Submitters can run searches and reports to view status and content of items submitted from their organization or other organizations they are responsible for monitoring
  • 21 CFR Part 11 compliant.  Support electronic signature on all user actions (i.e., require User ID and Password), Provides an audit trail to ensure all events, data, users, and reasons are tracked


Business Benefits


Following are some of the business benefits realized from this system:
  • On-line processes have replaced unreliable paper-based processes with guaranteed delivery methods
  • Many manual review and data entry tasks are automated, so costs are lowered significantly
  • Compliance is improved.  Cases are processed faster and lost or misplaced cases are eliminated
  • Clients are able to process increased case volumes with fewer resources, since Drug Safety only has to process exceptions rather than all cases
  • Data entry resources can be reassigned to other value added tasks
  • Since automated data entry eliminates data entry mistakes, quality assurance reviews of the data entry process can be eliminated
  • Users can access the system during local country business hours for information rather than waiting for central drug safety to answer questions