Risk-based Monitoring & Study Management

Monitoring activities are the main cost driver in clinical studies. Research has shown that more than 50% of clinical trial costs are spent on monitoring activities. Further, monitoring activities have also been shown not to be as effective as they should be.


One reason is the variation in the performance of the individuals involved in these activities regardless of whether they are contracted or in-house individuals. It also depends very much on the willingness of co-operation by the investigators and their teams. Another reason is that especially in industry-sponsored trials, monitoring has shifted over the past decade from a systematic approach of site advice and oversight to a rather tactical methodology with a focus on Source Data Verification (SDV). A centralised or data-driven methodology for monitoring requires objective criteria when an intervention is warranted. In the traditional approach to monitoring such criteria were the routine visits at predetermined intervals, number of patients enrolled, etc. whereas in a data-driven approach dynamic criteria must be developed that are transparent and meaningful in terms of patient safety and data integrity. Methodologies such as Multi Criteria Decision Analysis (MCDA) can be valuable tools.


How can Widler & Schiemann assist you with your Monitoring and Study Management projects?
By using QbD and QRM methodologies, we are in a unique position to help you design your new approach to a targeted and centralised monitoring approach. Monitoring activities should focus on the areas that matter most. Therefore it is essential that a process is put in place to identify these. Key to this are the data that starts to flow from the day the first patient is entered into the trial, and with current Electronic Data Capture (EDC) technology, it is becoming more and more frequent that this wealth of data are made available centrally in real time from investigational sites.

Widler & Schiemann will work with your experts and process owners to identify workflows, processes and systems that need to be adapted to support a revised monitoring approach so monitoring is more targeted and focused. The aim of this analysis is to make trial oversight and monitoring less costly while driving up quality and patient protection in your clinical trials. A first step is usually to identify the metrics and define how metrics get applied to produce a priority list of sites that should receive a tailored monitoring contact or visit. Or, if you have already thought about a thorough revision of your monitoring approach, Widler & Schiemann will support your teams to fine tune and finalise it. In addition, we will work with you to initiate and support the change management activities required to deploy this new approach. Our experience shows that the paradigm shift needed to move to a targeted and centralised monitoring approach requires a carefully designed change management program that should touch - at least to some degree - the entire organisation.

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