- We know the legal requirements for monitoring in academic research and which measures protect the security and rights of participants and ensure the correctness and credibility of the data collected.
- We have years of experience in making monitoring efficient. In doing so, we adhere to two principles which we continuously help to improve:
Risk-based monitoring is the pragmatic counterpart to 100% complete monitoring.
The monitoring activities are focused on those aspects of a study that have an impact on patient safety or the study process. These are influenced, for example, by the study design, the intervention tested or the examination methods.
Centralized monitoring is supported by data management experts.
The focus is on the process of data collection, which has an impact on the safety of study participants or the course of the study, and which can be checked in real time using data collection tools.
In the planning phase, we check which risk class your study belongs to and work with you to determine the appropriate scope for the monitoring activities. The experience of your study team plays an important role in this decision. The procedure and the detailed contents of the monitoring are finally recorded in a monitoring plan.
In the setup phase of your study the initiation of the study center takes place. The study team and the responsible monitor discuss the planned course of the study and confirm that all preparations for a successful study start have been made. Care is taken to ensure that
- the study documentation and materials are complete,
- all necessary approvals by ethics committees and/or competent authorities are available,
- the planned data documentation and communication channels are clarified, and
- all parties involved are trained.
The study center is then ready to start recruiting study participants.
While the study is ongoing, routine visits as defined in the monitoring plan take place to check whether the planned course of the study can be adhered to and how the documentation and reporting is carried out in practice. The responsible monitor records the results of each visit in a report and provides advice and coordination in case of questions and difficulties. He or she is in close contact with other parties involved, such as data managers or statisticians. If necessary, other departments involved, such as the pharmacy, can also be monitored.
With the close-out visit and the resulting close-out report, the monitor confirms the formal end of the study. Together with the study team, all study documents are completed, all study medication is collected and any outstanding reports are finalised.
For all questions concerning your clinical trial, we offer project-related consulting services tailored to your needs. We consult experts from the individual services and provide suggestions for further action.
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If you have any questions regarding your clinical trial, please contact us by phone:
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