The Clinical Data Management unit efficiently manages all aspects of data handling in accordance with the protocol, the data management plan, efficient data capture, accurate data and timely completion of the clinical database.
TFS has many years of experience working with clinical data management utilizing a broad knowledge of different electronic data capture tools and paper-based trials. TFS clinical databases and software are validated in compliance with European, ICH and FDA standards.
Our Services include:
- Full service data management support
- eCRF and paper design
- Data Management Documentation (DMP, DVP, DMR, etc.)
- Database set-up, Data Entry, Medical Coding, Data Validation and Cleaning
- Reconciliation of lab, ECG, imaging data, etc.
- SAE reconciliation
- Support and training of investigators and monitors
- Data Transfers
- System Validation
- Flexible data capture techniques across major EDC platforms
- Databases are constructed according to CDASH (CDISC)
TFS has clinical data management teams based in the US and Europe offering customers cost effective and flexible EDC technology, including OmniComm and Trial-on-Line