E2B Database Pheda

On the one hand, our pharmacovigilance database enables you to manage adverse reaction reports in a structured, online-based manner – including the creation of listings and extensive query options – and on the other hand, using the gateway, you can exchange reports with authorities and partners.

Pheda is a modern system, validated in accordance with the GAMP 5 standard and compliant with E2B(R2) and E2B(R3), that is based on a jointly used SQL database. Each participant manages their data in a proprietary, self-contained database area. The database is accessed via a web browser, so that no software installation is required on the user's side.

Your advantages at a glance

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

Needs-based database use: Basic and Professional version

In the continuous further development of the database, the focus is on usability in particular, alongside the current regulatory requirements. In line with the differing user habits, Pheda is available to users either as a Basic or a Professional version, which contain various functionalities.

The functional tools include, among other things, the reporting of adverse reactions, the creation of tables and listings as well as extensive query options (queries). Via a gateway, Pheda is connected to the European adverse reaction reporting system (EudraVigilance) and thus enables reporting to authorities across Europe as well as data exchange with partners.

Basic version: Powerful and practical

The Basic version of Pheda includes, among others, the following functionalities:

• Clearly structured, user-friendly interface
• Colour coding to distinguish mandatory fields, other E2B fields and administrative / additional database-internal fields
• Capture, management and storage of reports in the proprietary area of the shared database
• Coding of adverse reactions using an integrated MedDRA browser
• Generation of ICSR XMLs for electronic reporting from the entered data
• Sending the ICSRs via gateway software
• Extensive query, evaluation and export options
• Workflow functionality with a role/rights system for quality assurance and to document the four-eyes principle
• Tracking function for reporting obligations (7-, 15-, 90-day reports)
• Option to hand over a report to another user (Transfer Safety Report)
• Document upload option for each entry
• Creation of PSUR tables
• Display / use on mobile devices
• Two-Factor Authentication to increase access security

Professional version: Making full use of Pheda

In addition to the applications of the Basic version, the Professional version lets you employ a wide range of further functionalities, including:

• Flexibly configurable tracking timelines
• Sending of email notifications as a reminder when the reporting deadline is reached
• Sending of email notifications for incoming ACKs and ICSRs in the gateway
• Fully flexible searches – every database field can be searched
• Option to query cases by a keyword (Case Classification)
• Option to save searches (Saved Searches)
• Configurable line listings and result tables
• Bulk export of various export formats
• Key Performance Indicators for the PSMF that can be queried and exported

Individual additional services

Around Pheda we offer you individually bookable additional services, including:

• German- and English-language system training courses (beginner / advanced course)
• Capturing and coding of cases
• Support with EudraVigilance registration
• Testing with authorities of other member states for electronic reporting
• Electronic reporting to authorities
• Participation in the MedDRA group licence
• Free service hotline
• Audit report (joint audit)