Clinical Trial Data Management for Medical Devices
The success of any clinical study highly depends on the accuracy of the data collected. The Emergo clinical team and data manager will work with you to ensure data is collected, entered, verified, and reported according to the protocol and other requirements. Our goal is to provide you with the highest quality reliable data for analysis, following ISO 14155, ICH-GCP (Good Clinical Practices) and, where applicable, the European Clinical Trial Directive (2001/20/EC).
Our data management services include, but are not limited to:
- Development of the Case Report Forms (CRFs)
- Generation of Data Management and Data Validation Plan
- eCRF Training
- Database Management
- Data review
- Data processing for reporting
- Data exports / transfers / digest
Emergo can support clinical data management on several platforms. Please contact us for additional information on our clinical trial data management services.