Flexibility by Design: Rethinking hybrid models for today’s trials with Bianca Fajardo

Discover how to move beyond inherited outsourcing templates and intentionally design operational models that fit your trial’s priorities, improving speed, oversight, and cost control in clinical operations.

GuestBianca FajardoDirector of Clinical Operations, Functional Services Group, Premier ResearchLinkedIn

Episode OverviewRecorded live at COG New England, this session features Bianca Fajardo, Director of Clinical Operations at Premier Research, sharing high-value insights into clinical trial outsourcing decisions and the shift toward more tailored operational models. Drawing on over two decades in the field, Fajardo addresses a key operational challenge: most sponsor organizations inherit legacy outsourcing models instead of designing them to fit evolving trial needs.

The discussion walks through practical frameworks for clinical outsourcing - from leveraging the RFP process as a design dialogue rather than a simple price exercise, to using a “soundboard” approach to weigh competing priorities like speed, cost, oversight, and geography. Bianca presents real-world examples of hybrid delivery in action, highlighting trade-offs and how to architect models that flex with program needs.

Designed for professionals managing clinical trial outsourcing, vendor management, and CRO selection, this session offers concrete best practices that can be implemented across sponsor, CRO, and clinical service teams. Whether you work on study startup, country/site activation, or portfolio-level oversight, you'll find operational strategies for clinical study optimization that are focused, actionable, and relevant amid growing complexity and new technology adoption.

Key Moments00:02:21 – Why most clinical teams default to legacy outsourcing models instead of intentional design

00:04:00 – The role of organizational habit and RFP constraints in narrowing outsourcing options

00:05:29 – Soundboard analogy: how to tune operational models for speed, cost, oversight, capacity, and geography

00:06:44 – When and why to prioritize speed, cost control, or scientific oversight during clinical trial vendor selection

00:09:39 – Moving from selecting predefined models to assembling customized hybrid solutions

00:10:40 – The importance of sponsor self-reflection before entering the RFP process for clinical outsourcing

00:13:01 – Reframing the RFP as a design conversation to co-create an operating model with your CRO