Plan development budget

A sponsor of a medical product entering the development phase must have a clinical development plan, which is created by experienced executives and consultants having expertise and experience in the disease state for which the product is intended. Once the plan is created, with appropriate input from regulators, the plan drives a clinical development budget, with consideration of the desired timeframe for projected producf approval. After the plan is created, the management team determines the "make vs. buy" strategy, which determines the elements of fhe plan that will be outsourced. 

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Once an organization determines a facility need, preliminary planning and budgeting begin. Some call this a feasibility study. In preliminary planning, a design team estimates the scope of the project and creates a general concept for it. The team may develop and evaluate alternative concepts. 

The way many companies identify resource requirements is to solicit resource budgets from each department covering a 1 to 5 year period. However, before the managers can prepare budgets they need to know what requirements they will have to meet. They will need access to the corporate plans, sales forecasts, new product development plans, marketing plans, production plans, etc. as well as the quality policies, objectives, and procedures. 

Usually, there will be a department or individual with a central role in the planning process. You should spend time with these staff developing an understanding both of the planning process and the evaluation criteria they use for including expenditures in their budgets. If your project has top level backing, some costs may be absorbed by corporate this is most likely to be the case if costs are incurred well ahead of any benefits. 

Controlling is the central activity during implementation. The most important tool in this process is the plan that was developed to define the three parameters of the project - specifications, schedule, and budget. Performance is measured against these standards. Controlling involves three steps ... 

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