| Sheila Kelly at ICON Clinical Research examines the development of data management metrics for practical use within the pharmaceutical industry
“Businesses that succeed constantly assess themselves and improve in all dimensions of their business; metrics are the cornerstone of their assessment, and the foundation for any business improvement” (1). Within the pharmaceutical industry huge emphasis is placed on cost containment of clinical trials. There is a growing trend that encourages us to scruntinise each project task with a view to reducing costs. This is particularly evident for support services, such as data processing; contract research organisations (CROs) are driven to provide robust resource plans and budgets that accurately reflect the project’s activities.
THE PROJECT PLAN
The successful project plan has four successive stages – initiation, set-up, maintenance and closeout. In stage one, the scope of the project is defined by identifying the main aims; stage two underpins the resources required to perform these tasks and the associated costs; stage three progresses to project implementation and fulfilment of the original goals outlined in stage one, and stage four is the evaluation period when corrective measures are put in place and lessons learned are carried forward to the next project (see Figure 1a). All of these stages are interdependent and in ideal conditions rely upon having the correct information to hand at each stage of the project’s development in order to advance to the next stage.
However, when we apply this model at the initiation stage of an actual project, we are often forced to jump back and forth between project stages. Frequently the project manager or contract analyst is requested to assign resource and develop the project budget in the absence of the full knowledge of the sponsor’s goals and objectives that should have been completed at stage one. The project frequently begins at stage two (see Figure 1b), where there is an emphasis on cost development and resource allocation. In an effort to keep the project plan intact, the experienced contract analyst will compile available information from all sources, such as information on previous studies taken from the in-house project database, and will solicit input from therapeutic and technology experts.
All stages of the project are interdependent: no one stage of the project is finished until the project is complete in its entirety. For example, stage two of the project management plan may be revisited throughout the project’s lifecycle to adjust resource and costs in order to reflect changes in the project specifications. |
