Safety Database.
How we ensure your safety data, stays safe.
Our in-house pharmacovigilance IT team offers a complete safety database management service including rapid configuration and onboarding, ongoing maintenance, and data migration activities, using Veeva Vault Safety – a highly configurable and flexible validated cloud-based safety database developed by Veeva Systems.
Our rapid onboarding process follows an approved procedure to minimize human error in four main setup steps: Sponsor, Product, Study and Users.
If you wish to continue to use your own safety database, our IT experts can still support you in many areas including system configuration, validation, maintenance, and data migration.
Where case data migration services are needed, we can provide a full scope service utilizing a project-based approach that follows industry best practices.
Key benefits of using Veeva Vault Safety:
- Continuously updated to the latest regulatory requirements.
- Direct gateway connections for EMA submissions, and later FDA and MHRA.
- Powerful real-time reporting and dashboards.
- ICH E2B (R3) structure alignment.
- Secure, compliant, and validated in accordance with FDA 21 CFR Part 11 Electronic Records, Electronic Signatures, and EudraLex Annex 11: Computerized Systems regulations.