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Planning for Complex Change at Your Organization

The only constant in clinical research is change. Researchers are always innovating, making it a necessity to navigate complex organizational change. Technology continues to advance clinical operations, and organizations must proactively adapt. How can your organization stay on top of it all?

Anticipating Change and its Outcomes

When thinking about change, it may be helpful to think about how to reach your end goal. With this in mind, there are three outcomes typically occurring from change management:

There are different approaches leading to these outcomes, and many pitfalls standing in the way of your organization achieving optimal state (or even improvement).

Common Pitfalls to Complex Change

More often than not, if your organization’s change results in either “improvement achieved” or “no improvement achieved”, there are various pitfalls it could be attributed to. The most common ones include:

Methods to Avoid Pitfalls

While some pitfalls may be inevitable, there’s a way for your organization to have a plan in place to mitigate the effects. A continual loop, the core method enables you to constantly assess your organization’s current state as you anticipate complex change.

Current State Assessment

Assessing your organization’s current state is a great starting point as you anticipate complex change. However, not much time should be spent in this stage; it should be relatively easy to identify where you’re currently at. As you do, it’s important to break it down into three levels:

Ideal State Definition

As you define your organization’s “ideal state” a key question to answer is: If you could simply create an ideal state to address your identified pain points, what would the day-to-day operational state look like?

Just as there’s not one right answer to this question, no one person can define this. Working together to define your organization’s ideal state can help act as a guiding point for your change management effort. It’s also not limited to one definition; it can be related to tech implementation, optimization, or many other definitions.


In the alignment stage, identify who are the key individuals at each level who helped determine ideal state. This is critical before targeted resourcing, because resourcing should reflect what stakeholders have identified and defined as ideal.

Think of this stage as overcoming hurdles. With this mindset, if you’re aligned with everyone involved, then everyone will be on the same page when an escalation happens. If not, there will be a disconnect, and it’ll be difficult to get change management efforts back on track.

While this is one piece to the puzzle, the alignment stage never stops. It’s important to ensure everyone is aligned before the project starts; but in order to keep things moving, alignment will have to be continual between stakeholders.

Targeted Resourcing

How does the project resourcing align to the key decision makers from defining the ideal state and alignment efforts? Everyone needs to understand the current state to execute on it.

In this stage, you should try to use what was already defined as ideal, and you’re training to remain aligned with everyone in order to achieve this. If you’ve identified what is ideal, you’re aligned, and you’ve resourced accordingly, it’s likely you will hit the “improvement achieved” benchmark.

However, you want to make sure your goals are set up so you can achieve improvement. Take a clinical trial management system (CTMS) example: You want to improve transparency in reporting. Technology can certainly help your organization achieve its goal, but there needs to be more information, such as:

Lacking an in-depth goal may set your project team up for failure. The more granular you are in your goal setting, the better.

Safety Nets

Change over time is inevitable, both operationally and technologically. Everyone must work together to structurally account for change in real time, keeping your organization in its ideal state.

When’s the right cadence when it comes to assessing your organization? Doing a full assessment every three years can help ensure your organization is still on the right track. However, from time to time, it’s helpful to cross functionally review workflows, so you’re not starting from scratch at each assessment. With these systems in place, you can continue to make incremental change and stay aligned in your organization.

Note: This article summarizes a session from the 2024 Onsemble Conference

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