ADN built, as the years and the projects go by, a team of professionals dedicated to Pharmacovigilance
Our Business Experts
Our System Experts
Help to the choice of systems
Risk Analysis - processing and functional
Validation of the computerized systems used in PV
Migration of data and version upgrades
Data reconciliation
Implementation and qualification of detection Tools
Our Experts in E2B Transmission
Transfer and electronic exchanges.
Validation of transmission systems.
Preparation of transmission tests with the various agencies.
Pharmacovigilance audits
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Risk Management:
- ADN assists you in the management of the Risk analysis related to the system to be used.
- ADN supports you in the Management and preparation of the tests allowing the validation of the system and the reduction of the risks related to its use.
Requirements Management:
- System expertise: knowledge of the tools used in Pharmacovigilance:
- Argus
- Clintrace
- ARISg
- ES/1 - Safety Manager
- AgXchange
- Assistance in the choice of the system to be used according to your company organisation and to your requirements
- Assistance in the choice of the reporting tools
- Collection of the needs allowing the creation of the requirement documents (GAMP 5)
Regulatory Management:
- Regulatory Expertise related to pharmacovigilance (ICH E2B, Volume 9)
- Regulatory Expertise related to the validation of computerized systems (21 CFR Part 11, GAMP 5)
- Management of standard operating procedures and instructions allowing the use of a new system/tool and its insertion in your company processes
- Management of the documentation archiving
- Management of Audits: Assistance in the preparation of audits, Responses to audit requests, documentation search.
