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 | Distinctive Features |
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
|
ARISg | - ARISg is also one of the most employed software in Pharmacovigilance used by pharmaceutical firms..
- 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.
|
AB Cube: SafetyEasy | - AB Cube Safety Easy is a compliant-ready multi vigilance database.
- Its fully united platform of tools and functionality offers comprehensive and versatile safety data management via a straightforward, intuitive, and user-friendly interface.
- SafetyEasy comes with an inbuilt query and reporting functionality.
- It provides validated outputs designed for expedited and signal detection, case management, periodic reports.
- The system is presented as a cloud-based software-as-a-service (SaaS) solution, regularly updated to meet current regulatory standards and industry specifications.
- Defining features for AB Cube SafetyEasy are it’s easy to use integrated functionality, user interface, and ease of data movement both into and out of the database.
|
| Clinevo Safety | - Clinevo Safety is currently used by 100+ end clients and is being used to process 100k cases per year.
- It is an all-in-one system that provides PV Intake, Case Processing, AI, Analytics, Submissions / inbuilt AS2 Gateway, Signal Management and Safety Analytics capabilities under one platform.
- Clinevo Pharmacovigilance database / Drug Safety Database includes Case processing, , PV Intake,Submissions, AI & Analytics, and Safety signals
- It is database is built on a simplified technology stack which provides a lot of configurations and less customizations
- It is the best drug safety database /Pharmacovigilance database which provides end user alerts for cases nearing due dates
- It consists of easily configurable dynamic workflows for expedited case processing
- It provides powerful and actionable insights
- It is a user-friendly web application which can be accessed with basic internet / intranet using IE, Chrome and Firefox browsers
- 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 Softwares 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 Sollers website.
Want to explore a career in Drug Safety and Pharmacovigilance? Join our certification or master’s program in the Pharmacovigilance program and kick-start your career in Pharmacovigilance and get experience working in the Argus Safety database.
