Once the project plan template is developed and implemented, the project manager should customize the tool according to study
specific requirements. The next step is to lock the planning by saving the baseline—a screenshot of the activities and timelines
expected to be accomplished. The baseline should be saved as early as possible after initiating trial activities to evaluate
(throughout the project) any deviations from initial expectations. It is very important that the tool is updated on a regular
basis with the actual data in real time and that it is shared with the project team accountable for the deliverables, as well
as with the senior management to show study progress or for the purpose of escalating trial issues. A Web-based tool is the
most suitable option for data entry and verification. Control phase Project control means evaluating the system put in place using standardized metrics to measure progress and quality. Project
managers can easily lose control of the project and its scope when they do not manage based on the project plan. Deviations
from the study baseline should be measured and tracked in a timely manner to identify issues, assess the impact of the changes
in the plan, and apply corrective actions. The risk management plan should be followed in parallel with clear mitigation strategies
and contingency plans, such as the activation of backup countries or the selection of additional sites. In this way, the delays
are predicted with sufficient time, reduced, and resolved efficiently. Lessons learned and metrics from current and past clinical trials are helpful to improve the project planning tools, re-design
the processes, better estimate the timelines, and implement adequate strategies to conduct studies. A big issue in a majority
of organizations is that the best strategies are not organized in a way that people can use—usually, SOPs are not enough to
guarantee employee performance. The development of a planning system where the knowledge strengthens the companies and remains in the organization allows
teams to learn from past projects. Even if a project team does not have the knowledge to conduct a global clinical trial,
the study can be performed with a good chance of success. Diego Glancszpigel * is director, Clinical Operations, Latin America, at PAREXEL International, email: diego.glancszpigel@parexel.com
Graciela Rácaro is senior director, Clinical Operations and Peri-Approval Clinical Excellence (PACE), Latin America, at PAREXEL International. *To whom all correspondence should be addressed.
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