Full development plan execution

Various methods have been and are used for the calculation of internal costs, two of which have been published widely the Hoechst Marion Roussel model, derived and published by Thom Hill (Hill and Hubbard 1996) and the MSD BARDS model (Papazian and Wise 1995). A reliable and reproducible method must include the calculation of the cost of a full time equivalent (FTE) employee for each function or task involved in executing and managing the project. Hill s model (Table 42.4) provides a useful illustration of how this may translate into sterling or dollars. This exercise is in itself useful (i.e. even if there are no definite plans to outsource), since clinical development functions are working increasingly in an environment of cost containment. Obviously, such calculations also provide a necessary basis for the comparison of internal costs vs. proposed CRO costs for... 

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