Developing the schedule and determining the budget are done during the planning phase, before initiation of the clinical trails. To develop the schedule, the PM would need to take into account the amount of resources, the amount of team members performing the trials, the budget, and time designated for each task. A WBS will help create the Gantt chart after laying out all the tasks in order, showing dependencies of every task, determining task durations, and finding the critical path. There is also a trade off between having a device completed quickly, cheaply, or that is of good quality (can only pick two). Medical devices and clinical trials should always be of good quality to minimize risk, so the PM will need to see if the budget is large enough to speed up development without jeopardizing quality. The PM should discuss the schedule with all departments to make sure he/she is allocating a reasonable amount of time for each task.
The PM will also need to estimate the total cost of the project to determine the study budget, site budget, and center budget. The budgets will need to be negotiated with the doctors, and other participants like the Clinical Trials PM and department. Picking an appropriate budget during the planning phase is crucial, especially if a clinical trial contract at a fixed price is signed. It will also depend on how many stakeholders and sponsors there are, along with how much each is willing to invest.