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To demonstrate the efficacy and safety of medical devices, systematic monitoring is essential. In particular during the approval process or when conducting clinical trials, the structured and regular review of the processes is necessary to comply with quality standards and regulatory compliance.

In general, the study monitor can perform or assist with many tasks in a clinical trial. Besides the monitoring of clinical trials (e.g. adherence to the protocol) and the communication between the sponsor and the clinical investigator, the continuous (before, during and after the trial) data review (all data has been recorded correctly and completely) is also part of the main tasks of the monitor. For example, the comparison of the case report forms with the original results can reveal potential errors in data entry or digitization (e.g. wrong or missing entries) at an early stage and hence prevent errors in subsequent data analysis or statistical evaluation.  By reporting errors to the clinical examiner, additional sources for errors or inconsistencies in the process can be identified early and subsequently be corrected in order to substantially improve the quality of the study. In addition, the legally required monitoring based on standard operation procedures (SOPs) also leads to potential sources of error being structurally identified and prevented.

CCMD would like to support you in monitoring your clinical trial or in complying with all relevant quality standards. Our monitors are happy to act as a link between the sponsor and the clinical investigator, or help you to plan and maintain timelines more efficiently. They also support you in monitoring the compliance with data protection requirements as well as in settling all appointments with governmental authorities. Our quality management and regular training ensure that our monitors always possess all legally required qualifications for supervising a clinical trial in the best possible and most competent way.In addition to the monitoring, we will gladly provide you with project managers who will accompany and support you from planning to publication in all study-related matters to ensure successful, cost-effective and time-efficient clinical trials.

In the field of monitoring our service includes:

  • Trial logistics and fulfilment of timelines and legal requirements in accordance with MPG and ISO 14155
  • Development and preparation of trial documents and auxiliary materials
  • Selection of qualified study sites/clinical investigators
  • Submission to national authorities and ethics committees
  • SOP-based monitoring (i.e. monitoring plan, visit plan) by experienced, highly motivated and socially competent monitors
  • Preparation of monitoring reports and follow-up letters