- David Jones
- Jan 14
- 5 min read
Updated: Feb 18
How cross-functional communication, role clarity, and genuine collaboration drive operational excellence in clinical research.
Effective stakeholder engagement is essential to successful clinical trial outsourcing, especially for timely study delivery and operational efficiency. Drawing on insights from a Clinical Outsourcing Group (COG) Bay Area session led by Kimberly Guedes, VP Clinical Operations at Intensity Therapeutics, this article explores the actionable principles, pitfalls, and communication strategies that underpin best practice in modern clinical trials.
Kimberly Guedes, Vice President of Clinical Operations at Intensity Therapeutics, brings nearly 30 years’ experience across all phases of drug development to the challenges of stakeholder engagement in clinical trial outsourcing. Her career spans global regulatory leadership, portfolio management, and large-scale process improvements within both sponsor and CRO environments.
The insights highlighted here originate from an interactive keynote at COG Bay Area – a session designed for clinical operations professionals, outsourcing leaders, and vendor partners to address real-world dynamics in multi-stakeholder trial delivery.
Understanding Stakeholder Engagement: The Foundation for Clinical Study Optimization
At the heart of every successful clinical trial outsourcing strategy lies robust stakeholder engagement. Kimberly Guedes explains that stakeholder engagement is a continuous process that acknowledges the diverse priorities, expertise, and constraints of all parties involved, including sponsors, CROs, sites, data managers, statisticians, and most importantly, patients.
Key points raised include:
Multiplicity of Perspectives: Every stakeholder brings unique objectives, operational constraints, and expertise. For example, timelines established by sponsors may not always reflect the practical realities faced by CROs or sites.
Early Honest Conversations: Engaging openly about realistic timelines, deliverables, and constraints from the outset can help avoid rework, budget overruns, and missed timelines.
Blurring the Boundaries: True optimization means moving beyond rigid definitions—seeing all parties as part of a unified team rather than simply as vendors or contractors.
This collaborative approach forms the bedrock of what Kimberly Guedes identifies as a team-based model for successful study delivery.
Building Operational Trust: Communication and Clarity Across the Ecosystem
Poor communication is a major stumbling block in clinical outsourcing arrangements. According to Kimberly Guedes, the consequences of opaque communication or lack of clarity are predictably negative: increased uncertainty, repeated rework, morale issues, and ultimately project failure.
Several operational tactics emerged from the discussion:
Clear Role and Responsibility Mapping: At study kickoff, define not only what each function does, but also how responsibilities intersect and where dependencies or escalation pathways lie.
Face-to-Face Kickoffs (When Possible): Physical meetings foster real human connection, accelerate understanding, and reduce cycles of misunderstanding. When in-person is not achievable, ensure every remote participant is visibly present and engaged.
Transparency and Recognition: Encourage honest admissions when something is not known and make a point to recognize achievements and efforts, not just errors or shortfalls.
Continuous Alignment Checks: Institute regular review points to revisit priorities, assess progress, and update responsibilities as teams evolve or personnel change.
Inclusive Communication: Recognize behavioral and personality differences; tailor engagement strategies for team members who may be junior, introverted, or less forthcoming.
These communication principles are foundational to any effective clinical trial outsourcing model, enabling not just efficiency but a culture of trust and mutual respect.
Common Pitfalls Leading to Trial Delays: Lessons from Real-World Sponsor–CRO Partnerships
When asked directly about the primary causes of clinical trial delays or failures to initiate on time, Kimberly Guedes is unequivocal: it often comes down to neglected conversations and unchecked assumptions.
Main issues observed include:
Underestimating Site Contracting Timelines: Especially with academic centres in rare disease trials, failure to appreciate or communicate the likely duration for contracts and budgets creates a domino effect of delays.
Misaligned Data or Protocol Expectations: Attempting to implement unrealistic database builds or collect unattainable types of data without discussing feasibility with partners leads to rework.
