Data Management and Databases Integration
Our data-management services ranges from individual study database conception and data-management to the pooling and integration of multiple studies databases from a whole development program. Such integrated databases allow implementation of integrated efficacy and safety analyses and to the production of ready for submission data packages.
Over the years our teams have accumulated extensive experience from phases I to IV, respecting the quality demanded by pre-marketing development and the industry standards (CDISC). We put strong emphasis on streamlining the continuity of data throughout the dossier (i.e. coherence between results in individual reports and summaries or meta-analyses).
We provide the following services:
- Electronic Data Capture (EDC, eCRF)
- Database conception
- Trial Database set-up
- Database conversion
- (e)CRF design
- Coding and validation
- Double data-entry
- Interactive screen controls for Remote Data Entry
- Validation plan
- Edit-checks programming
- Query generation and follow-up
- Automatic status reports
- Data management manual
- CRTs, CRFs Patient Profile
- Audits
- Datapool conception and implementation
- Archiving using FDA recommendations and CDISC
How can we help?
Contact our team of experts for more information.