Have all relevant guidelines been identified and their content been considered?
Do the studies address all product performance statements of the Target Product Profile?
Have all local requirements for the target countries been investigated and considered?
Have marketing requirements been defined and incorporated?
Have all necessary data and qualitative and quantitative material prerequisites for each study been planned with sufficient lead time?
b. Shortening of the Critical Path
Are all work packages on the critical path essential for the start of their successors or can some be completed independently?
What is the minimum output of each critical path study before its successor can be started?
e.g., What length of toxicological exposure is necessary before the start of Phase I?
What part of Phase I studies must be completed before starting the first phase II study?
Can phase III be started based on an interim analysis of phase II studies, rather than waiting for their final evaluation?
What stability-supported shelf life of the formulation is needed before the start of a particular study?
Where are final quality checked reports necessary for continuing the project and where is a draft report sufficient?
How can the study evaluation be expedited, e.g., by concurrent or remote data entry?
Is it possible to increase the assumed patient enrollment rate to reduce the treatment time of a study?
Which task is likely to overrun the estimated duration because of unexpected technical problems and can this risk be reduced by adding resources early?
In the optimization phase, standard duration estimates for work packages are replaced by realistic calendar start and finish dates. Now, the activities to be carried out by development departments can be scheduled with reasonable reliability for the following 12 year time frame. If resources in the required time window are limited, the possibilities of adding resources or of external contracting should be considered early.
