Optimising Stakeholder Engagement: Clinical Trial Outsourcing, CRO Selection, and Delivery Best Practices with Kimberly Guedes

Discover actionable strategies to align incentives, clarify roles, and streamline communication for faster, more predictable clinical trial delivery—essential listening for anyone involved in clinical trial outsourcing, CRO selection, or operational leadership.

Guest

Kimberly Guedes
Vice President, Clinical Operations, Intensity Therapeutics
30+ years’ experience in global drug development across preclinical to Phase IV studies
Leader in process improvement, vendor management, and clinical operations strategy
LinkedIn

Episode Overview

Recorded live at a Clinical Outsourcing Group (COG) Bay Area event and introduced by David Jones, this episode features Kimberly Guedes, VP Clinical Operations at Intensity Therapeutics. In her keynote, Kimberly addresses the operational realities and leadership challenges of optimising stakeholder engagement in clinical trial delivery.

The session offers practical insight into the core factors behind study delays, the importance of early alignment, and communication strategies that underpin successful clinical trial outsourcing programmes. Clinical operations professionals, outsourcing leads, and vendor managers will find a grounded framework for ensuring clarity between sponsors, CROs, service vendors, and research sites.

Topics include:

The dynamics of stakeholder collaboration in clinical outsourcing models
Criteria for effective CRO selection and ongoing governance
Methods for bridging communication gaps and achieving clinical study optimisation
Handling team changes, fostering trust, and responding to practical constraints

This episode is designed for those seeking proven clinical operations best practices to help accelerate timelines, improve outsourcing partnerships, and enhance delivery outcomes.

Key Moments

00:03:20 – Defining stakeholder engagement in the context of clinical trial outsourcing and delivery

00:04:11 – Understanding unique perspectives and constraints of sponsors, CROs, vendors, sites, and patients

00:05:09 – Building predictability and trust through early, honest communication

00:06:54 – Risks of poor engagement: delays, rework, low morale, and project failure

00:08:02 – The importance of joint project planning and cross-functional team training

00:10:03 – Creating a culture of mutual respect, transparency, and recognition with partners

00:12:03 – Establishing clear roles, responsibilities, and governance for effective CRO/vendor partnerships

00:14:56 – The impact of understanding team members' strengths, backgrounds, and communication styles

00:18:16 – Shifting from reactive blame to collaborative problem solving in clinical operations

00:19:26 – Empowering all stakeholders to ask questions and contribute new ideas for study optimisation

00:27:15 – Best practices for engaging remote or distributed teams in clinical outsourcing delivery

Top 3 Takeaways

Initiate open, honest conversations about constraints and expectations early in the outsourcing process to set realistic study timelines and avoid costly delays (CRO selection and clinical trial outsourcing).
Establish—and regularly review—clear roles, responsibilities, and escalation pathways with all stakeholders to drive accountability and ensure effective governance (clinical operations best practices).
Foster ongoing, two-way communication and inclusivity across sponsor, CRO, and site teams, recognising the value of both formal meetings and informal, human connection to enhance engagement and project continuity (clinical study optimisation).

Links & Resources

Intensity Therapeutics

Kimberly Guedes on LinkedIn

Quotes

“We’re all a team and we all have something to gain here and we have a lot to lose here—we build more rapport and trust if we can have honest conversations, even if they’re not always easy.” – Kimberly Guedes

“If you don’t know the constraints of your partners, or the timelines they can realistically deliver, then you’ve failed already—those conversations need to happen before your protocol is even finalised.” – Kimberly Guedes

“It’s not about blame; it’s about how we pick up the ball and work together to get to the end zone—focus on solutions rather than pitfalls.” – Kimberly Guedes

“Being clear in your communications—what needs to be done, by whom, and when—creates predictability and reduces costly rework. Ambiguity is the enemy of timely delivery.” – Kimberly Guedes

“Everyone wants to feel like they are part of something. Empowering sites, participants, CROs, and sponsors—all stakeholders—not only improves retention, it’s the mark of successful clinical outsourcing.” – Kimberly Guedes

-----------

Further content and agendas: hhttps://thepbcgroup.com