This blog uncovers:
- The definition of a safety database
- A list of databases that may not be widely known
- The components and important capabilities to consider when selecting a database.
Table of Contents:
- What are safety database?
- Purpose of the clinical (PhV) database
- Choosing the right database
- A comprehensive list of database
- Other honorable mentions
- Conclusion
- References
What are safety database?
Safety database(s) refer to software systems that collect and store clinical content, such as questions, diagnoses, and management advice. The content includes various elements such as prompts, weightings, suggested answers, and methodologies.
The data may be drawn from one institution, multiple clinical centres, or population-based observations.
Purpose of the clinical (PhV) database
Safety databases are electronic filling systems designed to capture patient data across a range of clinical and administrative settings. These databases are used for research purposes, such as assessing healthcare quality, evaluating diagnosis and treatment, analyzing health policy, and investigating adverse drug reactions.
It is a central repository of collected details of Adverse events from all global sources.
Market demand
The demand for pharmacovigilance services is increasing rapidly as the number of adverse events being reported continues to grow. As a result, the market for pharmacovigilance is expanding significantly and in ways that were previously unforeseen.
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Choosing the right database
There are some important features needs to be considered when you or your organisation choose.
- ISO ICSR ICH-E2B submission (Learn more…)
- Compliance
- Cost of implementation and maintenance
- Hosting (Learn more…)
- Compatibility
- Regulatory requirements
- User-friendly interface
- Security
- Integration
- Functionality
📢 Since we are exploring the pharmacovigilance database, you should definitely check out the history and evolution of the pharmacovigilance database.
For Good Pharmacovigilance Practice, Safety database should be complaint with 21 CFR part 11. All safety decisions about certain drugs are taken based on the information available in the database.
List of database
The below are the most familiar databases that are used in pharmacovigilance.
1. Argus safety database
Oracle Argus is a widely-used, market-leading pharmacovigilance database developed by Oracle, a company with a history of successful projects. Argus safety database is the leading product in Oracle’s portfolio, providing all the necessary features for pharmacovigilance submissions to regulatory bodies.
Some main features are:
- Global case processing
- Signal detection
- Electronic case intake (Learn more…)
- Electronic submission
- E2b reporting (Learn more…)
- Hold large amount of cases
You can find all the related information down here.
2. Aris Global
Aris Global is the second most familiar database, otherwise known popularly as Aris Global’s LifeSphere Safety. It is long and well established in industry. ArisGlobal’s intuitive, intelligent, unified technology empowers companies to safely and effectively accelerate research and development.
An award-winning, market-leading LifeSphere® platform enables teams to accelerate product development, stay compliant, and streamline collaboration–so your innovations can positively impact lives worldwide.
3. Veeva safety
Veeva Vault Safety is part of the Veeva Vault Development cloud. It also a popular database used by several companies. It mainly focus on small scale companies. In coming years Veeva vault would be one of leading database. They are more concentrate on developing for competition with other leaders.
There are numerous pharmacovigilance databases available, allowing you to choose the one that best fits your needs. In this article, we will provide a detailed explanation of three databases that are highly regarded in the market. However, it’s important to note that other options may be available and suitable based on your specific requirements.
4. Flex Database
Flex Databases Pharmacovigilance is a comprehensive drug safety database that ensures robust and compliant management of pharmacovigilance activities, covering both clinical trials and the post-approval stage. It offers an end-to-end process for collecting, triaging, evaluating, and submitting safety data, all in one centralized system.
Considered one of the upcoming leading databases in the field, it provides excellent value for money and boasts a user-friendly interface with intuitive features.
The database supports both automated and manual import/export functions, accommodating E2B R3 and XML formats. However, data export options are limited to Excel, Word, XML, and PDF.
Key features of Flex Databases Pharmacovigilance include:
- Configurable automatic duplicate search based on specified criteria.
- Automated validity checks to ensure data accuracy and completeness.
- Multi-language capabilities for accommodating diverse user needs.
- Dedicated tracking of pregnancy and literature cases, facilitating efficient monitoring and management.
5. AB-cube easy safety
Founded in France in 2006, AB Cube Safety Easy has emerged as a trailblazer in the international healthcare sector by offering pioneering SaaS solutions for managing adverse events. Based on the information available in their website it is the first cloud-based database in the industry.
It primarily works on reporting Adverse events from multiple sectors as Multivigilance are Pharmacovigilance, Medical Device Vigilance, Nutrivigilance and Cosmetovigilance. For further exploration and in-depth information, you can visit the link provided below.
6. Clinevo safety
Clinevo Safety is a tech company that focuses on creating and applying strong technology solutions for research and development in the life sciences, assist pharmaceutical companies, biotech firms, and contract research organizations (CROs) in cutting down on time and costs associated with clinical trials.
Clinevo Safety Solutions offers extensive support in the pharmaceutical industry, covering areas like clinical trials, pharmacovigilance, and quality management..
They follow the GxP Guidelines, ensuring compliance and quality standards. With offices in the USA, UK, EU, and India, they provide comprehensive pharmacovigilance solutions that include signal detection and handling regulatory data loads like FAERS.
Their services are cloud-based, providing flexibility and accessibility. Key features include support for both R2 and R3, along with an inbuilt AS2 gateway for seamless communication.
Some honorable mentions:
- Vigibase
- Ennov Group – PV works
- Basecon – safetybase interchange
- ClinTrace
- itclinical
- Tepsivo safety database
- Clinskill
- Vigilanz Dynamic Monitoring System
- Mymeds&me
- WebVDME Pharmacovigilance signal detection and signal management software
- Spectra
- repClinical
- Tara PV
- Quanticate
Conclusion
We’ve included everything we know in the list with pharmacovigilance databases, and we’re continually gathering insights from other databases too. We’ll keep updating it regularly.
If you’re aware of any specific database we’ve missed listing here, feel free to mention it. Stay tuned for more updates and keep reading.
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