Pharmacovigilance Software’s widely used in Industry
In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace.
Pharmacovigilance software database offers alerts for fast cases, follow-up cases, and reports submission to fulfill regulatory timeline compliance. Any pharmacovigilance safety database must be deposited up to date with the most advanced regulatory requirements and certified to meet international standards and business requirements. Safety databases expedite the reporting of individual and aggregate safety data to authorities and third parties and provide critical information for detecting safety signals and the ongoing evaluation of the risk-benefit profile of the company’s products.
Factors to consider include:
- Costs of maintenance and Implementation
- Hosting models accessibility
- Previous experience
- Interoperability and Compatibility
Let’s know the features of the software.
|Name of the Software
Oracle Argus Safety
|Companies are increasingly shifting their focus to a more holistic view of product safety beginning in clinical development and continuing through post-marketing surveillance. Oracle Argus Safety is a comprehensive platform designed specifically to address the life science industry’s complex pharmacovigilance requirements. Argus Safety’s advanced database helps ensure global regulatory compliance, enables sound safety decisions and integrates safety and risk management functions.
- 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 forms a core component of an integrated pharmacovigilance and risk management system, enabling companies to monitor their products and identify safety risks proactively. ARISg helps speed up the management of Adverse Drug reactions with the use of its configurable workflow and advanced automation features. Users can setup a system that meets their business process and standard operating procedure (SOP) requirements more efficiently by automating the routing of cases as defined in their workflow rules. As with all Aris Global products, ARISg is available on premise and on demand versions.
- 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 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
- ICH approved periodic reports including PSURs, bridging reports and other annual reports.
|VigiFlow, VigiBase were used in post marketing surveillance
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.
While we have discussed many Software’s in Pharmacovigilance, Oracle Argus Safety is a preferred method for managing drug safety data management. Thus the knowledge of Oracle Argus Safety is quite advantageous to stay connected in the industry today.
For profound insights into the world of Pharmacovigilance, visit our Gratisol Labs website.
Want to explore a career in Drug Safety and Pharmacovigilance? Join our certification or Advanced Certified program in the Pharmacovigilance program and kick-start your career in Pharmacovigilance and get experience working in the Argus Safety database.