Services
Do you need comprehensive end-to-end pharmacovigilance services to meet the demands of the worldwide regulatory authorities?
- Our global drug safety database helps you to track, process and report adverse events in your client specific database instance.
- We can support you in building your own in-house pharmacovigilance program (PV database implementation and validation).
- For established PV departments, our specialized IT communication and access support has acquired the expertise and tools necessary to meet new challenges in enabling secure communication and ensuring secure remote access to your safety database
Global drug safety database
Our global drug safety database Argus Safety provides you with a tailor-made and cost-effective drug safety solution for small- and mid-size pharmaceutical companies.
- Complete PV software system
- Web-based tool to capture, manage, evaluate and report ICSRs according to regulations and internal needs; custom made workflow and user groups
- Validated and 21 CFR part 11-compliant environment
- Highest security standards
- Global regulatory reporting pre- and post marketing (CIOMS I form, MedWatch form, etc.)
- Electronic safety reporting according to E2B standard (XML message)
- E2B interchange module (from 2011 onwards)
- Validated reports for data retrieval and compliance report
- Regular MedDRA updates
- Extensive quality control built-in (field validation, pre-save and post-save checks)
- Client-specific database instances
PV database implementation and validation support
- Validation plan
- User requirements
- Configuration documentation
- User acceptance tests
- User manuals
- Working procedures
- User train
Communication and access support
- Installation of secure e-mail connections
- Installation of remote access to your database
- Installation of video- or teleconferences
Dr. Susanne Kaiser
Director Pharmacovigilance
+49 6196 7709-292
