The COG Review: Building Better Clinical Studies

The Future of Risk Based Quality Management for Early Phase Studies with Duncan Hall

21 min · 31. mar. 2026
episode The Future of Risk Based Quality Management for Early Phase Studies with Duncan Hall cover

Description

Discover how risk-based quality management transforms early phase clinical operations, offers solutions for clinical outsourcing challenges, and enables a more patient-centered approach—so you can optimize your next trial’s quality and efficiency. SPEAKER * Duncan Hall * CEO, TRI * Experienced leader in clinical operations and technology innovation for clinical trials * LinkedIn [https://www.linkedin.com/in/duncanhall2/] EPISODE OVERVIEW Recorded live at COG UK, this episode features Duncan Hall, CEO of TRI, leading a focused session on risk-based quality management (RBQM) for early phase clinical trials. Presented as part of The COG Review: Building Better Clinical Studies by The PBC Group, this discussion is tailored for professionals responsible for clinical trial outsourcing, CRO selection, and operational excellence in global clinical studies. The session tackles how RBQM, when applied from protocol design through central monitoring, can close critical gaps in early phase study oversight. Duncan Hall breaks down why traditional site-by-site analytics don’t fit single-center or low-volume studies—and outlines the need for patient-level data review as an operational best practice. He reveals how technology-enabled workflows, validated systems, and centralized reviews help reduce manual review inefficiency without sacrificing compliance or data integrity. Key topics include RBQM’s regulatory context, practical mechanisms for improving patient safety and data quality, how clinical outsourcing models impact early phase trials, and the considerations for selecting technology solutions that fit the realities of small-scale biotechs. This episode is essential listening for anyone looking to optimize clinical operations and make more informed decisions on CRO selection and clinical trial outsourcing. KEY MOMENTS 00:02:27 – Shifting from routine monitoring to critical, risk-based thinking in protocol design 00:03:33 – Why early phase trials carry more operational risk—and how RBQM addresses it 00:06:05 – Limitations of site-based analytics in early phase studies and implications for clinical outsourcing partners 00:07:14 – Patient-level review as a clinical operations best practice for small or single-center trials 00:08:07 – Compliance challenges posed by manual tools (Excel, email) in clinical study optimization 00:10:24 – Designing technology that prioritizes patient review, streamlines workflow, and reduces repeat effort 00:11:19 – Risks of missed data signals due to inefficient manual review and impact on patient safety 00:12:20 – Aggregating data for holistic review to enable more proactive trial management 00:18:29 – Need for purpose-built technology (not repurposed late-stage tools) in early phase clinical operations 00:19:31 – Measuring quality through protocol adherence, data timeliness, and meaningful data ranges 00:20:12 – Strategies for managing RBQM system costs for biotechs with limited budgets in clinical outsourcing models Top 3 Takeaways 1. Patient-level Data Review: For early phase studies, adopting a patient-centric review model—rather than site-to-site comparison—enhances safety oversight and aligns with RBQM principles, marking a clinical operations best practice. 2. Validated Technology vs. Manual Tools: Relying on spreadsheets and email for clinical study optimization risks non-compliance and inefficiency; purpose-built, validated systems improve both operational outputs and regulatory readiness. 3. Adapt Technology and Pricing: Technology vendors should offer flexible pricing and purpose-designed platforms to enable smaller sponsors and biotechs to implement RBQM without prohibitive costs, supporting better CRO selection and clinical trial outsourcing outcomes. LINKS & RESOURCES * The PBC Group [https://thepbcgroup.com/] – Event agendas, blog, and resources from Clinical Outsourcing Group meetings * ICH E6(R3) Guidance [https://ich.org/page/efficacy-guidelines] – Latest regulatory guidance on GCP and RBQM * TRI [https://www.tritrials.com/] – TRI company site and technology solutions for clinical trials QUOTES "RBQM starts at protocol design, not at monitoring visits—critical thinking up front drives quality throughout the study lifecycle." – Duncan Hall "Early phase is where the risks are highest, but site-by-site analytic models don’t add value; patient-level focus is needed for operational efficiency." – Duncan Hall "Validated technology, audit trails, and access control are now mandated by GCP—Excel and email just aren’t fit for clinical study optimization anymore." – Duncan Hall "The cost of manual, low-value checking is high and unsustainable. Technology should enable smarter reviews, not repeat the same work." – Duncan Hall "We always work with companies to tailor pricing; the goal is to partner early and roll successful approaches into larger trials in the future." – Duncan Hall Further content and agendas: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] ----------- Further content and agendas: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] Copyright 2026 The PBC Group

