Case management in clinical trials refers to the individual coordination and monitoring of a participant’s disease or trial course. It ensures that all protocol steps are followed and that the patient receives the necessary support to remain in the trial (retention). In the context of pharmacovigilance, case management encompasses the systematic handling of individual safety cases (ICSR) from capture through to reporting.
Effective case management is essential to minimise the rate of premature study discontinuations. In complex trials, such as in oncology or rare diseases, the case manager acts as a link between patient, investigational site and sponsor. They ensure that logistical hurdles are removed and that participant safety is maintained through continuous monitoring.
Technologically, case management is today supported by integrated systems that centralise patient data, appointments and safety reports. For CROs, this is a core competency in site management, ensuring the quality of data collection at the patient level and guaranteeing compliance with regulatory deadlines for case handling in pharmacovigilance (GVP).
Mediconomics – für individuelle CRO-Lösungen.
