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.
What our clients say about us.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.