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16 episodes

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

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. GUEST * Bianca Fajardo * Director of Clinical Operations, Functional Services Group, Premier Research * LinkedIn [https://www.linkedin.com/in/bianca-fajardo-09483499/] EPISODE OVERVIEW Recorded 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 MOMENTS 00:02:21 – 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 00:14:24 – Concrete examples: modular and region-specific hybrid models for global clinical studies 00:18:42 – Mitigating added complexity in hybrid outsourcing models through proactive coordination and clear oversight 00:24:35 – Why strong partnership, transparency, and upfront collaboration set clinical trials up for success TOP 3 TAKEAWAYS 1. Intentional Design Drives Value 2. The 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. 3. Transform the RFP Process 4. Use 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. 5. Hybrid Doesn’t Mean Complicated—If Well-Structured 6. A 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 & RESOURCES * COG Event Series and Agenda [https://thepbcgroup.com/] * Explore upcoming meetings, curated session line-ups, and global events for clinical operations and outsourcing leaders. * Premier Research [https://premier-research.com/] * Information on clinical operations, functional service provision, and partnership models. * COG Blog: CRO Selection and Clinical Outsourcing Playbooks [https://thepbcgroup.com/blog] * Articles 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: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] ----------- Further content and agendas: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] Copyright 2026 The PBC Group

30. juni 202626 min
episode How To Build Trust and Engage Patients in African Clinical Trials with Dr Sam Mbunya artwork

How To Build Trust and Engage Patients in African Clinical Trials with Dr Sam Mbunya

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. GUEST * Dr. Sam Mbunya [https://www.linkedin.com/in/dr-mbunya-s-misiani-dba-b3a69799/] * Global 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 OVERVIEW This 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 MOMENTS 00:00:20 – Why Africa is not a single trial environment and the operational impact of country and community diversity 00:02:53 – The health literacy gap: How poor understanding of diseases and research affects trial recruitment and retention 00:04:21 – Patient “hope” vs. informed participation: Why transparent communication matters in clinical trial outsourcing settings 00:06:03 – Addressing practical barriers such as transport, family dynamics, and cultural decision-making during CRO selection and protocol development 00:08:02 – The pitfalls of a “one size fits all” approach: Communicating and customizing study materials for multilingual, multicultural settings 00:10:09 – The importance of engagement after negative outcomes: Building trust and credibility post-trial, not just during recruitment 00:12:44 – Distinguishing participants from implementers: How involving patients from the outset improves both feasibility and ethical compliance 00:16:25 – Regulatory maturity and bottlenecks: Strategies to work with local and national ethics boards for timeline and approval optimization 00:18:09 – Leveraging technology and patient advocates for scalable education and improved health literacy 00:20:02 – The role of roundtables, advisory councils, and WhatsApp groups in ongoing community dialogue and study support 00:26:04 – Top three challenges for sponsors: Open-minded protocol design, governmental engagement, and robust data stewardship TOP 3 TAKEAWAYS * Prioritize 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 & RESOURCES * The PBC Group – COG Series Events & Resources [https://thepbcgroup.com/] * ClinicalTrials.gov – African Trial Registry Snapshot [https://clinicaltrials.gov/] * Project ECHO – All Teach, All Learn Platform [https://hsc.unm.edu/echo/] * WHO – Guidance for Good Clinical Practice in Africa [https://www.who.int/publications/i/item/9789240026176] QUOTES “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 project; but the dynamics, language, and context require a fundamentally different operational approach.” ----------- Further content and agendas: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] Copyright 2026 The PBC Group

16. juni 202628 min
episode Direct Clinical Trial Management: Practical Approaches to CRO Selection and Clinical Outsourcing for Lean Biotech Teams with Antonio Bermejo Gomez artwork

Direct Clinical Trial Management: Practical Approaches to CRO Selection and Clinical Outsourcing for Lean Biotech Teams with Antonio Bermejo Gomez

