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
Épisodes
  • Master Protocols in Rare Disease: Practical Approaches to Basket and Umbrella Trial Design for Clinical Study Optimization with Nerissa Kreher

    Master Protocols in Rare Disease: Practical Approaches to Basket and Umbrella Trial Design for Clinical Study Optimization with Nerissa Kreher
    Jul 14 2026
    Discover the operational frameworks and real-world considerations for implementing basket and umbrella trials in rare disease, enabling faster, more efficient clinical trial outsourcing and improved CRO selection strategies.GuestNerissa Kreher, MD, MBAChief Medical Officer, AlltrnaLinkedInExtensive experience in rare disease drug development, clinical operations leadership, and innovative trial design.Episode OverviewRecorded live at COG New England, this session features Nerissa Kreher, Chief Medical Officer at Alltrna, in conversation with David Jones, Head of Content at The PBC Group. The discussion centers on the application of master protocol designs, basket, umbrella, and platform trials, in optimizing clinical operations for rare disease studies.The episode addresses the persistent challenges in rare disease R&D: small and heterogeneous patient populations, restricted clinical data, and the inherent barriers to traditional country- and site-level trial models. Nerissa Kreher provides clear definitions of trial types and outlines how operational efficiencies and cross-functional collaboration can be achieved through well-structured master protocols, which have seen broad adoption in oncology but remain underused in rare disease.Key topics include the use of shared control arms to reduce patient numbers, leveraging biomarker-defined cohorts for more targeted studies, and real-world applications of innovative trial designs which are shaping new models for clinical trial outsourcing and clinical study optimization. Hear practical frameworks and candid examples, with a focus on what needs to change operationally across sponsors, CROs, and regulatory interfaces to unlock these efficiencies.This session is essential listening for professionals in clinical operations, CRO/vendor management, and clinical development strategy, providing a toolkit for evaluating master protocols and refining CRO selection criteria for rare disease programs.Key Moments00:01:19 – Essential constraints in rare disease: implications for feasibility, trial design, and clinical trial outsourcing00:03:19 – The impact of genotypic and phenotypic heterogeneity on CRO selection and study start-up in rare indications00:05:06 – The case for moving beyond “one trial per disease”: operational inefficiency in traditional models00:06:34 – Clear definitions and trade-offs between platform, basket, and umbrella trial designs for sponsors and CROs00:07:01 – How shared control arms reduce patient burden and streamline clinical study optimization00:09:05 – Underuse of basket trials in rare disease: key barriers and opportunities for innovative clinical outsourcing00:12:18 – Real-world example: efficiently enrolling multiple rare immune-mediated diseases under a single protocol00:14:04 – Framework for umbrella INDs: template-based approaches for rapid therapy development in ultra-rare settings00:18:09 – Statistical and regulatory efficiencies: leveraging concurrent evidence generation and shared INDs00:21:12 – Platform technology designation: implications for vendor partnerships, manufacturing, and regulatory submission efficiency00:26:41 – The need for biomarker validation, cross-functional collaboration, and adaptive design in rare disease clinical operationsTop 3 TakeawaysMaster protocols offer concrete operational efficiencyConverging studies through basket and umbrella designs allows for single INDs, shared sites and data, and streamlined CRO selection, resulting in faster start-up and reduced patient burden across rare diseases.Shared control arms and biomarker-defined groups improve both patient experience and clinical study optimizationPooling patients and endpoints through robust master protocols delivers more statistical power in diseases where sample sizes are inherently limited, driving better outcomes for both sponsors and clinical outsourcing partners.Successful rare disease trials require proactive stakeholder engagementCross-functional collaboration, including patient advocacy, academia, and vendor alignment, is fundamental for effective trial execution, regulatory navigation, and future-facing clinical operations best practices.Links & ResourcesThe PBC Group: Events and Resources Clinical Outsourcing Group meetings, agendas, and content library.NORD: Master Protocols in Rare Disease Systematic reviews and scientific resources on platform and basket trial design.FDA – Platform Technologies for Drug Development Guidance and updates on regulatory innovation relevant to master protocols.Alltrna Biotech Details on emerging tRNA therapies and clinical strategy.Quotes“Aggregating patient populations across shared molecular backgrounds allows for efficiency across every step of drug development.” “If you have a shared control arm instead of multiple for each therapy, you can see how that reduces sample size, and speeds decision making.”“We’re still not utilizing basket trials in rare disease as ...
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    28 min
  • 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
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