ADN consultants have built over the years, and through the several projects, expertise dedicated to clinical trials
Our Business Experts - Clinical Data Management
- Case Report Form (CRF) & electronic Case Report Form (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 Electronic Data Capture (EDC) and electronic Case Report Form (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
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 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)
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.
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