Aligning Drug Safety and Regulatory Compliance with Argus Safety Software

Pharmaceutical companies are increasingly focusing on holistic view of product information and safety information beginning from clinical trial development and extending it to post marketing surveillance. Argus Safety Software is a comprehensive platform specialized in solving life sciences industry’s complex pharmacovigilance requirements. Overall, its advanced database helps ensure global regulatory compliance, enables sound safety decisions and integrates safety and risk management functions.

The login screen appears as shown:

The following illustration shows the design and location of the individual components under the main Argus Console Menu.

Worldwide Regulatory Compliance

Global regulations and guidance including EMEA, FDA, ICH, MHLW, etc are necessary to follow and all life sciences organizations must comply with them and other myriad of national authorities. However, industry is facing challenges to manage its worldwide reporting obligations due to extensive license partnerships. Therefore, companies depend on Argus Safety to help manage their regulatory compliance in a timely and proactive manner.

With the flexible configuration, Argus safety can model virtually any business processes supporting case management, reporting compliance and license partner network.

Note: The menu items that you can access depend on the security permissions that are defined for your account by the administrator.

Argus Safety supports reporting through robust and comprehensive reporting system which allows users to customize according to the respective regulatory requirements. Advanced automation features such as “Auto/Force Distribute” and “Auto Submit”, it enables full compliance and lowers the reporting cost.

Faster Decision Making and Better analysis of Safety Data

Argus Safety Software is developed while taking into consideration the needs of the industry and continuous inputs from professionals belonging to leading life sciences companies and industry. The main focus is to ensure effective and efficient safety management information. The system is designed to avoid any information leak and faster data entry. It encompasses dynamic workflows, work list management, company-defined reporting rules and extensive automation eventually leading to maximum case processing efficiency.

Since the system doesn’t require any SQL or support from IT department at the end user level, safety data is readily available for timely review and reporting. Other modules are also well integrated with Argus Safety thereby providing the ability to easily reconcile SAEs from clinical trials and update periodic safety reports. Expedited Reporting Screen as shown below:

Overall, objectivity of Argus Safety allows pharmacovigilance departments to focus on drug’s effectiveness at a lower operating cost which enable the pharmaceutical company to gauge better understanding of business process efficiency. Argus Safety provides clear and concise insight into drug’s safety and tolerability profile which further aid in taking better and timely decision on products and portfolios.

Interactive Reconciliation Report Screen:

Aligning Safety and Risk Management

Argus Safety is designed to provide complete end-to-end solutions to its users regarding the safety and risk management needs. It provides comprehensive tools for expedited reporting, periodic reporting, SAE reconciliation while managing product’s risk profiles in real time.

Argus Safety has native risk management capabilities to address regulatory requirements and manage a product’s benefit:risk profile, including reporting automation using advanced conditions, documentation storage, collection of information for advanced visualization and for tracking pregnancy registries. In addition, it can be seamlessly integrated with signal detection and management systems to proactively mine safety data. Companies can leverage the Argus Safety suite to ensure a proactive approach to managing product safety, from clinical development to post-marketing.

Moreover, advancement in technology creates a huge demand for skilled professionals who can deliver and perform at an increasing pace with precision and accuracy. Institutes and colleges provide skilled training for Argus Safety Software which would enable professionals to work on advanced software.

Hands on training on the software will allow incumbents to understand data entry and analysis vis-a-vis will enable them to perform their duties at a greater pace. IGMPI, a QCI approved institute, offers comprehensive training module on pharmacovigilance involving live training on Argus Safety Software. Instructor Led Training is a live Training course that covers the basic and advanced concepts of managing drug safety data using the Oracle Argus application. The course starts with an overview of Oracle Argus Safety 7.0.2 and then covers a more detailed look at the various database features, case entry, workflow and reporting. It is intended for students and clinical research professionals who are willing to make a career in Pharmacovigilance using the Oracle Argus platform.

At the end of this program you will be eligible for the following job roles:

Drug Safety Associate
Pharmacovigilance Associate
Argus Safety Specialist
Case Processing Associate