The knowledge previously described should be in any organization that conducts global clinical trials. For organizations beginning to implement such concepts, the process of structuring knowledge can be done step-by-step as the organization gains experience in conducting clinical trials. In either case, the project team must involve experts experienced in global clinical development programs. It is critical to capture this knowledge and implement it into the projects so that the knowledge remains in the organization.

The planning of a global clinical trial should be done on a study, country, and site basis to increase the accuracy of planning. The project plan template should be developed by senior staff with input from the different departments, as a successful plan requires a high level of detail that can only be completed by people who know the best possible strategies to achieve study goals in the shortest period of time. Using this template, the project team does not need to go through the planning process each time there is a new clinical trial.

Planning process

The process described can be understood through an example. If a company wants to organize the planning of the clinical trial start-up process, we may assume that the project starts with country selection and identification of clinical trial sites at the same time the company starts the translation of all essential documents. However, the local Ethics Committee (EC) submissions will not start until the applicable essential study documents are translated for those countries that require document submission in the local languages.

The duration of each activity should be defined based on previous experience doing these activities, internal metrics, and information provided by study sites. At the same time, those tasks linked by dependency (in this case, essential document translation is the predecessor for EC submission) and those to be done in parallel should both be identified (e.g., site identification and essential document translation) in order to get the critical path for any trial. In other words, a planning structure and framework that increases the level of predictability in the conduct of any trial should be provided to the project team.

Based on the above considerations, the process that leads to successful planning is as follows.

Introduce the concept of planning into the organization. Senior management should involve people from all levels of the organization to structure the knowledge so that the project teams can use this approach as a framework for planning the tasks to be performed throughout the duration of the study.

Define the limits of the planning by identifying the main goals. For example, if a company is defining the planning for a trial start-up phase, the main goal is to get all sites up and running.

Define the critical path including the duration of each task. The most important part of this step is to consider the best possible strategy when deciding which tasks will be done in parallel and which ones will be performed sequentially.

Describe how each activity should be performed. It is important not only to list the activities, but also to describe how they should be done by the project team. For example, if translating all essential documents into the local language is one of the activities of the clinical trial start-up, the plan must describe how this task should be carried out.

Test the planning tool before final implementation. During this process, it is important to check whether the duration of each activity is realistic and if the critical path reflects the best possible strategy to be followed by the project team.