Safety Database Solutions

PrimeVigilance is equipped with fully supported safety database solutions for a compliant and effective pharmacovigilance system.

ArisGlobal LifeSphere Safety MultiVigilance™ and Argus Oracle Health Sciences Safety. Both systems 21 CFR part 11 fully compliant safety solutions which are an essential part of Good Pharmacovigilance Practice.
They are accurate and accessible databases which allow rapid assessment of data for signal detection, aggregate report production and statutory electronic reporting of cases to the regulatory authorities. 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.

About ArisGlobal LifeSphere Safety MultiVigilance™

PrimeVigilance operates a fully validated, on premise system with LifeSphere Safety MultiVigilance™ 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.

Overview:

• Offers an integrated, highly scalable end-to-end safety platform
• Models virtually any business process, supporting case management
• Provides comprehensive visibility into reporting metrics and compliance
• Supports worldwide operations with single global database
• Able to produce all required regulatory reports, with the exception of R3 E2Bs.
• Enables clients to view and review their data in real time via case workflow

Benefits:

• Fully configurable product and study libraries to enable accurate and consistent data capture.
• As an on premise system all data is stored within our company and within the European Union.
• With Business Objects attached to the system we are able to offer a range of custom query reports to help with signal detection and case management.

About Argus Oracle Health Sciences Safety

A recently new offering, which gives our clients the opportunity to choose to support their pharmacovigilance system with the current best leading cloud based safety database choice.
This system provides a comprehensive pharmacovigilance platform enabling manufacturers to make faster and better safety decisions, optimize global compliance, and integrate risk management into key processes.

Overview:

• Offers an integrated, highly scalable end-to-end safety platform
• Models virtually any business process, supporting case management
• Provides comprehensive visibility into reporting metrics and compliance
• Supports worldwide operations with single global database including Japan
• Leverages a common code base and regular release schedule
• As a cloud based system all patch updates are provided and implemented as and when released meaning you will always be on the latest version of the system.
• Able to import and export both R2 and R3 E2b files

Benefits:

• Make faster, better safety decisions with scientific querying and analytics
• Improve quality and efficiency through safety integration and automation
• Enhance compliance with E2B exchange and periodic reporting
• Conduct global case processing that scales easily to millions of cases
• Speed case review through integration with Oracle Health Sciences InForm
• As a cloud based system, no need to deal with VPN access and firewall issues as the system is accessible anywhere in the world via a URL link.

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