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The Global Drug Safety database (ARISg™)
A 21CFR compliant, fully validated safety database is an essential part of Good Pharmacovigilance Practice. An accurate and accessible database allows rapid assessment of data for signal detection, aggregate report production and statutory electronic reporting of cases to the regulatory authorities. PrimeVigilance operate a fully validated system with ARISg™ which is one of the leading industry standard pharmacovigilance databases. Following many years of experience with the system PrimeVigilance can provide this proven system as an option for all operational contracts. As an experienced user we are able to offer an immediate and cost effective system removing the need for either expensive installation and set-up in house or the requirement for employing and training staff to perform data entry, quality control and database searches using a hosted system.
ARISg™ is a complete drug safety database system designed to be user friendly yet still correctly process all pharmacovigilance data. It is widely appreciated within many of the world’s top pharmaceutical companies but is also extensively used by smaller companies. In complete compliance with international regulations, it facilitates management of all the processes associated with individual case safety reports, including:
- All workflow associated with the particular product
- Managing multiple variants of products, for example, medicines, vaccines, combination products, medical devices etc.
- Reception of new data as it arrives
- Data entry
- Data assessment with full multi-lingual support
- Coding & reporting
- Follow up
- Storage of adverse event reporting at any stage of the product life cycle
Key features include the ability to handle:
- Tracking all communication
- Generating automatic reminders & standard letters
- Automated duplicate case checks
Personnel using the drug safety database are assigned roles which ensure maximum security. This means staff re automatically assigned appropriately different levels of access to functions and data to ensure maximum security for sensitive information. Reports are correspondingly generated and distributed allowing only authorised users to view them or, only where approved, to amend reports.
Compliant Pharmacovigilance Terminology
The database is configured to browse and code using multiple versions of MedDRA® and the World Health Organisation Drug Dictionary as required. It can also be configured to work with third party coding applications.
User Friendly Features
Cases are presented only to the correct staff and are represented on case assessment screens where all key information appears on just one screen. Cases can be approved and locked.
The system will accommodate single case reporting sets in a format rapidly providing all information in an adverse experience report. There is a standardised set of management reports, with Business Objects to facilitate ad hoc reporting.
Drug Safety Reporting
The system is designed to facilitate reporting to regulatory bodies from the moment it is implemented for your company. It will also distribute and track cases to third parties according to pre-configured criteria. The system supports a variety of formats including E2B, CIOMS and MedWatch.
For a free consultation on how PrimeVigilance pharmacovigilance services could implement this industry standard drug safety database for your company, call the team on +44 (0)1483 307920.
PrimeVigilance – Compliant and Validated –
just one of the pharmacovigilance services from PrimeVigilance
For more information contact PrimeVigilance today