PMI® Switzerland Chapter

Risk Management in Clinical Trials

Risk Management in Clinical Trials

Geetanjali Bhat
Author: Geetanjali Bhat, PMP

The success of a process or a project depends on how well it is planned, organized, implemented and managed. Project managers in clinical study operations take on many challenges including multiple stakeholders, budget control and stringent quality and regulatory requirements. This event’s key note speaker Ms Gessami Sanchez Olle who brings along her tremendous knowledge and experience gave us a very interesting session of Clinical Trials in Project Management.


Clinical trials are highly complex enterprises that demand professional management at every stage and level. Utilization of the project management methodologies along with the conventional techniques would increase the chances of execution of clinical trials in a cost and resource effective, and time-efficient manner.

Although my background is not in pharma and I do not have much knowledge on clinical trials, I was glad to attend this event because I could gain great insights on how risk management can be applied to clinical trials.

The night began with a definition of “clinical trial” as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. We then went through the process of discovery to commercialization of clinical trials.  

Phase I to Phase IV is a complex journey of a clinical trial. The journey to Phase IV involves the internal and external stakeholders.

Project management becomes more complex due to known risks (known-unknown) and unknown risks (unknown-unknown/unforeseeable risks). In the pharma industry there are added uncertainties from the process of scientific research.


The PMBOK defines risk management as the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks.

The application of risk management in a clinical trial is implemented through the process of risk management from the identification of a risk to its monitoring.

Risk management has immense impact on the success of a project, along with risk-based monitoring methodologies (RBM) that can be applied in a clinical trial that include centralized off-site and adaptive on-site. RBM is a clinical trial-monitoring technique that fulfills regulatory requirements but moves away from 100% source data verification (SDV) of patient data.

At the end of the session, we learned how Phase Study I, Phase Study III and Phase Study IV were conducted for a clinical trial along with the challenges that are faced therein.

along with other applications can go a hand in hand to

project management in clinical research

along with other applications can go a hand in hand to

I would like to summarize that project management along with other applications go hand in hand to enhance the process of clinical trials. Risk management can be applied well in the processes mentioned in the PMBOK for clinical trials to achieve most of its success factors.