Once the project plan template is developed and implemented, the project manager should customize the tool according to the
Then, lock the planning by saving the baseline. This is a screenshot of the activities and timelines expected to be accomplished.
The baseline should be saved immediately after the initiation of the clinical trial activities. This allows for an evaluation
throughout the project of any deviations from initial expectations. It is very important that information be updated on a
regular basis, with the accruals in real time and shared with the project team accountable for the deliverables as well as
with senior management. A Web-based tool is the most suitable option for data entry and verification. With a clear understanding
of the activities, to be done, staff can organize their activities taking into account the priorities. And managers can better
project and assign resources to the project.
The purpose of any plan is to create a tool—a tool for control. Project control means evaluating the system in place and using
standardized metrics to measure progress and quality. Project Managers can easily loose control of the project and its scope
when they do not manage to 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.
A Product Team Checklist
A risk management plan should be followed in parallel with clear mitigation strategies and contingency planning (the activation
of back-up countries, or the selection of additional sites). In this way, the delays are predicted with sufficient time to
resolve them efficiently. This also allows you to anticipate and address the impact of changes on the planned dates.
A final note
It is important to understand that metrics are just performance indicators. Metrics from current and past clinical trials
are helpful to improve the project planning tools, redesign processes, better estimate timelines, and implement adequate strategies
to conduct the studies. But they do not make a study successful.
The success of any project is in the planning phase. If all the steps to achieve the goals in the project are defined at the
outset, including timelines, and they are understood by the project team, the chances of failure are much lower.
Complexity of Clinical Trials
The way clinical trials are conducted has changed significantly in the last 20 years. The turning point was the creation of
the GCP guideline and the globalization of clinical research. Running a clinical trial today has become a highly complex endeavor.
Number of Competing Studies in Breast Cancer (As of December 08)
Bigger: Clinical trials are larger than they used to be in the past. Science is making progress in almost all therapeutic
areas—cardiology, infectious diseases, oncology, etc. New compounds require studies with larger number of patients to demonstrate
product superiority over the existing alternatives.
More: The biopharmaceutical industry is under intense pressure to develop new medicines due to patent expiration of several
marketed products. The focus on innovation is one of the drivers for the increase in the number of clinical trials that results
in more studies of fewer compounds.
New guidelines: The biotech industry has produced a new way of developing medicines, which has significantly increased the
number of clinical trials. Additionally, new guidelines have been introduced in terms of how clinical trials using biological
products should be performed.
Global customers: The increasing attractiveness of end markets for biopharmaceutical products in emerging regions has forced
the biopharmaceutical industry to look for new markets in which to place their studies.
Diego Glancszpigel is Vice President of Clinical Operations for Latin America at PAREXEL International. He can be reached at firstname.lastname@example.org