• 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

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.

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Monitoring plan

We check which risk class your study belongs to and help 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.

Study initiation

We discuss discuss the planned course of the study with the team of each study centre and confirm that all preparations for a successful study start have been made. We take care 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 centre is then ready to start recruiting study participants.

Monitoring visits

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. We document the results of each visit in a report and provide advice and coordination in case of questions and difficulties. We are in close contact with all parties involved, such as data managers or statisticians. If necessary, other departments involved, such as the pharmacy, can also be monitored.

Close-out visit and final report

With the close-out visit and the resulting close-out report, we confirm 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.

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