The success of a medical device clinical trial depends highly on the accuracy of the data collected. The Emergo clinical consulting teams working in concert with you, and our biostatistician will ensure that your clinical trial data is collected, entered, cleaned and reported in accordance with the protocol and other requirements. The ultimate goal is to provide you with high quality, reliable data for analysis. We closely follow Good Clinical Practices (GCP) and the European Clinical Trial Directive (2001/20/EC).
Our clinical trial database management services include:
- Database development, entry and processing.
- Specification of data validation rules.
- Training on database entry and maintenance.
- Case Report Form (CRF) design and development.
- Standard checks for data integrity.
- Paper or EDC collection capability.
- Creation of study progress reports.
- Audits of database development in accordance with SOPs.
Clinical trial database development
Regarding the development of the clinical trial database, we can fully assist with this once the Case Report Form has been finalized. Emergo can support clinical data management on several platforms. Your data is stored in accordance with US 21 CFR Part 11 requirements in a highly secure data center. All data is backed up daily and protected by the latest technology against loss, corruption or unauthorized access. Yet, all of your data is fully accessible to you anytime via a password protected, encrypted Web portal.
Please contact us for additional information on our clinical trial data management services.