The COG Review: Building Better Clinical Studies

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.

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

    2d ago

    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. 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 Advisor Episode 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-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 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 points Top 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 Information 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: hhttps://thepbcgroup.com Copyright 2026 The PBC Group

    29 min
  2. Strategic CRO Selection & Vendor Partnerships: Real-World Approaches for Emerging Biopharma

    May 12

    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. SpeakersNara Daubany – CEO & Co-Founder, Phaim PharmaGraeme Duncan – Head of Clinical Development, NeurocentrixClaire Herholdt – VP Clinical Operations, LeviceptBradley Norton – VP Clinical Operations, Gylden PharmaSarah Whalley – Director Clinical Operations, Uploid BiotechnologiesDeirdre Flaherty – VP Product Strategy & Clinical Operations, Alchemab TherapeuticsJulia Vassiliadou – VP Clinical Operations, F2G Episode OverviewRecorded 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 Moments00:01:49 – 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 TakeawaysDeep 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 & ResourcesThe PBC Group – Clinical Outsourcing Group eventsPhaim PharmaNeurocentrixLeviceptGylden PharmaUploid BiotechnologiesAlchemab TherapeuticsF2G 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: hhttps://thepbcgroup.com ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group

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

    Apr 28

    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. SpeakersModerator: Sverre BengtssonFiona Shields, Head of UK Clinical Operations, NovartisDivya Chadha Manek, Director of Clinical Operations, EyeBioSuki Balendra , Director of Strategic Partnerships, Paddington Life SciencesLucy Clossick Thomson , Head of Clinical Operations, Purespring TherapeuticsSarah Dealey, Director of Country & Site Operations, BiogenJanette Rawlinson , Patient Advocate and Research Partner, Various national/international patient organizations Episode OverviewThis 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 Moments00:02 – 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 enrollment00:06 – Industry and NHS perspectives: site reliability, consistency, and the barriers to delivering clinical trial outsourcing at scale00:09 – Site activation delays, site resourcing challenges, and why “winner” sites dominate CRO selection00:12 – The role of site resources: how local limitations shape CRO/vendor selection and operational risk00:14 – 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 models00:20 – Accountability frameworks: how stronger governance and direct engagement are reshaping site and sponsor performance00:25 – Public vs. private sites: operational differences, business-model thinking, and implications for clinical trial outsourcing strategy00:34 – Phase 2/3 trial expansion and later-phase access, but persistent resource and recruitment hurdles00:37 – Global benchmarking: incentives in Germany, site performance metrics (e.g. CRDCs), and lessons for UK outsourcing Top 3 TakeawaysSite Selection and CRO Selection Must Go Beyond Track Record: 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.Operational Resource Gaps Drive Underperformance: 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.Collaboration and Accountability Are Key to Clinical Study Optimization: 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 & ResourcesThe PBC Group – Clinical Outsourcing & COG Event SeriesABPI: UK Clinical Research ReportsNIHR: Clinical Research Delivery InitiativesHealth Data Research UKNovartisEyeBioPaddington Life SciencesPurespring TherapeuticsBiogen 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: hhttps://thepbcgroup.com ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group

    43 min
  4. Designing Clinical Trials to Avoid Historical Failures in HR-MDS with Joab Wiliamson

    Apr 14

    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. SpeakerJoab WilliamsonVP of Operations, Faron PharmaceuticalsLinkedIn: Joab WilliamsonSpecialty: Clinical trial operations, immunotherapy development, rare and high-risk oncology indications Episode OverviewLive 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 Moments00:02:05 – 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 TakeawaysPrioritize 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 & ResourcesThe PBC Group – COG Event Series: Agendas, blog, and further clinical operations contentFaron PharmaceuticalsPeer-Reviewed Analysis (Faron with Yale): 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: hhttps://thepbcgroup.com ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group

    21 min
  5. The Future of Risk Based Quality Management for Early Phase Studies with Duncan Hall

    Mar 31

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

    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 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 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. 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. 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 – Event agendas, blog, and resources from Clinical Outsourcing Group meetings ICH E6(R3) Guidance – Latest regulatory guidance on GCP and RBQM TRI – 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: hhttps://thepbcgroup.com ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group

    22 min

  6. Feb 26

    Leveraging Key Opinion Leaders in Clinical Research Strategy and Execution With Thierry Schulmann

