The COG Review: Building Better Clinical Studies

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

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

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

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

Designing Clinical Trials to Avoid Historical Failures in HR-MDS with Joab Wiliamson

Gain practical strategies to de-risk clinical trial outsourcing and design more robust studies in high-risk myelodysplastic syndrome (HR-MDS), with lessons directly applicable to clinical study optimization and CRO selection. SPEAKER * Joab Williamson * VP of Operations, Faron Pharmaceuticals * LinkedIn: Joab Williamson [https://www.linkedin.com/in/joabwilliamson/] * Specialty: Clinical trial operations, immunotherapy development, rare and high-risk oncology indications EPISODE OVERVIEW Live from COG UK, this episode features Joab Williamson, VP of Operations at Faron Pharmaceuticals, sharing an operational case study on trial design and outsourcing strategy for high-risk myelodysplastic syndrome (MDS). The session was moderated by Sverre Bengtsson with insights relevant to those involved in clinical study optimization, CRO selection, and risk mitigation in oncology trials. Drawing from a series of historical failures by leading sponsors in HR-MDS, including studies by Novartis, Takeda, and Gilead, Joab Williamson dissects why promising assets stumbled at the Phase 3 stage, and what clinical operations teams can do differently. Topics include the impact of post-trial treatment and global standard-of-care variability on overall survival endpoints, and why realistic effect sizing plus adaptive design are crucial for clinical outsourcing success. Key operational themes include designing protocols that anticipate real-world patient heterogeneity, aligning geography and eligibility criteria to de-risk outsourcing initiatives, and embedding a pre-mortem approach during early protocol development. For clinical research professionals focused on clinical trial outsourcing, vendor management, and CRO partnerships, the discussion offers actionable frameworks for reducing failure risk and optimizing trial delivery. KEY MOMENTS 00:02:05 – Joab Williamson outlines Faron’s clinical-stage focus and unique challenges in HR-MDS trial execution 00:04:17 – Review of repeated industry failures by large sponsors, and how small biotechs can lead by learning from these in outsourcing contexts 00:05:10 – Why post-trial treatment switching flattens survival signals and requires careful protocol design for accurate CRO performance metrics 00:08:09 – The operational risk of “all-comer” Phase 3 studies and how poor eligibility criteria complicate CRO selection and site management 00:09:06 – Managing global trial execution challenges: how regional standard-of-care differences impact clinical outsourcing outcomes 00:10:07 – Adaptive trial designs for incremental gains: why better statistical planning can rescue studies often lost to underpowered sample sizes 00:11:25 – The critical role of eligibility criteria in optimizing clinical study results and operational feasibility 00:13:02 – Being realistic about effect size and aligning Phase 3 expectations with Phase 1/2 outcomes to mitigate outsourcing and CRO delivery risk 00:14:16 – Leveraging biomarker stratification and operational controls to increase audit-readiness and consistency across outsourced studies 00:18:03 – Practical steps for embedding a pre-mortem analysis into early outsourcing and protocol design phases TOP 3 TAKEAWAYS * Prioritize Realistic Effect Sizing: Don’t overestimate Phase 3 outcomes based on early data, size trials and set outsourcing expectations using conservative, data-driven assumptions and iterative analysis. * Embed Pre-Mortem Reviews in Outsourcing Workflows: Systematically review past failures to guide protocol and vendor selection, reducing repeat errors and optimizing clinical study outcomes with new or existing CROs. * Control Patient and Geographic Variables: Tighten eligibility criteria and align region/site selection with Phase 1/2 success to avoid operational pitfalls and ensure consistent execution across clinical outsourcing partners. LINKS & RESOURCES * The PBC Group – COG Event Series [https://thepbcgroup.com/]: Agendas, blog, and further clinical operations content * Faron Pharmaceuticals [https://www.faron.com/] * Peer-Reviewed Analysis (Faron with Yale): [https://www.researchgate.net/publication/401377745_Learning_from_late-stage_trial_failures_in_higher-risk_myelodysplastic_syndromes_towards_adaptive_and_biomarker-enriched_designs] Published findings on clinical trial design in HR-MDS QUOTES “Look at every single past failure in your indication. When you collect them, you see clear patterns, both in sponsor strategy and in trial design decisions that also directly impact CRO selection and outsourcing outcomes.” - Joab Williamson “A full label isn’t as valuable as a successful trial. Trying to do everything in one study often introduces risk and dilutes clinical operations best practices.” - Joab Williamson “A resizing event in the middle of a Phase 3 allows you to build for success, especially when you’re uncertain of treatment effect or resourcing with an external partner.” - Joab Williamson “There’s a graveyard in high-risk MDS. But if you’re operationally rigorous and realistic in the assumptions you send out to your CROs, it is possible to win.” - Joab Williamson “Designing trials for predictable, incremental gains, with protocol features such as adaptive design and hierarchy of endpoints, delivers both clinical and outsourcing resilience.” - Joab Williamson ----------- 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