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

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

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

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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 ResearchLinkedInEpisode 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 design00:04:00 – The role of organizational habit and RFP constraints in narrowing outsourcing options00:05:29 – Soundboard analogy: how to tune operational models for speed, cost, oversight, capacity, and geography00:06:44 – When and why to prioritize speed, cost control, or scientific oversight during clinical trial vendor selection00:09:39 – Moving from selecting predefined models to assembling customized hybrid solutions00:10:40 – The importance of sponsor self-reflection before entering the RFP process for clinical outsourcing00:13:01 – Reframing the RFP as a design conversation to co-create an operating model with your CRO00:14:24 – Concrete examples: modular and region-specific hybrid models for global clinical studies00:18:42 – Mitigating added complexity in hybrid outsourcing models through proactive coordination and clear oversight00:24:35 – Why strong partnership, transparency, and upfront collaboration set clinical trials up for successTop 3 TakeawaysIntentional Design Drives ValueThe most effective clinical trial outsourcing models are engineered—not inherited. Start by clarifying study priorities, then design the operational mix accordingly rather than defaulting to templates.Transform the RFP ProcessUse the RFP as the foundation for a design conversation, not just a price comparison. Early, candid dialogue about sponsor needs and capabilities leads to better CRO selection and clinical operations best practices.Hybrid Doesn’t Mean Complicated—If Well-StructuredA hybrid approach requires careful up-front planning and partnership but can replace downstream inefficiencies. Matching model components to program realities enables true clinical study optimization.Links & ResourcesCOG Event Series and AgendaExplore upcoming meetings, curated session line-ups, and global events for clinical operations and outsourcing leaders.Premier ResearchInformation on clinical operations, functional service provision, and partnership models.COG Blog: CRO Selection and Clinical Outsourcing PlaybooksArticles and frameworks on clinical trial vendor management, RFP design, and best practices in outsourcing.Quotes“Most often, we think we’re selecting our outsourcing models, but in reality, we’re inheriting them—defaulting to legacy processes and partnerships.” “Instead of asking ‘Which model should we use?’ the better question is ‘What are we optimizing for in this trial?’” “The RFP process shouldn’t just be transactional. It’s the perfect moment to co-create the right operating model with your CRO.” “No single fixed model ever fits every study. Hybrid approaches, when thoughtfully designed, enable us to match operational strategy to our trial’s real needs.” “Strong partnerships and intentional design up front do more to prevent inefficiency and delay than any ready-made template.”-----------Further content and agendas: hhttps://thepbcgroup.com-----------Further content and agendas: hhttps://thepbcgroup.comCopyright 2026 The PBC Group
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