|
|
|
|
|
|
|
project activities so that the influence of time changes in each activity and the overall project completion time is clearly visible. The key output of a network plan is the critical path, that sequence of activities which determines the minimum duration of the project. It also defines lag times or buffers for all other activities. Reduction of the time to completion is possible only by doing critical path activities quicker or by rearranging the work to do activities in parallel instead of in sequence. Tracking of time must focus primarily on critical path activities (see Fig. 4). |
|
|
|
|
|
|
|
|
Because pharmaceutical development of different drug candidates follows a broadly similar course largely set by scientific method and regulatory requirements, a formal standard plan is a very helpful tool. It summarizes the knowledge, experience, rules, and definitions of a development organization and serves as template and checklist for new project plans. Its main value is as assistance to ensure completeness of a specific project plan whereas the appropriate sequence of studies should be carefully optimized for each individual project using the considerations of the previous sections. |
|
|
|
 |
|
|
|
|
Standard plans are normally in the form of a network plan, showing |
|
|
|
|
|
|
|
|
all activities (work packages) required to complete a project in terms of scientific, legal, and regulatory requirements |
|
|
|
|
|
|
|
|
company internally defined decision points, milestones, evaluations, etc. |
|
|
|
|
|
|
|
|
the linkage of these activities as derived from technical, scientific, ethical requirements or as internally defined |
|
|
|
|
|
|
|
|
the standard time estimates for all work packages |
|
|
|
|
|
|
|
|
the organizational unit responsible for the work package |
|
|
|
|
|
|
|
|
the definition of the output of each work package |
|
|
|
|
|
|
|
|
The computer network software calculates an overall duration and shows the critical path as well as time buffers. All activities in individual project plans should relate to these standard work packages through a description term or number. |
|
|
|
|
|
|
|
|
To be a reliable tool, the standard plan must be regularly updated by the responsible project management department to include new regulatory and legal requirements and changed company procedures. Standard time estimates for experimental studies should reflect the time targets of the responsible departments for executing the task under normal conditions |
|
|
|
|
|