E2B database Pheda

Our pharmacovigilance database enables structured, online-based management of adverse reaction reports – including the creation of listings and extensive query options – and you can also use the gateway to exchange reports with authorities and partners.

Pheda is a modern, GAMP 5 validated, E2B(R2) and E2B(R3) compliant system based on a shared SQL database.

Each participant manages their data in a company-owned, locked database area.
The database is accessed via a web browser, so that no software installation is necessary for the user.

Your advantages at a glance:

• E2B-compliant database in R2 and R3 standard
• Versatile database functionalities
• User-friendly software tool
• No software installation at the user (“Software-as-a-Service”)
• Password protection of company data
• Independent management of reportable and non-reportable adverse reaction reports by users
• Cost reduction and transparency through pooling effect
• Individually bookable service tools
• Comprehensive quality management – validated system in accordance with the GAMP 5 standard
• Continuous further development
• Interdisciplinary project team (pharmacovigilance and IT)
• Support hotline

Demand-oriented database use: basic and professional version

In addition to current regulatory requirements, the continuous development of the database focuses in particular on usability.
Depending on the different user habits, Pheda is available to users as either a basic or professional version, which contain different functionalities.

The functional tools include the reporting of side effects, the creation of tables and listings as well as extensive query options.
BPI-Pheda is connected to the European adverse drug reaction reporting system (EudraVigilance) via a gateway, thus enabling reporting to authorities throughout Europe and data exchange with partners.

Basic version: Powerful and practical

The basic version of Pheda includes the following functionalities:

• Clearly structured, user-friendly interface
• Color coding to differentiate between mandatory fields, other E2B fields and administrative / additional database-internal fields
• Recording, administration and storage of reports – adverse drug reaction reports, incl.
  non-reportable reports – in the company’s own area of the shared database
• Coding of side effects with an integrated MedDRA browser
• Generation of ICSR-XMLs for electronic reporting from entered data
• Sending ICSRs via gateway software
• Extensive query, evaluation and export options
• Workflow functionality linked to a role/rights system for quality assurance and proof of the dual control principle
• Tracking function of the reporting obligation (7-, 15-, 90-day reports)
• Possibility to transfer a report to another user (Transfer Safety Report)
• Document upload option for each entry
• Mapping of workflows – incl.
  Assignment function of reports
• Creation of PSUR tables
• Display / use on mobile devices – including tablets and smartphones
• Two-factor authentication to increase access security

Professional version: make full use of Pheda

In addition to the applications of the basic version, you can use a variety of advanced functionalities with the professional version, including

• Flexibly configurable tracking timelines
• Sending email notifications as a reminder when the registration deadline is reached
• Sending email notifications for incoming ACKs and ICSRs in the gateway
• Fully flexible searches – any database field can be searched
• Possibility to query cases according to a keyword (case classification)
• Saving option for searches (Saved Searches)
• Configurable line listings
• Configurable results table
• Bulk export of various export formats
• Display of reaction severity and racial group in the line listing
• Key performance indicators for the PSMF can be queried and exported

Individual additional services

We offer you individually bookable additional services around the Pheda.

These include

• German and English-language system training courses (beginner / advanced course)
• Recording and coding cases
• Support with EudraVigilance registration
• Testing with authorities of other member states for electronic reporting to these authorities
• Electronic reporting to authorities
• Participation in the MedDRA group license
• Free service hotline
• System training courses – either in German or English
• Audit report (collective audit)