Drug Safety Database.
What is a Drug Safety Database?
A Drug Safety Database is a key part of any pharmacovigilance system, holding MeDRA coded safety data from various sources including clinical and post-marketing SAEs, ICSRs, Aggregate Reports, and Pregnancy Reports.
Current Drug Safety Databases must meet key safety standards, typically ICH E2B (R3), which define the data structure within the records for seamless import/export of files between systems.
Drug Safety Databases can perform many automated and real-time functions in the processing and analysis of safety data including:
- Automated coding.
- Automated validity and duplicate checking.
- Automated case tracking and follow-up.
- Automated submission.
- Real-time reporting, dashboards and Benefit-Risk analysis.
How we ensure your drug safety data, stays safe.
Our in-house IT team offers a complete drug safety database management service including data migration, configuration, ongoing maintenance, using Veeva Vault Safety – a highly configurable and flexible validated cloud-based safety database developed and provided by Veeva Systems.
Our configuration and set-up process follows an approved procedure to minimize human error in five main data sets: Sponsor, Product, Study, Users, and Receivers/Contacts.
If you wish to continue to use your own drug 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:
- Secure, compliant, and validated in accordance with FDA 21 CFR Part 11 Electronic Records, Electronic Signatures, and EudraLex Annex 11: Computerized Systems regulations.
- Full design and alignment with ICH E2B (R3) structure.
- Continuously updated to meet the latest regulatory requirements.
- Direct gateway connections for EMA submissions, and later FDA and MHRA.
- Powerful real-time reporting and dashboards.
- Easy access to your data.
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.