Milestones, full development

One of the measures of the quality of the preregistration clinical programme is the total time from the decision to enter full development to the first regulatory approval in a major market. It is also important to monitor quality in other ways. One option is to assess the frequency with which predetermined milestones are achieved. More subtly, quality can be assessed by examining the number of incomplete, inaccurate or indecipherable CRFs that are returned or the number of protocol amendments made which are not based on new information. Milestones may still be achieved when quality is poor, that is, when there is inefficiency, but this means that they were wrongly established and can be improved if efficiency improves. 

Internal summary reports and formal proposals for management are often assembled in preparation for development milestones (e.g., candidate selection and full development decision). Research reports for critical data are written for products as they progress through development. However, reports for failing studies or discontinued programs are often not prepared and these can be equally useful since history tends to repeat itself. Because of the time and resources required to prepare such reports, a conscious decision should be made if the value added warrants the effort. 

One milestone in the evolution of Fourier transform spectroscopy which will probably be reached in the next three to five years is the full development of efforts by some manufacturers to market visible/UV Fourier transform instrumentation. In fact, the process has already begun on a small scale.56 To be sure, however, this effort even at its height will not be on the same level as present marketing efforts in infrared spectroscopy.57 This commercialization will occur in order to provide instrumentation designed to study the problems mentioned above as well as other problems currently unforeseen. As Connesl7 pointed out, this development is a mark of maturity for the Fourier technique. 

Internal summary reports and formal proposals for management are often assembled in preparation for development milestones (e.g., candidate selection, full development decision). 

Figure 3.5 A calculation of the costs associated with a full-time equivalent (FTE) analyst. (Courtesy of Milestone Development Services, Newtown, Pa., USA.)...

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