Each clinical study may have a more challenging time when specialized support is needed to solve particular problems. Root cause analysis is a very important step. Having a complicated structured system of study conduct, a third party professional may provide more objective perspective and make it easier to locate the root cause of the problem. Identification of the weaknesses’ source enables the selection of the proper improvement strategy that will implement corrective, preventive or improvement actions in an efficient way.

There are phases of the project when certain departments are more involved. Support may be needed at a specific operational area, management level or even as separate actions to solve the specific problem or provide other expected results.

Full time or part time cooperation is possible with a particular number of hours per week or month as agreed. Moreover, in case of dynamic changes in the project, an even more flexible approach can be selected with the numbers of hours adjusted to the current project needs.

When developing a particular improvement strategy, it is important to adjust to the company processes and follow the client’s standard operating procedures or a specific set of guidelines, depending on the area of a project where support is needed. It is crucial to have a strategy that is feasible.

Nothing will streamline the project better than the truly involved team. The best motivation is personal motivation, as there is always a bigger underlying reason for our actions. Thus, understanding of the practical aspects of CRAs, sites personnel and other clinical trial team members’ work is the first step in the improvement. Pointing out practical benefits for individuals will enable the smooth implementation of the required changes. Very often problems can be solved by responding to a hidden need and it might be simple aspects like communication or the way of performing a particular task. For the above reasons an interim manager should be a clinical trial field expert with coaching skills that will allow to release the hidden potential from the team.

Taking care about the quality of our work from the very beginning, means the understanding of the responsibility for patients’ safety and wellbeing. Additional obvious benefits are quicker, easier and more pleasant work resulting in overall acceleration of the marketing authorization process.