©-2007-AMITIS-Tous droits réservés
This service provides all or part of the management of clinical trial data (Phases I to IV and related phases), from the elaboration of CRF to the integrated report.
The data management and statistical tasks are performed by an experienced team, accustomed to rigorous working practices, and who are capable of integrating quickly and effectively into the project team.
They guarantee a high level of quality and can provide precise and clear documentation at all stages of the process.
- Data Management Manual
- Data tables to Sponsor’s standards
- Proposal of proven standard tables
- Conformity with international standards
- Protocol data entry screens using Clintrial™
- Validation Plan for the Data Base
- Programming of data consistency checks
- Tracking of pages and appendices
- Independent double data entry
- Sending of e-DCFs or (self-duplicating)paper DCFs
- Ongoing quality controls
- Ongoing computer assisted codification
- Listing of data and ad hoc safety reports
- Blind-review, definition of analysis populations
- Data Management Report
- Transfer of data onto CD-Rom