For decades, there has been a requirement to record, analyse, and report safety data to health authorities. With the recent improvements and shifts in approach, such as the updated GCP guidelines, parties involved in clinical research and development are looking at their systems and support network with fresh eyes.
Clinical trial sponsors and marketing authorisation holders (MAHs) often outsource management of safety data to a CRO or specialised pharmacovigilance (PV) service provider. To meet global regulatory requirements such as ICH E2B(R3), FDA 21 CFR Part 11, and EU GMP Annex 11 and broader EMA guidance (including GVP), these PV service providers must be equipped with a safety database to monitor and report safety findings in compliance with each authority’s guidelines.
As case volumes rise and data comes in from multiple studies and/or partners, a centralised safety database helps teams avoid fragmented records and support consistent oversight and reporting.
What is a Safety Database?
A safety database is a system which records and stores adverse event related data of a product from sources such as clinical trials and post-marketing surveillance. In practice, a centralised safety database acts a single repository for safety reports from clinical trials, healthcare professionals, literature, and patient submissions, so teams can review and report from one controlled system. It helps sponsors and MAHs make informed decisions and report the safety findings to the regulatory authorities.
Key Functions of a Safety Database
Collection and Processing of Safety Data
Adverse event reports are collected and recorded into the safety database. Intake can be streamlined to reduce manual steps, for example by receiving reports through web portals, safety mailboxes, E2B(R3) XML feeds and gateways, or integrations/APIs with clinical and safety systems. The data is then processed in the database to obtain a clearer picture from a medical standpoint. With the help of the safety database, pharmacovigilance teams can identify duplicate reports, checks for missing data, performs coding of events and drugs using tools like MedDRA and WHODrug to keep records accurate.
Regulatory Reporting
Adverse events can be reported to health regulatory authorities via standardised reports generated by safety databases. Individual adverse event reports are generated from the safety database in form of a CIOMS or MedWatch form, or E2B-compliant xml, and submitted to regulatory authorities.
Early Signal Detection
As the safety database can hold records of all adverse events related to a drug, safety signals could be detected early. In practice, teams define how alerts are triaged and escalated so signal management stays consistent across studies and sources.
Supports Aggregate Reporting
Safety databases generate safety listings to be incorporated in aggregate reports such as PSUR/DSURs.
Provide Audit Trails
Safety databases track every change with role-based access controls for audit and monitoring purposes.
Benefits of Centralisation
Some key benefits of utilising a single centralised safety database across all studies, sources and products are:
Holistic Safety Monitoring
An integrated safety database provides a holistic view of safety data, combining information from different studies and sources. This comprehensive approach helps rapid identification and reporting of potential safety concerns more accurately. It also supports a ‘single source of truth’ approach, where teams work from consistent, current case data across programmes.
Accelerate Operations and Ensure Data Quality
An integrated safety database cuts manual collation steps and speed up product-focussed data collation (e.g. for DSURs). Data from all programmes is captured consistently across data entry and narrative generation, in alignment with established Sponsor/MAH preferences.
Enhanced Signal Detection and Risk Management
Unlike fragmented safety databases, the centralised safety database provides prompt signal detection and risk management.
Better Regulatory Compliance
Centralised safety database makes regulatory compliance easier for safety monitoring and reporting as the required data is available at a single repository. A controlled audit trail and consistent process can also support audit and inspection readiness.
Cost Effective
With all safety data stored in a single database, there is no need for duplicate data entry or the maintenance of multiple systems. This eliminates the cost associated with managing separate databases and reduces the risk of data inconsistencies.
Centralisation also works best when teams plan governance, integration, and training upfront, so the database supports day-to-day delivery as well as reporting.
Implementation Models & Considerations
In-House Deployment
Some safety databases are built and maintained internally by the Sponsor/MAH for maximum control. These databases can be configured based on the specific requirements of the project. This approach requires in-house specialists and investment in computer systems validation and the related quality management system.
Outsource to Specialists
Safety database setup and maintenance can be outsourced to specialists to for rapid setup and expert support.
Hybrid Approach
The database is configured to combine internal and external resources for flexibility.
Plan Change Management
Update SOPs, train users, and select vendors based on integration and support capabilities. When selecting a model or vendor, teams typically consider interoperability (for example E2B(R3) import/export, validation expectations under applicable regulations, service support, and how they will manage safety data migration from any legacy systems.
Conclusion
Safety databases are fundamental to ensuring drug safety and protecting public health. By consolidating safety data from various sources, these databases draw a comprehensive picture of the safety profile of medicinal products and help regulatory bodies take timely action to mitigate risks associated with pharmaceutical products. A centralised safety database also supports regulatory readiness by enabling consistent reporting, traceable changes, and efficient access to current safety information.
About QVigilance
We are a specialised pharmacovigilance service provider, offering comprehensive pharmacovigilance services to sponsors of clinical trials and manufacturers of authorised medicinal products. QVigilance is adept in supporting customers establishing a compliant pharmacovigilance system to support our customers’ products and safeguard their patients.
FAQs
What is a safety database?
A safety database is a controlled system used to capture, manage, and report safety information for a medicinal product. It supports co9llection of Individual Case Study Reports (ICSRs), including adverse events and adverse drug reactions (ADRs), and maintains audit trails and access controls so teams can review and submit safety information in line with applicable requirements.
What is the difference between a clinical database and a safety database?
A clinical database (often an electronic data capture system) stores protocol-defined trial data such as assessments, lab results, and outcomes for stud-based analysis. A safety database is built for pharmacovigilance case management. It is product-focused, capturing and processing safety reports from trials and post-marketing sources, and enables regulatory reporting and signal management workflows.
What is the best database for pharmacovigilance?
There isn’t a single ‘best’ database for every organisation. The right choice depends on your case volumes, reporting footprint, and operating model. However, teams typically look for support for E2B(R3) reporting, controlled audit trails and access, validated operation under applicable requirements (for example Part 11 and Annex 11 expectations), efficient case processing (duplicate checks, coding, follow-up), aggregate reporting functionality (PSUR/DSUR listings), integrations with other systems, and a practical approach to migration, training, and ongoing support.