Clinical Trial Monitoring
Bielderman conducts field monitoring to ensure protocol and regulatory compliance and timely submission of high quality data.
Project Management
Frequent and direct communication is a prerequisite for optimal performance. Therefore an experienced Project Manager is in charge of each international trial and is your primary point of contact throughout the project.
Monitoring
Our monitor/clinical research associate guarantees up to date knowledge of your trial status at each participating hospital. Our monitoring activities consist of:
- Pre-study and initiation visits
- Monitoring visits
- Source Document Verification
- Close-out visits
- Trial document handling
- Reporting of safety information
- Administrative tasks
SAE/AE reporting
Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.
Clinical monitoring
One of the services that distinguish Bielderman from conventional CROs is our clinical monitoring service. We are proud to have experienced technical experts and MDs in different clinical fields who can provide monitoring of clinical procedures so you can verify that your device is used as you intended.