Couverture de The COG Review: Building Better Clinical Studies

The COG Review: Building Better Clinical Studies

The COG Review: Building Better Clinical Studies

De : The PBC Group
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This podcast is specifically designed for biopharma sponsors and CRO executives who are interested in clinical trial outsourcing. The COG Review delivers clinical operations best practices from Clinical Outsourcing Group conferences across the UK, Europe, and North America. Each 25-minute episode provides actionable insights on CRO selection, vendor management, clinical trial budget optimization, and study design from pharmaceutical and biotech leaders. Learn clinical trial technology strategies, AI integration, and sponsor-CRO relationship best practices from industry experts at COG UK, COG Europe, COG Bay Area, and COG CRO Summit. Essential listening for clinical operations professionals, biotech CMOs, and clinical development executives seeking clinical study optimization strategies. Produced by The PBC Group. Follow for new episodes and find your nearest meeting at thepbcgroup.com.Copyright 2026 The PBC Group Economie Hygiène et vie saine Maladie et pathologies physiques Management Management et direction Science
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  • 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
    Jun 30 2026
    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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    27 min
  • How To Build Trust and Engage Patients in African Clinical Trials with Dr Sam Mbunya

    How To Build Trust and Engage Patients in African Clinical Trials with Dr Sam Mbunya
    Jun 16 2026
    Discover how global sponsors and CROs can optimize clinical trial outsourcing and patient engagement in Africa by addressing cultural, operational, and regulatory complexities from day one.GuestDr. Sam MbunyaGlobal Patient Advocate; Consultant in Patient Education, Advocacy & Program Management Focus: Sickle cell disease, hemophilia, rare blood disorders, and cancer in African regions Based in Malmö, Sweden; Active in global project collaborations (US, Kenya, African universities)Episode OverviewThis session, recorded live at COG Nordics, features a practical fireside chat with Dr. Sam Mbunya—an experienced patient advocate and program consultant—exploring the real-world nuances of launching and sustaining clinical trial operations in Africa. The discussion moves beyond broad generalizations, highlighting how local context, community trust, and operational diligence are critical in clinical trial outsourcing and CRO selection for African sites.Key topics include the operational and cultural barriers sponsors often overlook, such as health literacy, transport, family decision dynamics, and the legacy of previous studies. Dr. Mbunya outlines best practices for early and ongoing engagement with patient groups, community leaders, and local health systems, emphasizing why these steps are essential for both participant protection and long-term study viability.Listeners working in clinical operations, clinical trial outsourcing, and CRO/vendor management will find actionable strategies for designing studies that respect local realities. The conversation also explores how partnerships, clear communication, and data stewardship can help sponsors and CROs avoid common pitfalls and deliver on inclusion goals—turning compliance into true community impact and clinical study optimization.Key Moments00:00:20 – Why Africa is not a single trial environment and the operational impact of country and community diversity00:02:53 – The health literacy gap: How poor understanding of diseases and research affects trial recruitment and retention00:04:21 – Patient “hope” vs. informed participation: Why transparent communication matters in clinical trial outsourcing settings00:06:03 – Addressing practical barriers such as transport, family dynamics, and cultural decision-making during CRO selection and protocol development00:08:02 – The pitfalls of a “one size fits all” approach: Communicating and customizing study materials for multilingual, multicultural settings00:10:09 – The importance of engagement after negative outcomes: Building trust and credibility post-trial, not just during recruitment00:12:44 – Distinguishing participants from implementers: How involving patients from the outset improves both feasibility and ethical compliance00:16:25 – Regulatory maturity and bottlenecks: Strategies to work with local and national ethics boards for timeline and approval optimization00:18:09 – Leveraging technology and patient advocates for scalable education and improved health literacy00:20:02 – The role of roundtables, advisory councils, and WhatsApp groups in ongoing community dialogue and study support00:26:04 – Top three challenges for sponsors: Open-minded protocol design, governmental engagement, and robust data stewardshipTop 3 TakeawaysPrioritize Early Engagement with Local Stakeholders - Integrate patient groups, community leaders, and local systems into study design and CRO selection processes well before recruitment begins to ensure buy-in, accurate feasibility, and operational alignment.Invest in Health Literacy and Culturally Relevant Communication - Optimize study materials and participant discussions for language, tradition, and educational context—driving true understanding, reducing risk, and strengthening clinical operations best practices.Treat Regulatory and Data Strategies as Core Pillars, Not Afterthoughts - Engage proactively with national authorities and invest in transparent, locally tailored data management to streamline approvals, foster trust, and enable long-term clinical study optimization at new sites.Links & ResourcesThe PBC Group – COG Series Events & ResourcesClinicalTrials.gov – African Trial Registry SnapshotProject ECHO – All Teach, All Learn PlatformWHO – Guidance for Good Clinical Practice in AfricaQuotes“Have an open-minded approach where you look at how people live, listen to their challenges, and engage government and patient advocacy groups from the protocol stage, not after.” – Dr. Sam Mbunya“It’s not just about recruiting fast—it’s about protecting participants, building trust, and ensuring the process starts with patients and families, not just ends with them.” – Dr. Sam Mbunya“Data protection and ownership are critical—robust registries and transparent practices help optimize clinical trial outsourcing and build credibility.”“There’s always this backdrop that the global north puts Africa as a one size fits all ...
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    29 min
  • Direct Clinical Trial Management: Practical Approaches to CRO Selection and Clinical Outsourcing for Lean Biotech Teams with Antonio Bermejo Gomez

