« ADAPTATIVE » approach to focus on hazardous spots
For many years, ICTA has been practising a non-formalized "adaptive monitoring" ; According to the nature of the clinical project, its complexity and the type of investigators involved, ICTA has been performing an in-depth risk analysis to draw up a realistic monitoring plan and to adapt optimally the frequency of monitoring visits, their triggering, the percentage of Source Data Verification (SDV) and the number and type of monitoring visits (on-site or remote).
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And with the view to managing better the potential risks, our project managers assess every month the centres needs and organize, or even modulate when necessary, the visits of the CRAs to concentrate on the more sensitive centres, according to predefined factors. This assessment takes into account the whole of the information shared in real time on the ICTA’s CTMS via its i-SIT platform, and allows the project team to have a real-time monitoring of the centres and of the patient data and therefore crossover markers of quality between monitoring activities and data management.
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This approach, in line with the recent guidelines of the "Risk-based monitoring guidance" published in August 2013 by the FDA, is based on our philosophy of risk management and aims to identify as soon as possible the major risks and critical data.
To do this, we adapt our monitoring guidelines to each project, in adequacy with the critical parameters of the study, the early-warning signals, the specificities of monitoring safety to ensure, etc... and train our Clinical Research Assistants (CRAs) for each new study to on-site/off-site monitoring activities, to follow the corrective actions put in place, and in a general way to prevent problems in the centre by providing all the necessary support. This last aspect is also facilitated by the geographical location of our monitors distributed on the whole of the European territory, and mainly in the outskirts of major cities.