3 Essential Elements of Change Management Within Clinical Research Operations

Kayla Fargo
February 26th, 2019

Last fall, we published a report on the State of Technology in Clinical Research, highlighting some of the key challenges shared among more than 800 clinical research professionals who participated in our survey. The results of the survey weren’t surprising to us – there’s enormous opportunity for growth and improvement across all facets of clinical research operations.

To address current challenges and capitalize on these growth and improvement opportunities, clinical research organizations must be willing to evolve and change behaviors. The key to effective, productive change within a research institution lies at the nexus of people, process and technology.

“People, process, technology” isn’t a new concept. It’s a basic framework that’s been guiding change management across different businesses and industries for decades. However, in an industry as complex and ever-changing as clinical research, it’s easy to lose sight of this fundamental guiding principle when implementing change.

When planning and implementing improvements to your research operations – whether that means hiring new people, creating new processes to support billing and collections, or adopting a new piece of technology – this list of considerations will help ensure you’re not forgetting the basic principles of change management. Refer to this list to make sure people, process and technology are equally balanced considerations of your change management efforts.

People: Communication is Key

Identify key stakeholders, champions and possible opposition

Before you implement a change, it’s critical to identify and empathize with the different audience segments that may be impacted. Change can create uncertainty and resistance, so it’s important to keep your audience’s perceptions in mind throughout the change management process.

For example, perhaps you’ve uncovered an inefficiency in your current patient recruitment practices that you think could be resolved by centralizing recruitment efforts under a single person or team of people. Before moving that change forward, think how the people currently involved in patient recruitment might interpret that shift. Will they welcome the opportunity to focus on non-recruitment-related responsibilities, or will they feel threatened that a piece of their day-to-day job is being shifted elsewhere?

Conversely, consider how the person or team to whom this task is shifting will respond. Will they be excited to take on more recruitment-related tasks, or overwhelmed by adding these responsibilities to their already-full to-do list?

Clearly communicate all elements of the change with appropriate audience segments

Once you’ve identified the audience for your change and have thought through how different segments of that audience might interpret and respond to your proposed change, establishing open lines of communication with the people involved and impacted is key. At the very minimum, your communication plan should answer the following questions:

  • What’s changing and why?
  • Who is responsible for executing the change you’ve proposed?
  • What are the desired outcomes of the change you’re implementing, and how will you measure progress towards those goals?
  • How should team members share feedback about the change, and how will that feedback be considered or acted on moving forward?

Process: Focus on Fixing What’s Broken

Understand Current State

It’s impossible to improve something you don’t understand. Prior to implementing a new process or changing a current procedure, take the time to understand current state.

For example, if you’ve identified sponsor invoicing as a challenge for your research organization, map out the current invoicing workflow. Who’s involved in each step of the current process and what tools do those contributors rely on to complete each task? Where are there gaps, inefficiencies, or vulnerabilities?

Prioritize Quick Wins and High-Impact Process Improvements

Building on our above example, once you’ve mapped out your sponsor invoicing process, prioritize improvements based on changes that will have the fastest and greatest impact. If sponsor payment depends on data being entered into an EDC, for instance, consider changes you could enforce to ensure EDC data entry is completed in a more timely and consistent manner across all industry trials. Develop a standard operating procedure and training materials that enable staff to complete that task efficiently and accurately.

Technology: Optimize Your Operations with Infrastructure That Enables Scale and Growth

Implement Technology that Complements and Elevates Your People and Processes

Technology is the final piece of the change management process. Once you have the right people and processes in place, making technology decisions that support those two pillars should be far simpler. Technology should be viewed as an enabler of operational improvements, not a solution in and of itself. 

As you consider different research systems to implement at your organization, consider who a system will impact and how it will influence their day-to-day responsibilities. For example, clinical trial management systems (CTMS) are used by a variety of research staff, particularly when implemented at the enterprise level, from clinical research assistants (CRAs) to institution leadership. Include all of these individuals in your technology discussion before purchasing, so you can be positive the system you implement will enhance workflows for all involved and address any bottlenecks in your current processes. When choosing technology for your research operations:

  • Identify tools that will enable people to improve results
  • Implement solutions that automate tasks and streamline processes
  • Consider how adopted tools will enable organizational scaling and growth  

Learn more

People, process and technology are fundamental to any successful operational change. Attention to all three is required to implement significant and lasting improvements to research operations. To learn more about bringing effective change management to your organization watch our recorded educational webinar, Brining Effective Change Management to your Organization: The University of Michigan’s Story presented by Teri Grieb, PHD, Senior Director for Research at University of Michigan Medical School.

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Bringing Effective Change Management to Your Organization: The University of Michigan’s Story

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