    Direct Clinical Trial Management: Practical Approaches to CRO Selection and Clinical Outsourcing for Lean Biotech Teams with Antonio Bermejo Gomez
    Jun 2 2026
    Unlock best practices for sponsor-led decision-making in clinical trial outsourcing, with real-world insight into optimizing CRO selection, partnership models, and operational efficiency, straight from a lean biotech team navigating these choices under budget and time constraints.GuestAntonio Bermejo Gomez, Chief Development Officer, SynartroOperational leader at a Swedish clinical-stage biotech, hands-on with direct sponsor oversight, CRO/vendor selection, and clinical trial deliveryLinkedIn: Antonio Bermejo GomezModerator: Sverre Bengtsson, Clinical Trials AdvisorEpisode OverviewRecorded live at COG Nordics, this focused session features Antonio Bermejo Gomez, Chief Development Officer at Synartro, sharing a sponsor’s perspective on direct clinical trial management. The discussion, guided by David Jones and Sverre Bengtsson, centers on how very small biotech organizations can retain control, make more agile decisions, and achieve clinical study optimization even with limited team size and resources.This episode addresses the core of clinical trial outsourcing: how to maximize operational efficiency, preserve sponsor accountability, and adapt CRO selection frameworks for niche or highly constrained environments. Antonio Bermejo Gomez breaks down real-world strategies for working with specialized consultants, defining sponsor versus CRO responsibilities, and ensuring transparent decision ownership throughout a trial’s lifecycle.Listeners will hear practical insights on:Structuring lean teams to optimize clinical operations without traditional full-service CRO partnershipsBalancing the roles of independent consultants, vendor partners, and in-house expertiseCritical considerations in CRO and CDMO selection when project fit and operational transparency are business-criticalProfessionals involved in CRO selection, clinical outsourcing strategy, or day-to-day study delivery will find actionable perspectives and frameworks to apply in their own clinical operations best practices.Key Moments00:02:39 – The realities of running clinical operations with only two core sponsor staff, emphasizing strict budget control and constrained capital 00:04:47 – Key principle: Sponsor dependence on external partners demands robust clinical outsourcing strategies and clear delegation 00:10:03 – Communication and transparency: Why honest dialogue between sponsor leadership and consultants is essential for small, resource-limited biotechs 00:11:16 – Decision ownership: The sponsor, not external consultants, must make and stand by major study decisions for full accountability 00:13:41 – Clinical trial delivery model: Weekly operational meetings with CRO; continuous sponsor oversight even when lacking direct experience 00:15:02 – Accelerating timelines: How a transparent, focused approach enabled rapid recruitment and completion, delivering the full trial in just seven months 00:16:49 – “Focus on what not to do”: Prioritization as the driver of clinical study optimization under budget and time pressures 00:17:12 – CRO selection lessons: Honest assessment and fit over promises, why first conversations should clarify expectations and capabilities from both sides 00:18:49 – Adaptability: Navigating late-stage process changes (e.g., syringe manufacturing) through cross-functional collaboration among sponsor, CRO, and regulators 00:22:24 – Next steps: Preparing for partnership, licensing, or fundraising as a small team based on strong clinical proof pointsTop 3 TakeawaysSponsor ownership of key decisions is fundamental, successful clinical outsourcing models are built on clear accountability, not delegation of strategic calls to CROs or consultants.CRO selection should prioritize honesty, project fit, and early mutual understanding, rather than optimistic capability claims; one wrong outsourcing decision can jeopardize a lean biotech’s entire clinical program.Clinical operations best practices for lean teams include ruthless prioritization, knowing what not to do is as valuable as knowing what to execute, ensuring every action ties directly to data value and milestone delivery.Links & ResourcesThe PBC Group – COG Event Series and BlogSynartro – Company OverviewCOG Nordics – Conference InformationQuotes“The sponsor always needs to be accountable and responsible for all the decisions.” , Antonio Bermejo Gomez“A small team can be very efficient if everyone is comfortable with uncertainty and focused on what really matters for clinical study optimization.”“It’s easy to say the consultant or CRO advised it, but as sponsor you must own the outcome, good or bad.”“In CRO selection, be polite but never pretend during first discussions. You only have one shot, and a mismatch can close down the whole clinical program.”“When you can’t do everything, knowing what not to do, and saying no to the ‘easy path’, is critical for operational efficiency in clinical trial outsourcing.”-------...
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    29 min
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