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New Year, New You? Using Change Management for Digital Clinical Trial Transformations

Person's hands holding tablet covered in charts

By Rachelle Stover, MPH, CCMP

With the start of a new year, both people and organizations begin thinking about change. Perhaps there’s a new technology or software your clinical trial organization would like to implement. Or maybe you want to take a paper process and make it digital

Once you’ve decided on a new software or process, you may find yourself asking, “Now what?” The answer to that is simple: focus on change management

Change management is a strategy where people are led through a change to see the expected benefits. Organizational change takes a long time and requires consistent planning and resources. Moreover, change is hard

Humans are psychologically wired to resist change, and 70% of business transformations fail without properly formed change management strategies. If your clinical trial organization wants a new technology or workflow to make you more efficient, you need to implement a well-planned change management process from the very beginning. 

Look for a software vendor who is willing to help you with your change management process. We discuss how to evaluate new software in our Fundamentals of Change Management course

Then, focus on three key change management strategies: forming a change management team, obtaining leadership buy-in, and winning stakeholder engagement.


1. Forming a change management team

A good change management strategy can’t exist without a good change management team. By forming this team, you won’t just ensure that a change takes hold: you’ll ensure that it takes hold quickly and that your employees feel comfortable with it. 

Several key players will need to join this team: 

  • A change management leader (you or another employee passionate about the new software or process and about change management) 
  • A member of the executive leadership team 
  • Change agents (any employees who embrace the change) 
  • Super users (employees comfortable with the technology the change involves) 

The people in these roles should have a concrete understanding of the change and why it’s happening, and they should be willing to share this information with the rest of your team. Your change agents and super users should also receive training on the new software or processes first so they can help train or answer questions for other employees. 

People can have multiple roles on a change management team, particularly if they’re well-versed in the upcoming change or if your organization is small. But you need to make sure multiple departments from across your organization are represented. 

For more on how to assemble your team, check out our full change management course

2. Obtaining leadership buy-in

To make your new processes or technology work, leaders have to be involved in every step of implementation. If you obtain leadership buy-in at project kick-off but then stop talking to your leaders, they won’t have enough information or emotional investment to support your initiative if problems arise. 

Your team will probably see executive leaders, like vice-presidents or members of the C-suite, as the “face” of the change across the company. These leaders can set a positive tone, encourage other employees to get on board with the change, and make sure you have the time and resources you need to implement it. 

To make this a reality, keep the leadership team constantly informed of what’s going on with the change implementation process and how they can support your team. Ensure that you’re honest and direct about what’s working well and what’s not. That way, the leadership team can help you craft a new training or implementation plan whenever it’s needed.


3. Achieving stakeholder engagement

Finally, you can’t have an effective change management strategy without consistent stakeholder engagement. To learn more about crafting this strategy, check out our free course.

In the context of change management, a stakeholder is any individual at your organization that’s impacted by the change.

If you’re implementing a change that involves technology, these stakeholders are sometimes called end users. Your end users are the people whose behavior you have to change to ensure your new software is successful. 

A change won’t yield successful outcomes for your business unless all end users are actively engaged with the new tech or process, asking questions, and growing their skills. 

Helping all stakeholders

Stakeholders or end users vary greatly in how they react to change. Some stakeholders may become resistant or even angry, while others may embrace the change as a chance to show off their leadership skills and tech-savviness. 

People who are excited about the change can become your change agents or, if the change involves technology, your super users. But people who are afraid or resistant will need your help. 

Ask yourself, “How can I lead my stakeholders through this transformation?” The answer will look different for each clinical research organization and even each team. Some stakeholders may prefer in-person communication and training, while others may prefer to receive emails or links to tutorial videos. 

Consider offering a variety of training and communication methods so end users can choose the one that works for them. We cover several of these methods in our change management course.

If you’re picking out software, you may also want to ask technology-resistant members of your team to test out the software before you choose it so you know whether it’s user-friendly and intuitive. Think about how new technology and digital processes will work for all members of your team, not just the ones who spend 16 hours a day on the computer.


Embracing change management at your organization

Remember – change is a process, and it’s hard. But it’s not impossible, and the time savings and greater efficiency technology can bring to clinical trials make change worth it.

By forming a strong change management team, obtaining consistent leadership buy-in, and prioritizing stakeholder engagement, you can ensure your change management strategy is successful. Whether you’re switching to eConsent or training your CRCs on how to build digital folders, change management strategies will help you adopt new technology and processes successfully. 

Want to learn more about change management at clinical research organizations? Check out our new course on technology change management. 


About the Author

Rachelle Stover, MPH is a Solutions Engineer at Florence Healthcare. She is also a certified change management professional (CCMP). She has experience supporting large-scale technological transformations at enterprise organizations and employing multiple change management methodologies.