Failure to Surface Stakeholder Constraints: If stakeholders are not encouraged to voice limitations or operational barriers early, project plans will nearly always suffer from unanticipated slippage.
Practical governance in these relationships is key. Kimberly Guedes advocates for explicit escalation pathways—not as a punitive tool, but as a mechanism to ensure timely decision-making when the study is at risk of stalling.
Navigating Difficult CRO or Vendor Relationships: When to Course Correct
Clinical trial outsourcing models require adaptive, resilient sponsor–CRO relationships. But as experienced leaders know, a partner may repeatedly miss commitments despite productive-seeming meetings and engagement.
Armin asked directly: where’s the line between “keep trying” and an outright partner change?
Kimberly Guedes reflects:
Changing Vendors Is Costly: Replacing a CRO or vendor comes with significant direct costs and timeline risks; it should be a last resort after escalation has failed.
Escalate Appropriately: Engage higher-level contacts (e.g., C-suite or business development leads) if necessary to get attention on persistent issues.
Consider Tolerance and Timeline: Ultimately, the decision point depends on your personal comfort with risk and the study’s critical timelines.
The lesson: Proactive, decisive escalation is preferable to defaulting to a vendor swap—which, while sometimes necessary, should never be taken lightly.
Keeping Teams Aligned in a Hybrid or Remote Environment
With the clinical research industry shifting towards hybrid and remote working models, maintaining engagement and operational focus is an increasing challenge.
The panel shared practical solutions:
Demand Camera Engagement: For remote meetings, seeing faces is non-negotiable for true engagement.
Explicit Meeting Objectives: At the start of each meeting, clarify how each attendee will benefit, appeal directly for focused participation, and discourage multitasking.
Respect for Individual Priorities: Recognise the human aspects of colleagues' lives. Small personal check-ins or informal conversations can go a long way towards building trust and morale.
Keep Meetings Meaningful: Only hold meetings worth people’s time—outline the aim, avoid dragging on, and insist on everyone’s presence when they’re needed.
The operational message: engagement and inclusivity remain as important—and challenging—in a virtual setting as they are in person.
What This Means in Practice
At study start, invest in a structured, comprehensive stakeholder mapping session to clarify responsibilities, escalation processes, and dependencies.
Proactively schedule regular review points for continuous alignment, especially as teams or partners change.
At kickoff and beyond, openly solicit input on operational bottlenecks and surface constraints before final protocols or timelines are set.
Avoid adversarial “us vs. them” thinking; invest in building rapport, recognizing contributions, and treating all parties as integrated members of the trial team.
Be intentional in remote engagement—use cameras, discourage multitasking, and clarify meeting objectives.
Don’t delay escalation when recurrent issues arise with vendors or CROs: act early and escalate to decision-makers.
Recognise and support junior or less experienced staff through tailored communication and opportunities to contribute ideas.
Key Takeaways
Early, honest stakeholder engagement is essential for preventing delays and rework in clinical trial outsourcing.
Operational clarity—through clear roles, responsibilities, and escalation pathways—significantly reduces trial risk.
Continual review and flexibility are central to overcoming unforeseen project challenges and personnel changes.
Escalate and address persistent CRO or vendor issues promptly; swapping partners should be a considered last resort.
Human connection, whether in-person or virtual, remains critical for engagement, motivation, and operational success.
Selected Quotes
“If I know your constraints, then I can deal with that, but I don’t want to find out about your constraints after the fact.” — Kimberly Guedes
“Changing your partner is costly… I would prefer to work something out and it may be escalating it higher than the team that you’re already at… But think hard about changing. I’m not saying don’t do it, I’ve had to do it in the past. But see what other remedies and go higher.” — Kimberly Guedes
“Everyone wants to feel like they are part of something and we need to let people feel that way. We need to empower that. People need to own their own piece of the project.” — Kimberly Guedes
“The biggest communication problem is we do not listen to understand, we listen to reply. And when you leave here, I want you to listen… truly listen to what they’re saying.” — Kimberly Guedes
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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