Clinical development plan process improvement

The importance of documenting internal processes in the form of SOPs has already been mentioned. Any activity forming part of the development plan is a process. Each SOP should be looked on as a dynamic document and opportunities for improving each process should be sought continually. For example, the time that elapses between the last patient completing a clinical trial and production of the statistical report is an activity very much on the critical path. 

A well planned simulation project increases the likelihood of providing meaningful and timely simulation results that will enhance the design and improve the efficiency, robustness, power, and informativeness of preclinical and clinical studies. An increase in the efficiency and power of clinical trials should reduce the number of studies and time needed to complete the drug development process with the resultant reduction in cost of pharmacotherapy to the consumer. 

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