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. GUEST * Antonio Bermejo Gomez, Chief Development Officer, Synartro * Operational leader at a Swedish clinical-stage biotech, hands-on with direct sponsor oversight, CRO/vendor selection, and clinical trial delivery * LinkedIn: Antonio Bermejo Gomez [https://www.linkedin.com/in/antonio-bermejo-g%C3%B3mez-05203445/] * Moderator: Sverre Bengtsson, Clinical Trials Advisor EPISODE OVERVIEW Recorded 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 partnerships * Balancing the roles of independent consultants, vendor partners, and in-house expertise * Critical considerations in CRO and CDMO selection when project fit and operational transparency are business-critical Professionals 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 MOMENTS 00:02:39 – 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 points TOP 3 TAKEAWAYS 1. Sponsor ownership of key decisions is fundamental, successful clinical outsourcing models are built on clear accountability, not delegation of strategic calls to CROs or consultants. 2. 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. 3. 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 & RESOURCES * The PBC Group – COG Event Series and Blog [https://thepbcgroup.com/] * Synartro – Company Overview [https://synartro.com/] * COG Nordics – Conference Information [https://thepbcgroup.com/cog-nordics/] QUOTES “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.” ----------- Further content and agendas: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] Copyright 2026 The PBC Group

2. juni 202628 min
episode Strategic CRO Selection & Vendor Partnerships: Real-World Approaches for Emerging Biopharma artwork

Strategic CRO Selection & Vendor Partnerships: Real-World Approaches for Emerging Biopharma

Learn practical strategies and insights from experts on how to outsource clinical trials and choose CROs, aimed at helping clinical operations leaders improve study execution and strengthen relationships with vendors. SPEAKERS * Nara Daubany – CEO & Co-Founder, Phaim Pharma [https://uk.linkedin.com/in/nara-daubeney] * Graeme Duncan – Head of Clinical Development, Neurocentrix [https://uk.linkedin.com/in/graeme-duncan-584b75b] * Claire Herholdt – VP Clinical Operations, Levicept [https://uk.linkedin.com/in/claire-herholdt-7356b316] * Bradley Norton – VP Clinical Operations, Gylden Pharma [https://uk.linkedin.com/in/bradley-norton-017819a] * Sarah Whalley – Director Clinical Operations, Uploid Biotechnologies [https://www.linkedin.com/posts/u-ploid-biotechnologies_coguk-clinicaloperations-biotech-activity-7429174965834448896-1ODY] * Deirdre Flaherty – VP Product Strategy & Clinical Operations, Alchemab Therapeutics [https://uk.linkedin.com/in/deirdreflaherty] * Julia Vassiliadou – VP Clinical Operations, F2G [https://uk.linkedin.com/in/julia-vassiliadou] EPISODE OVERVIEW Recorded live at COG UK, this panel brings together senior clinical operations leaders from emerging biopharma and specialty biotech companies to share their operational realities, decision frameworks, and lessons learned in clinical trial outsourcing and CRO selection. Panelists reveal how small, lean teams evaluate CRO fit beyond price, integrating clinical operations best practices to ensure continuity, ownership, and transparency throughout the study lifecycle. The discussion examines differences in working with small- and mid-sized CROs versus the Big Five providers, including non-negotiables in vendor selection and the impact of global studies on CRO partnership decisions. Key questions addressed include: * How do sponsors prioritize CRO selection criteria beyond cost? * What practical signals indicate a CRO’s operational capacity, therapeutic expertise, and partnership mindset? * How do sponsors manage global clinical outsourcing, regional complexity, and adapt outsourcing models for rare