Medical monitoring

According to the International Council for Harmonisation – Good Clinical Practice (ICH-GCP), the Sponsor and the contract research organization “should designate appropriately qualified medical personnel who will be readily available to advise on trial-related medical questions or problems.”

Our project team consists of highly qualified medical monitors with extensive experience in clinical research in a wide range of therapeutic areas.

Medical monitoring is carried out in accordance with the Medical Monitoring Plan which is developed individually for each project. The Plan describes and specifies all the required activities to be performed during a clinical study: the procedure for evaluating information about the investigational product safety, the timelines for the review and reporting of serious adverse events (SAE) and serious adverse reactions (SAR), the procedure for evaluating whether the patients meet the inclusion criteria, the criteria for early subject withdrawal, the procedure for reviewing safety listings and medical data, and other clinical aspects of the project.

The medical monitor provides data review from a medical perspective for consistency and integrity, to ensure that medical records and case report forms (CFRs) are completed in strict accordance with the approved study protocol, applicable standard operating procedures (SOPs), current legislation and the principles of Good Clinical Practice (International Council for Harmonisation – Good Clinical Practice; ICH-GCP). The medical monitor works in close collaboration with clinical research associates to ensure that information regarding the safety of the medicinal products is received from investigators and reported to the Sponsor and/or regulatory authorities in a timely manner. The medical monitor provides advisory support to investigators and project team throughout the study, provides training to the project team on the study therapeutic area, participates in preparing reports on unexpected serious adverse reactions and the final study report.

If necessary, an Independent Data and Safety Monitoring Committee is established in the study project management structure, which periodically evaluates the interim data of the ongoing trial and recommends whether to continue a trial or make amendments in the project documents.