Pharmacovigilance Safety Database Services

A Global Pharmacovigilance Safety Database sits at the heart of the vigilance system for medicinal products and devices. It is the main repository for collected safety information for the company’s product(s), it facilitates the reporting of individual and aggregate safety data to authorities and third parties and provides a key source of information for ongoing detection of safety signals and evaluating the risk-benefit balance of the product. It is therefore vital that the pharmacovigilance safety database is up to date with the latest reporting requirements, and has been validated to ensure it meets the needs for regulatory compliance and business purposes.

QVigilance offers a fully managed and maintained hosted database solution with the industry-leading Oracle Argus system. Providing significant cost savings, otherwise incurred with the implementation and maintenance of in-house systems and their expensive downstream upgrades, to maintain compliance with ever-changing regulatory expectations.

Experience across multiple PV safety Databases:

  •    ARISg
  •    IRT
  •    PV Works
  •    SafetyBase Interchange
  •    Own In-house customers systems and require case
       processing, reporting and aggregated data retrieval

 

Why choose Oracle Argus?

QVigilance’s Oracle Argus is a fully validated safety database, which enables quality and efficiency in handling safety data. In accordance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP), this allows continuous evaluation of the risk-benefit profile of products throughout the lifecycle of the product. Our database enables 21CFR part 11/Eudralex Volume 4 Annex 11 compliance and is compliant with inbound and outbound transmission of Individual Case Safety Reports (ICSRs) in both ICH-E2B-R2 and most significantly, the latest ISO ICSR ICH-E2B-R3 format.

The main features of Argus version 8.1 include global case processing, signal detection, detailed analytics, electronic case intake, electronic expedited reporting, risk management, periodic reporting and submissions; as well as the capacity to hold large volumes of cases and associated source records. All these features facilitate faster and better-informed safety decisions, in line with constantly evolving regulations.

Why choose us to host your pharmacovigilance safety database?


We offer set up and hosting of Oracle Argus, which avoids the cost and delay of setting up a compliant safety processing system in-house. Qvigilance has configured and validated an Oracle Argus version 8.1 gold schema instance, a copy of which can be rapidly set up and deployed for a new customer as their global safety database. We offer individual customer tenancies (database instances) within the safety database to ensure segregation and confidentiality of data, and to allow efficient maintenance of the system.

Our web-based hosted platform enables clients to securely access the database, for increased oversight of their data. Workflows are managed within the database, allowing configuration of client-specific timelines and requirements. Case reports and aggregate data outputs are produced directly from the safety database according to regulatory standards. QVigilance will maintain the safety database throughout project duration, including management of MedDRA and WHO Drug Dictionary updates, installation and validation of patches, and regular access review.

Our tailored solutions can take on full, end-to-end case processing activities, or hybrid approaches with direct customer input into workflows.

The QVigilance PV team have extensive user-end training and are experienced in using the system to its full potential. Our goal is to support customers whatever stage of the product lifecycle they may be at, from managing the risk-benefit profile of products on the market to helping bring drugs to market quicker. All this must be done whilst meeting strict regulatory requirements and a fully validated comprehensive safety database is a fundamental part of achieving this.

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