disease, vaccines, or novel therapeutic areas? The session offers a real-world look at study startup, site activation, patient recruitment, and the evolving landscape of sponsor, vendor collaboration, all with a focus on clinical study optimization and actionable takeaways for operations, outsourcing, and stakeholder teams. KEY MOMENTS 00:01:49 – Defining the scope: clinical trial outsourcing, vendor fit, and operational efficiency 00:09:18 – Key decision levers for study location and CRO selection, balancing funding, patient access, and regulatory challenges 00:12:18 – Sponsor “killer questions” for CROs: assessing experience, partnership, and project de-risking 00:13:29 – Site selection frameworks: the role of specialty CROs in pain and OA studies, evidence-based site/country choice 00:14:43 – Global partnerships for vaccine trials: aligning CRO selection with endemic regions and collaborative partners 00:17:29 – Rare disease clinical outsourcing: CRO global presence, therapeutic expertise, and sponsor oversight 00:21:10 – Fitting the CRO model to novel, non-traditional clinical trial designs (e.g., IVF, women’s health) 00:24:31 – Weighing small/mid-sized versus large CROs: sponsor risk, project fit, and operational agility 00:27:28 – Sponsor oversight with large CROs: importance of clear communication, consistency, and global reach 00:29:12 – Transparency and adaptive CRO selection across study phases and pivotal trials 00:31:33 – Risk-sharing and creative contracting: milestone payments, outsourcing models, and sponsor independence 00:34:34 – Panel’s “non-negotiables”: continuity, ownership, proactive risk management, and transparent relationships TOP 3 TAKEAWAYS * Deep partnership matters more than price in CRO selection. Sponsors should prioritize operational fit, core team continuity, and shared ownership for clinical study optimization. * Clinical trial outsourcing models are not one-size-fits-all. Consider therapeutic complexity, geographical spread, internal capabilities, and need for oversight when choosing between small, mid-sized, or global CROs. * Early, collaborative protocol engagement with CROs reduces downstream amendments and fosters sponsor–vendor alignment, empowering teams to manage risk and accelerate delivery. LINKS & RESOURCES * The PBC Group – Clinical Outsourcing Group events [https://thepbcgroup.com/clinical-outsourcing-group] * Phaim Pharma [https://www.phaim.co.uk/] * Neurocentrix [https://www.neurocentrx.com/] * Levicept [https://levicept.com/] * Gylden Pharma [https://www.gyldenpharma.com/] * Uploid Biotechnologies [https://www.u-ploid.com/] * Alchemab Therapeutics [https://www.alchemab.com/] * F2G [https://f2g.com/] QUOTES “Fit when they come into the room in that bid defense means a lot. Your ability as a small team to know that you can work with this other group of people collaboratively—that partnership is built through paper as well as formal interactions.” – Deirdre Flaherty “The traditional setup of the biggest CROs… the worse your project is doing, the more money they make. If you have to add sites or amend, it translates into more cost. That’s untenable for small biotechs.” – Claire Herholdt “The non-negotiable is the core team assigned to the project. My expectation is during award, that person remains on the study throughout.” – Graeme Duncan “For rare disease, every patient counts. We needed a CRO with global presence and proven therapeutic expertise, plus strong sponsor oversight.” – Julia Vassiliadou “It’s rarely cost. What matters to our investors is how fast you can get to a value inflection—how quickly you can get data. All those factors roll into what we want in a CRO partner.” – Deirdre Flaherty ----------- Further content and agendas: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] ----------- Further content and agendas: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] Copyright 2026 The PBC Group

