Change Management in Clinical Research: The Sponsor Playbook

In clinical research, adopting new technology to solve important challenges is often a colossal effort. It’s easy to come up with and to try selling a great idea, and it can feel good to buy the idea. But without the right approach to change management, everything can (and will) fall apart. 

According to Dr. Mary Lippitt’s Managing Complex Change model, there are five elements that must be in place for effective change management: Vision, Skills, Incentives, Resources, and an Action Plan. Remove even one of these components, and change is doomed to result in confusion, anxiety, resistance, frustration, or false starts.  

So, how can study sponsors who are already pulling their hair out over a hundred trial obstacles overcome the risk, inertia, and resistance surrounding the adoption of new solutions?  

That’s exactly what the Technology Change Management panel at ProofPilot's recent CORE Symposium aimed to answer. The panel, co-hosted by Korio, brought together three experts with firsthand experience in the good, the bad, and the ugly of change management:  

• Jenn Curry, Biogen (Large pharma perspective) 
• Liza Micioni, Tris Pharma (Small pharma perspective) 
• Ryan Keane, Korio (Vendor perspective) 

Selling the vision: driving internal support for change

Know your audience

Two of the five components of Dr. Lippitt’s model are Vision and Incentives. Where change management often fails is when decision makers don’t see the value or the big “why.” We see this challenge especially in cross-functional groups: one individual may have a vision, but not everyone sees how they’ll personally benefit from that same change.  

Three approaches that may help, according to the panelists: 

1. Learn the unique incentives for each stakeholder and tailor the presentation so it’s not the same for everyone. 
2. Share only what each person needs to know. Options can be overwhelming, especially when they share many similarities. Frame it as “This is what we’re not doing, this is what the guidelines require us to be doing, and this is why we need this solution.” 
3. Engage the vendor—give them a playbook of who’s part of the conversation and what ails them, and let the vendor help solve. 

Knowing your audience also means engaging senior leaders and staff levels appropriately.  

For senior leaders, emphasize: 

• ROI (but remember, ROI is not just cost savings – it can be new capabilities, cycle time reduction, higher productivity, or job satisfaction) 
• The ability to pivot when things don’t go as planned 

For staff levels, ensure to:

• Provide early awareness 
• Ease them into the change 
• Give them enough information without giving too much (to prevent overwhelm and confusion) 

Start small

Effective change management doesn’t bite off more than it can chew. Starting with a modest rollout of just one opportunity or study can help to relieve some resistance and anxiety around adopting new solutions by reducing the perceived risks. It also gives time to grow and build the partnership—another factor of great change management.  

Success on the front lines

In clinical trials, change often rolls down to the study manager. We asked Jenn, Liza, and Ryan what they believe ensures effective change management at the study manager level.  

1. Quick Cards: Bite sized bits of knowledge to help guide the study managers through what they’re responsible for, what they need to know, and how to approach it. 
2. Test Runs: Give study managers the opportunity to run a patient through the new tech from start to finish. It’s important for all stakeholders to be on board with who goes first, next, and so on. 

We're in it together

As a team rooted in all facets of the clinical research and health tech industry, we at ProofPilot understand the distinct complexities of change management in clinical research. Here’s how we support the successful adoption of our solutions:

• Hiring the best talent: our customer success team is made of former pharma or site-based researchers. Do not underestimate the value of being seen! 
• Ensuring a deep understanding of and solving for each stakeholder’s unique pain points 
• Providing frequent, ongoing support and management of implementation with our exceptional support team 
• Cultivating strong and meaningful relationships with our sponsor partners 

ProofPilot's CORE Symposium

This insightful change management discussion took place at ProofPilot’s first-ever CORE Symposium at the historic Fenway Park. CORE is an intimate clin ops event focused on tactical tools and strategies for study sponsors in a world of conferences that prioritize innovation over reality.  

Want in on the next event? Learn more about CORE Symposium here and sign up for updates.