In the clinical research industry, it’s no secret there are many moving parts, and sometimes, some aspects of research are part of outdated processes or new activities are put in place to meet current needs. If not updated, these outdated processes could hinder research sites, ultimately affecting the cadence of which they move a protocol through the phases.
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, and technology” isn’t a new concept. It’s a basic framework 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 hiring new people, creating new processes to support new activities, such as billing and collections, or adopting a new piece of technology – this list of considerations helps 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 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 participant recruitment practices you think could be resolved by centralizing recruitment efforts under a single person or team of people. Before moving forward, think about how the staff currently involved in recruitment might interpret the 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 staff member 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 thought through how different segments of that audience might interpret and respond to your proposed change, establishing open communication lines with everyone 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 with the fastest and greatest impact. If sponsor payment depends on data being entered into an electronic data capture tool (EDC), for instance, consider changes to ensure EDC data entry is completed in a more timely and consistent manner across all industry trials. Develop a standard operating procedure (SOP) and training materials enabling staff to complete the task efficiently and accurately.
Technology: Optimize Your Operations With Infrastructure Enabling Scale and Growth
Implement Technology to Complement and Elevate 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 to support those two pillars should be simpler. Try to view technology as an enabler of operational improvements, not a solution in and of itself.
When considering different research systems to implement at your organization, take into account how a system will impact and influence staff members’ day-to-day responsibilities. For example, when implementing a clinical trial management system (CTMS) at the enterprise level consider the variety of research staff who will utilize the tool, from clinical research assistants (CRAs) to institutional leadership. Include everyone in your technology discussion before purchasing, so you are positive the system you implement enhances workflows for all involved and addresses any bottlenecks in your current processes. When choosing technology for your research operations:
- Identify tools that enable people to improve results
- Implement solutions to automate tasks and streamline processes
- Consider how adopted tools enable organizational scaling and growth
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.
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