12. maj 202638 min
episode The State of Clinical Trial Outsourcing in the UK: Optimizing Site Selection, Resources, and Performance artwork

The State of Clinical Trial Outsourcing in the UK: Optimizing Site Selection, Resources, and Performance

Hear leading UK clinical operations experts tackle today’s most critical challenges in clinical trial outsourcing, CRO selection, and site optimization—insight essential for any trial leader planning or delivering studies across the UK and global markets. SPEAKERS * Moderator: Sverre Bengtsson [https://www.linkedin.com/in/sverrebengtsson/] * Fiona Shields, Head of UK Clinical Operations, Novartis [https://uk.linkedin.com/in/fiona-shields-3206ba47] * Divya Chadha Manek, Director of Clinical Operations, EyeBio [https://uk.linkedin.com/in/divya-chadha-manek-obe-00b56182] * Suki Balendra , Director of Strategic Partnerships, Paddington Life Sciences [https://uk.linkedin.com/in/sukibalendraphd] * Lucy Clossick Thomson , Head of Clinical Operations, Purespring Therapeutics [https://uk.linkedin.com/in/lucy-clossick-thomson-6597527] * Sarah Dealey, Director of Country & Site Operations, Biogen [https://uk.linkedin.com/in/sarah-deeley-140a111b] * Janette Rawlinson , Patient Advocate and Research Partner, Various national/international patient organizations [https://uk.linkedin.com/in/janetterawlinson] EPISODE OVERVIEW This episode features a candid panel discussion recorded live at COG UK. Senior clinical operations leaders from industry, biotech, NHS, and patient advocacy discuss the evolving landscape of clinical research in the UK, with direct implications for clinical trial outsourcing, CRO selection, and study delivery optimization. The panel explores why, despite a growing number of clinical trials, recruitment rates are falling and UK sites are receiving lower enrollment allocations. Experts dissect how conservative site targets, performance metrics, and resource constraints are impacting site selection decisions and sponsor strategies - a topic critical for clinical operations, outsourcing, and vendor management professionals handling global studies. Key areas include how to build more resilient and accountable sponsor–site partnerships, approaches to decentralizing trial delivery, tailoring CRO selection and outsourcing models to increase reliability, and deploying operational best practices that enable faster site activation, improved patient recruitment, and consistent protocol delivery. Patient advocacy and the unique role of NHS/industry collaboration also feature prominently, offering perspectives on how to bridge structural gaps and better utilize the UK’s world-class data sets and patient diversity for clinical study optimization. KEY MOMENTS * 00:02 – UK clinical trial landscape: why are trial numbers up while patient recruitment falls? * 00:04 – How conservative site targets and accountability metrics created a downward cycle in UK site enrollment * 00:06 – Industry and NHS perspectives: site reliability, consistency, and the barriers to delivering clinical trial outsourcing at scale * 00:09 – Site activation delays, site resourcing challenges, and why “winner” sites dominate CRO selection * 00:12 – The role of site resources: how local limitations shape CRO/vendor selection and operational risk * 00:14 – Linking UK’s data resources to clinical operations: innovative models and the potential for pre-screened “virtual waiting rooms” * 00:15 – Cross-department bottlenecks in the NHS: pharmacy, imaging, IT, and their impact on sponsor/outsourcing models * 00:20 – Accountability frameworks: how stronger governance and direct engagement are reshaping site and sponsor performance * 00:25 – Public vs. private sites: operational differences, business-model thinking, and implications for clinical trial outsourcing strategy * 00:34 – Phase 2/3 trial expansion and later-phase access, but persistent resource and recruitment hurdles * 00:37 – Global benchmarking: incentives in Germany, site performance metrics (e.g. CRDCs), and lessons for UK outsourcing TOP 3 TAKEAWAYS 1. Site Selection and CRO Selection Must Go Beyond Track Record: 2. Both industry and patient advocates agree, defaulting to the same high-recruiting “winner” sites creates systemic access barriers. Effective clinical trial outsourcing requires nuanced CRO selection and site engagement to widen participation while balancing quality and speed. 3. Operational Resource Gaps Drive Underperformance: 4. Resource and cross-functional support deficits (in pharmacy, imaging, IT) are major blockers to timely site activation and successful outsourcing outcomes. Top-performing sites, public or private, function with strong business-like governance and clear lines of accountability. 5. Collaboration and Accountability Are Key to Clinical Study Optimization: 6. Breakthroughs in UK delivery now hinge on true partnership: flexible, site-by-site support models; integrated data utilization; transparent performance measures; and shared responsibility among sponsor, site, and CRO. This is the path to accelerated timelines and sustainable clinical operations best practices. LINKS & RESOURCES * The PBC Group – Clinical Outsourcing & COG Event Series [https://thepbcgroup.com/] * ABPI: UK Clinical Research Reports [https://www.abpi.org.uk/facts-and-figures/research-and-development/] * NIHR: Clinical Research Delivery Initiatives [https://www.nihr.ac.uk/] * Health Data Research UK [https://www.hdruk.ac.uk/] * Novartis [https://www.novartis.com/] * EyeBio [https://www.baincapitallifesciences.com/portfolio/eyebio] * Paddington Life Sciences [https://www.thisispaddington.com/article/introducing-paddington-life-science-partners] * Purespring Therapeutics [https://purespringtx.com/] * Biogen [https://www.biogen.co.uk/] QUOTES “Conservative site targets and performance metrics have led to sponsors giving UK sites much smaller allocations—the more conservative we are, the less opportunity we get.” — Sarah Dealey “We go to the same sites because they have the expertise and resources, but to unlock UK potential, industry must think outside the box—linking rich data assets to new trial delivery models.” — Fiona Shields “Sites that succeed act like a business: clear accountability, strong timelines, and a customer-focused approach. That’s true globally, not just in the UK.” — Divya Chadha Manek “To make trials truly accessible, we must involve patient advocates deeply—from trial design to targeted outreach—ensuring protocols and trial models fit real patient needs.” — Janette Rawlinson “Accountability and true partnership are what will raise UK performance. Sites and industry must align, with clear expectations and shared responsibility for outcomes.” — Suki Balendra ----------- Further content and agendas: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] ----------- Further content and agendas: h [https://thepbcgroup.com/blog]https://thepbcgroup.com [https://thepbcgroup.com/blog] Copyright 2026 The PBC Group

28. apr. 202643 min