SGS Successfully Implements Oracle Argus Solution for Drug Safety and Regulatory Compliance

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SGS Successfully Implements Oracle Argus Solution for Drug Safety and Regulatory Compliance

SGSSGS, a leading life sciences, clinical and bioanalytical contract solutions provider, has successfully implemented the market leading Oracle Argus database in response to changing pharmacovigilance requirements for processing solicited and unsolicited adverse events (AEs).

Oracle’s Argus Safety is a comprehensive safety database designed specifically to address the complex drug safety and pharmacovigilance requirements of the life sciences industries.

The system’s advanced database helps to ensure global regulatory compliance, aid faster and more informed safety decisions, and integrates safety and risk management functions.

Argus provides retrospective and real-time analytics for workflow state, case lock and expedited report submission compliance to improve the quality and timeliness of safety case processing and reporting. It also reduces operational risks for both clinical trial and post-marketed pharmacovigilance data.

The multi-tenancy feature in Argus Safety allows multiple SGS clients to reside as separate and unique tenants in a single database with their data completely segregated and restricted to authorised users.

This feature also enables SGS to achieve standard configurations, such as code lists, workflow steps and new user setup across clients, or to have different configurations for specific clients. Additionally, SGS users with greater access can view their work across multiple clients and make more informed decisions.

“We can now use a single database for many clients, which reduces the amount of hardware and resources needed for pharmacovigilance implementation,” commented Rafaël Smets, Head of Medical Affairs for SGS.

He added: “We undertook a careful evaluation of all available systems on the market before selecting Oracle’s flagship safety system. Argus Safety is trusted throughout the life sciences sector for its functionality, reliability, compliance, and ease of use, while ongoing enhancements will meet both regulatory and the industry’s evolving needs.”

SGS is a leading life sciences CRO providing clinical research, bioanalytical, biologics characterisation, biosafety and quality control testing.

Delivering solutions in Europe and the US, SGS offers clinical trial (Phase I to IV) services encompassing clinical project management and monitoring, biometrics, PK/PD modelling and simulation, and regulatory and pharmacovigilance consultancy. SGS has its own clinical unit in Belgium and two Phase I patient units based in Belgium and Hungary.

SGS has a wealth of expertise in first in human (FIH) studies, viral challenge testing, biosimilars and complex PK/PD studies with a focus on oncology, infectious diseases, vaccines, and respiratory therapeutics.