- David Jones
- Jan 14
- 3 min read
How cross-functional communication, role clarity, and genuine collaboration drive operational excellence in clinical research.
Introduction: The Human Factor in Clinical Operations
Live from COG Bay Area, the latest episode of The PBC Group’s COG Review podcast brought together senior voices in clinical operations, including Kimberly Guedes, VP Clinical Operations at Intensity Therapeutics, to discuss a perennial theme: optimising stakeholder engagement for the timely delivery of clinical trials. With delays affecting the development of new treatments, understanding how people, processes, and real-world constraints interact is more critical than ever.
1. Defining Stakeholder Engagement: Beyond the Basics
Stakeholder engagement in clinical research is frequently reduced to a checklist or series of updates. Yet, as Kimberly Guedes explained, true engagement means recognising everyone—sponsors, CROs, vendors, regulators, sites, and especially patients—as part of a unified team. She challenged the notion of rigid boundaries; instead, she encouraged erasing the lines between “vendor,” “site,” and “sponsor”. The aim is to build trust and transparency, making honest conversations about constraints and realistic timelines possible.
2. Common Pitfalls: Where Clinical Trials Go Awry
The discussion surfaced key reasons for trial delays: lack of honest conversations, misaligned priorities, and failure to understand stakeholder constraints from the outset. For instance, academic centres may take nine months or more for contracting—a reality often overlooked until timelines start to slip. As Kimberly Guedes highlighted, neglecting candid dialogue before protocol finalisation means missing potential efficiencies and setting the project up for failure before it begins.
Other dangers include uncertainty of outcomes, repeated rework due to unforeseen changes, and eroding team morale. These problems invariably stem from poor communication and insufficient collaboration.
3. Building Blocks for Success: Communication and Clarity
So, how can teams avoid these pitfalls? The answer lies in the fundamentals:
Project Planning: Invest early in cross-functional kickoff meetings—not just virtual, but ideally face-to-face encounters that foster genuine connection and clarity around expectations.
Role Clarity and Team Development: Move beyond silos. Train each other, not just internally but across organisations. Make sure each person knows not only their own responsibilities but how these fit within the wider team, and update everyone as team members change.
Active Listening: Kimberly Guedes’s standout advice was to “listen to understand, not to reply.” It’s about hearing what isn’t being said—unspoken concerns about costs, timelines, or regulatory hurdles—and inviting questions and ideas, particularly from junior voices.
4. Practical Engagement Strategies in a Virtual World
With remote work now commonplace, Audience raised the challenge: how can teams stay engaged when face-to-face is no longer an option? Best practice recommendations included:
Require cameras-on during video calls to gauge engagement and facilitate better communication.
Begin meetings with clear objectives for each attendee and explicitly invite focused participation, discouraging multitasking which can undermine efficiency.
Make time for personal check-ins—asking about family, interests, or wellbeing—to reinforce the human connection that drives collaboration.
5. The Escalation Dilemma: Changing Partners versus Working Through Issues
What happens when, despite best efforts, a partner continually underperforms? Armin posed this difficult question. Kimberly Guedes emphasised escalation—taking issues to leadership rather than immediately severing ties—preferring resolution over disruption. However, she acknowledged that, on rare occasions, changing vendors may be unavoidable. The key is to weigh the cost, time, and relationship impacts before making such moves.
6. Continuous Review and Knowledge Sharing
Clinical trials are inherently complex and unpredictable. Kimberly Guedes urged teams to plan, review, and adapt continuously, course-correcting as needed with input from all stakeholders. Sharing learnings—both successes and stumbles—is vital for collective progress, not just within a company but across the sector.
Conclusion: Operational Excellence is Human Excellence
Optimising stakeholder engagement is not about flawless processes or cutting-edge technology alone. As reflected in the podcast, it depends on treating every team member as part of a collaborative ecosystem—where honesty, respect, and inclusivity form the bedrock of operational efficiency. Whether in-person or remote, alignment and communication remain the essential ingredients for bringing effective treatments to patients faster.
For leaders in clinical operations, the takeaway is clear: effective stakeholder engagement is a skill as much as a strategy. Embrace it, refine it, and share what you learn.
For further insights from senior clinical operations professionals, listen to the full episode of COG Review Building Better Clinical Studies or visit thepbcgroup.com.
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