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Pharmacovigilance Safety Database

Global Safety Database - Oracle Argus Verson 8.1

Quanticate is pleased to offer Argus verison 8.1 as part of our full Pharmacovigilance services

Why Oracle Argus?

Oracle Argus is a fully validated E2B (R3) compliant safety database, which enables quality and efficiency in handling safety data. In accordance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), this allows continuous evaluation of the risk-benefit profile of products throughout clinical and post-marketing development.

Oracle Argus is a leading industry-acclaimed Pharmacovigilance database, and the latest version 8.1 offers improved safety functionality. The main features of Argus 8.1 include global case processing, signal detection, detailed analytics, electronic case intake and electronic expedited reporting  in both E2B(R2) and E2B(R3) formats, risk management, periodic reporting and submissions; as well as the capacity to hold large volumes of cases. All these features facilitate faster and better safety decisions, in line with constantly evolving regulations.

 

Why Quanticate?

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 comprehensive safety database is a fundamental part of achieving this.

We offer set up and hosting of Oracle Argus 8.1, which avoids the cost and delay of setting up a compliant safety processing system in house. Through Oracle Argus 8.1 we offer individual customer instances, which allow securely controlled access to customer-specific safety data and efficient maintenance of the system. Our tailored solutions can take on full, end-to-end case processing activities, or hybrid approaches with direct customer input into workflows.

Our team have extensive user-end training and are experienced in using the system to its full potential.

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