Database Services & Technology Solutions - Overview
In the realm of pharmacovigilance (PV), the use of safety database services and technology is vital to maintain the safety and efficacy of pharmaceutical products. The central repository of ICSR data for the company's medicinal products from all around the globe is a Pharmacovigilance safety database. The reporting of individual and aggregate safety data to authorities and third parties is facilitated by it, as it provides key information in detecting safety signals and continues to determine the risk-benefit profile for the company’s products.
Selecting the Optimal Pharmacovigilance Safety Database
Selecting the appropriate pharmacovigilance safety database involves considerations beyond regulatory compliance, including:
- Costs: Evaluate implementation and maintenance costs, including hosting model availability such as internal infrastructure, third-party hosting, or vendor 'cloud' options.
- Prior Experience: Consider past experiences, both positive and negative, with different database solutions.
- Compatibility and Interoperability: Assess compatibility and interoperability with other systems within the company's infrastructure.
Implementation costs, including resources and effort required, should not be underestimated. Robust and risk-based computer systems validation measures are necessary to ensure the system is fit for purpose and meets regulatory and business requirements.
Commercial Off-the-Shelf Solutions
There are several commercial off-the-shelf pharmacovigilance databases available as they have significant cost, resource, and time benefits of developing in-house solutions. Many companies in the industry know what these established systems are and have 'tried and tested' them.
While these databases claim compliance with the latest regulatory requirements such as ISO ICSR ICH-E2B submission, careful setup, validation, and management are essential for true compliance. The complexity of these systems, including customizable workflows and report parameters, may present challenges in validation, maintenance, and usability.
Choosing the appropriate pharmacovigilance safety database is vital to meet regulatory compliance, data integrity, and patient safety. Pharmacovigilance safety databases are supported comprehensively by Freyr from the choice, through implementation and management to informed decisions and optimum health care outcomes from pharmaceutical companies.
Database Services & Technology Solutions
- Timely signal detection of adverse events via data collection from various sources ensuring coverage of safety-related data
- Harmonised case management processes for data entry, coding, classification, and workflow management
- Regulatory Compliance and Reporting to facilitate the production of regulatory reports and compliance with all global regulations.
- Quality Management and Auditing to ensure data integrity and traceability as well as to the GVP and quality standards.
- Interoperability and Integration to enable ease of data exchange and interoperability between the components of the PV ecosystem.
- User Interface and Accessibility to provide usability through user-friendly interfaces and customizable reporting functionalities for the professional PVs.
- Advanced Analytics and AI improve detection of signals, automate case processing, and ingest knowledge from the noisy corner of unstructured data sources.
- Safeguarding pharmacovigilance safety databases implementation and management.
- Solutions that optimize PV processes and improve data quality and efforts.
- Regulatory compliance with global regulatory standards, GVP, and regional reporting requirements reduces regulatory risk and data integrity.
