ITREAS provides medical monitoring services to (co-)monitor compliance by the sites with pre-defined protocol procedures and requirements. We assist with (the design of processes) for the review of (blinded) patient and site data such as (S)AEs, study medication administration and compliance, concomitant medication and laboratory results to safeguard the patients’ safety throughout the study and to ensure that no events are missed. We can also assist with the review of protocol deviations and site specific trends that allows study management to take informed decisions with regard to site performance.
Our processes “unburden” the investigators while imbedded in a high quality and efficient framework.
We can provide 24/7 helpline support for sites that participate in a clinical trial as part of medical monitoring or as a separate service. This 24/7 helpline support can be reached per email and toll-free phone. The ITREAS medical helpline is a resource for investigators and study coordinators seeking medical or scientific advice regarding the conduct of a study and study specific medical management of patients that are included in a study (e.g., questions regarding study procedures, the use of concomitant medication and reporting of events). The medical helpline for each study is staffed around-the-clock by ITREAS affiliated physicians with significant experience in the therapeutic area of a study and who are all extensively trained on the protocol and relevant study processes and procedures.