ADN consultants have built over the years, and through the several projects, expertise dedicated to clinical trials
Our Business Experts
- Clinical Data Management:
- CRF & eCRF Management
- Data entry, Coding, Discrepancies management
- Reports management
Our System Experts
- Assistance in the system selection
- Process and functional risk analysis
- Validation of computerized systems EDC and eCRF
- Migration of data and version upgrade
- Data reconciliation
- Query management
Our Quality Experts
- Management and preparation of standard operating procedures and instructions
- Management of the system validation
- Systems Audit
[Translate to English:] Requirements: Gestion des besoins
- Expertise Système: Connaissance des outils utilisés dans la gestion des données Cliniques (Clinical Data Management):
- Oracle Clinical / Oracle Clinical Remote Data Capture (OC RDC)
- Clintrial / Inform
- Capture System
- SAS
- Symetric
- ECI
- Impact
- Aide au choix du système à utiliser en fonction de l’organisation de votre société et des besoins exprimés
- Aide au choix des outils de reporting
- Collecte des besoins permettant la rédaction des cahiers de charges (GAMP 5)
Risks: Gestion des risques
- ADN vous accompagne pour la réalisation de l’Analyse des risques associés à l’utilisation d’un système
- ADN vous aide à gérer, à préparer les tests permettant la validation du système et à la réduction des risques associés à son utilisation
Regulation: Gestion Réglementaire
- Expertise réglementaire relative à la gestion des données cliniques (ICH E6, Volume 10)
- Expertise réglementaire relative à la validation des systèmes informatisés (21 CFR Part 11, GAMP 5)
- Préparation des procédures et instructions permettant l’utilisation de l’outil et son intégration au sein des process de votre entreprise
- Gestion de l’archivage de la documentation
- Participation aux Audits, préparation des documents de réponse, recherche documentaire
Requirements Management:
- System expertise: knowledge of the tools used in the Clinical Data Management:
- Oracle Clinical / Oracle Clinical Remote Data Capture (OC RDC)
- Clintrial / Inform
- Capture System
- SAS
- Symetric
- ECI
- Impact
- 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)
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.
Regulatory Management:
- Regulatory Expertise related to the clinical data management (ICH E6, Volume 10)
- 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.
