Gateway between study team and sponsor
Monitoring is a quality control tool to ensure the integrity of trial data and the protection of the rights and the well-being of study participants.
The monitor links the study team with the sponsor. Monitors check whether study activities are according to protocol, GCP, SOP and regulatory requirements. Thus deficiencies can be identified and improved. To reach these goals with adequate resource utilization, we adapt monitoring intensity to the estimated risk a study bears. Your specific trial will receive a tailored monitoring approach.
We provide the following services:
- Review of the study protocol with respect to the described monitoring activities
- Preparation of trial specific monitoring plans/manuals
- Monitoring of the conduct of clinical trials (site selection-, initiation- , regular-, and close-out visits), in order to oversee data collection, review source documentation and case report forms, ensure regulatory compliance and resolve data queries.
- Advisory services and training for investigators and study teams on study protocol and study conduct.
Fon +49 221 478-
Dr. rer. nat.
Montada, Angelika Anna Maria