A Fresh Way To Look At Your Clinical Research Project

Project management techniques can have their 15 minutes of fame and can then fall into relative
obscurity. Others live on in their original or an adapted form and become integral to the project
management body of knowledge.

System thinking

System thinking is not new, but I don’t see it being used very much in clinical research projects.
Instead, we tend to use traditional tools like project risk analysis and stakeholder analysis. One of
the problems with these techniques is that they exist in isolation and miss out on uncertainty
surrounding the project as a whole by ignoring the interactions between disparate risks.
System analysis allows you to look at your project in a holistic way. It is a simple and effective way to
look at the risks, opportunities, financial implications, and stakeholder interactions.

Agile Project Management

Agile project management is also not new but is currently very fashionable.
It was developed by the information technology (IT) sector and in February 2001 they published a
set of principles designed to improve project performance. The principles go beyond IT projects and
are essentially just good project management.

The downside is applying agile project management in a highly regulated area like clinical research.
What you can do is adopt the philosophy, concentrate on what is essential, keep in mind the end
user and open ‘fat’ channels of communication.

An increase in complexity

Another popular area of project management research is complexity. The increasing complexity of
protocols inevitably results in more complex projects. You need to define and recognise complexity
in projects and what you can do to mitigate its effect.

Traditional risk management is event-based; discrete events are identified and their importance is
estimated by considering the probability of the event occurring and its impact on the project. What
it does not consider is the impact of processes and people. The theory of constraints is useful in
identifying problematic process and relational risk all about the people.

Relational Risk

Projects are not only technical systems but also social systems and both are important causes of
uncertainty. Relational risk is about the high levels of uncertainty in respect of the social systems,
how people behave in Pharmaceutical Companies (Pharma), Clinical Research Organisations (CRO),
and other stakeholder organisations that have been brought together to deliver projects.

The well-established concept of project risk, where risk is considered as both a threat and an
opportunity also applies to relational risks, however the focus of relational risk management is about
dealing with the high level of uncertainty of the relationships formed by the actors in the project
coalition, rather than on the likelihood and consequence of individual events occurring. This focus
on the uncertainty around collaborative relationships does not replace traditional risk management;
rather it is an enhancement of the risk management.

The CURED Framework

Detailed analysis of our academic research in this area enhanced by years of experience has resulted
in the development of the CURED Framework which is specifically designed to help you overcome
the issues related to relational risk.

Our upcoming course will demonstrate how you can use the CURED framework to mitigate these
risks. The five elements of the CURED framework are the Contract, Understanding, Resource,
Education and Delegation. Underneath these five elements sit 40 Meds that enable you to make
small but significant changes to improve project relationships and enhance project performance.

To learn more about the CURED framework, sign up for our course.

Published on Nov 08, 2022 by Gareth Cartman