The team uses cutting-edge technology in electronic data collection and is more competitive in undertaking projects. The integration of these processes with Eurotrials’ data management system, which has been validated and is in strict compliance with FDA 21 CFR part 11, is an essential asset.
The new data-collection technologies include:
- Web portals (to manage each project’s data);
- ePRO (electronic Patient Reported Outcomes, such as digital patient diaries by mobile phone or PDA, diagnostic and measuring devices with electronic data collection);
- IVRS (interactive voice response system, by telephone);
- IWRS (interactive web response system, via the web).
Preparation of data management plan
Preparation of annotated CRF, database dictionary and manual
Preparation of data validation plan
Design, programming and validation of database
Data entry
Detection of inconsistencies: emission, tracking, receipt and entry of queries
Final quality control for database lock
Codification of adverse events (MedDRA) and medication (ATC/DDD code)
Export of information to datasets in SAS
Preparation of tables and listings
Project management
Preparation of data management report