Clinical Data Management
This unit efficiently manages all aspects of data management, in accordance with the Data Management Plan, ensuring accurate data and timely completion of the clinical database. Our consultants have had many years of experience working with all stages of data management, electronic data capture and web-based trials. TFS clinical databases and software are validated in compliance with European, ICH and FDA standards. The latest applicable versions of SAS® programs are always used in the clinical trial.
Services provided:
- CRF development (including diaries, manuals, Quality of Life assessment forms)
- Data management project set-up (Data Management Plan, Data Validation Plan, Data Entry Guidelines)
- Database set-up and validation
- Programming of data validation checks
- Data entry, verification and validation
- Coding of adverse event, concomitant medication etc in dictionary of your choice, including MedDRA as standard
- In-house data management personnel on short-term contracts
- Tools for three principles of data capture: Traditional Data Entry, DataFax and Remote Data Entry (ClinEntry®)
- Automatically updated status reports through CliniGate®
