Oracle Argus Safety

• Oracle Argus Safety is a vast platform invented to address the complex pharmacovigilance requirements of the life science industry. 
• Argus Safety’s advanced database helps ensure global regulatory compliance, enables sound safety decisions, and integrates safety and risk management functions.  
• Origination of cases via case entry screens
• Tracking of local data items
• Support for e-signatures
• Duplicate search capabilities
• Local labeling decisions made against local datasheet or license
• Case views provided to appropriate local affiliate
• Pictures of core documents and global protocols such as action items on a worklist.
• Central staging area for evaluating submitted affiliate cases
• Electronic submission abilities
• Reporting and Querying cases taken and submitted
• Audit Trails

With Oracle Argus Safety Pharmaceuticals can:

• Ensure global regulatory compliance
• Make faster, science based safety decisions
• Integrate safety and risk management
• Lower the cost of Pharmacovigilance

ARISg

• It is used to manage crucial drug safety data worldwide. 
• It provides all the functionality needed to manage adverse reaction requirements and adverse event reporting of several regulatory authorizations worldwide. 
• It allows for all pharmacovigilance methods from case entry to automatic generation of resignation ready adverse event (AE) reports etc., 
• ARISg forms a core element of an integrated pharmacovigilance and risk management system, allowing organizations to identify safety risks and monitor their products. 
• ARISg helps advance the management of Adverse Drug reactions using its advanced automation and configurable workflow features.       

PvNET

• PvNET is a a comprehensive pharmacovigilance solution and one of the leading software used in pharmacovigilance with Adverse Event reporting, Adverse Drug reaction (ADR) data management and regulatory reporting of ICSR (Individual Case Safety Report) that goes beyond mere compliance. From early development through post marketing, PvNET helps integrating the safety information, and thus helps users to make critical decisions. PvNET is across the board drug safety successfully audited against GMP standards, 21 CFR compliance and ICH E2B.

The extensive features of PvNET include:

• Workflow which supports to segregate Data Entry, QC (Review) and scientific assessment/medical review.
• Extensive data validation and cross-field validation checks – validate case files for E2B compliance.
• Global Dictionary support and Dictionary management (MedDRA version management)
• Audit records for safety data management activities
• Management Dashboard: Delivers dashboard with the ability to focus on relevant domain providing users with the information to draw attention to anomalies and outliers, making it possible for them to take actions quickly
• Serious Adverse event automated narrative writing & multi lingual text support
• Duplicate case checking
• Centralized triage prior to full case processing

PvNET also has add on modules through which additional features can be added to it.

PvNET has been developed not only to record the adverse events but also analyze and generate various regulatory reports, such as:

• E2B compliant XMLs
• CIOMS
• MedWatch
• ICH approved periodic reports including PSURs, bridging reports and other annual reports.

• VigiBase is a WHO’s global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO’s international drug monitoring programme.
• Uppsala Monitoring Centre (UMC) in collaboration with ‘’Swissmedic’’ has developed ‘’VigiFlow’’, a web-based ICSR management system. VigiFlow functions as a national ICSR database management system and analysis tool, through which cases are sent to UMC.
• It is an all-in-one system that provides PV Intake, Case Processing, AI, Analytics, Submissions / inbuilt  Gateway, Signal Management and Safety Analytics capabilities under one platform.
• It  complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.
• It  provides transparent optimized pricing with no compromise in functionality,
• It provides High performance and efficiency.
• It  is built on a secured regulatory complaint infrastructure.
• It works towards reduction of end user efforts through constant automation and AI capability enhancements.