    Discover how early engagement with key opinion leaders transforms clinical trial outsourcing decisions, reduces program risk, and optimizes clinical operations for higher-impact trial outcomes. GuestThierry Schulmann, Senior Director, Medical Affairs Strategy, Sumitomo Pharma (LinkedIn) Episode OverviewThis episode—recorded live at COG Europe—features Thierry Schulmann, Senior Director, Medical Affairs Strategy at Sumitomo Pharma, in a highly practical session focused on the operational value of engaging key opinion leaders (KOLs) early in clinical research. Listeners will gain a clear framework for involving KOLs at each stage of clinical trial outsourcing, from initial design and feasibility to trial execution and market access. Drawing from real-world case studies, Thierry Schulmann illustrates how underestimating KOL input can lead to misalignment on endpoints, failed market launches, or unmet regulatory expectations—even in otherwise well-executed trials. The discussion covers: Why CRO selection should account for KOL expertise and therapeutic alignmentHow to use KOL engagement to build patient-centered protocols and enhance feasibility, recruitment, and retentionThe impact of KOLs on regulatory strategy, payer acceptance, guideline inclusion, and real-world implementation For clinical operations professionals, outsourcing leads, and vendor managers, the episode provides actionable strategies to protect trial value, avoid program pitfalls, and ensure the commercial relevance of new therapies through smarter stakeholder engagement and clinical study optimization. Key Moments00:02:10 – Framing the risks: Why approved products still fail to launch due to misaligned trial endpoints and weak stakeholder input 00:03:13 – Case study: The commercial impact of not localizing active comparators for European market expectations 00:04:58 – Why strategic KOL engagement is a form of "outsourcing" critical expertise beyond CRO selection 00:07:13 – Clinical operations best practice: Focusing on endpoints that drive real-world adoption, not just statistical significance 00:09:28 – Bridging gaps: KOLs as operational connectors between academic protocols, regulatory requirements, and patient needs 00:10:40 – Regulatory navigation: How global KOL networks inform region-specific trial design and submission strategies 00:13:19 – Leveraging KOL and patient group relationships for evidence generation in rare and serious diseases 00:14:47 – Ensuring real-world effectiveness: The role of KOLs in validating trial design beyond controlled settings 00:18:30 – Lessons learned: When missed KOL input on comparator choice, unmet need assessment, or side effect profiles led to program failures 00:21:36 – When to engage KOLs: Practical recommendations for biotech and pharma, starting as early as Phase 1 Top 3 TakeawaysProactive KOL engagement in early trial design is essential for successful clinical trial outsourcing and market access—don't wait until later phases to bring real-world and regulatory perspectives into protocol development.Aligning clinical study endpoints and comparators with both therapeutic practice and payer requirements optimizes trial relevance and supports smoother regulatory acceptance—a key consideration in clinical operations best practices and CRO selection.Building cross-functional collaboration with KOLs bridges gaps among sponsors, CROs, patient groups, and regulatory bodies, minimizing risk of costly rework and maximizing the practical value of clinical study optimization. Quotes"Making a study without launching it in the markets doesn’t make sense. Involve key opinion leaders early to ensure you’re not just building a study for science, but for real patient impact." — Thierry Schulmann "Endpoints matter, but they must be clinically relevant. KOLs help ensure that what is statistically significant is also meaningful for adoption and payer acceptance." — Thierry Schulmann "KOLs are not just scientific advisors—they bridge patient, regulatory, and market realities with sponsor strategy, reducing the risk of misaligned or commercially unviable trials." — Thierry Schulmann "The reason products don’t launch isn’t always technical failure—it’s often weak alignment to the actual unmet need, pricing pressure, or irrelevance to local practice. KOL insight is the antidote." — Thierry Schulmann "If you have a product, even in Phase 1, you should start discussing with KOLs. Don’t wait—disease awareness and unmet need education set the foundation for successful trial and market outcomes." — Thierry Schulmann ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group

    23 min

  7. Feb 19

    Navigating Biotech’s First-in-Human Trial in Rare Disease With Jurate Lasiene

    Learn how small biotech’s can streamline clinical trial outsourcing, optimize CRO selection, and establish truly patient-centered operations for rare disease studies—while maintaining high data quality and speed. GuestJurate Lasiene, VP Clinical Operations, North Sea TherapeuticsLinkedIn: Jurate Lasiene Episode OverviewThis episode of The COG Review: Building Better Clinical Studies is recorded live at COG Europe in Amsterdam. Jurate Lasiene, VP Clinical Operations at North Sea Therapeutics, shares firsthand insights from managing a first-in-human, early-phase rare disease trial with a small, agile biotech team. The session explores critical decision points and real-world solutions in clinical trial outsourcing, CRO selection, and effective sponsor–vendor collaboration. Key topics include designing adaptive, patient-first protocols for challenging rare disease populations, the shift from traditional full outsourcing models to targeted FSP (Functional Service Provider) or hybrid approaches, and optimizing budget, speed, and quality by retaining operational control in-house where it matters most. Jurate Lasiene offers a practical breakdown of site and partner selection, early regulatory and KOL engagement, and hands-on clinical operations best practices. This episode equips clinical research professionals in biotech, pharma, and CROs with actionable frameworks for clinical study optimization—especially useful for those navigating complex trials with lean teams and limited resources. Listeners gain concrete guidance on the sponsor-side leadership choices and process refinements that reduce common failure points and accelerate study timelines. Key Moments00:01:40 – The unique operational challenges of rare disease trials: small, dispersed patient populations and high rates of trial discontinuation 00:03:41 – Why small biotech’s are driving the majority of clinical trial starts and how their outsourcing strategies have evolved 00:04:31 – Clinical trial protocol design: avoiding rigid endpoints and restrictive eligibility to improve enrollment and retention 00:05:16 – The necessity of integrating patient and caregiver input early for truly patient-centered clinical trials 00:06:45 – How to select clinical trial sites: speed, fit, and operational capacity versus academic prestige 00:08:31 – Practical cost-savings from targeted FSP models: 30% budget reduction by outsourcing only specialty capabilities 00:10:23 – Engaging KOLs and patient advocacy groups at the protocol development stage for better outcomes 00:11:41 – Keeping oversight in-house with dedicated monitors/PMs: advantages for quality and site engagement 00:13:27 – Building a “meshwork” of specialist partners to keep small teams agile, responsive, and in control 00:16:46 – Simulating the patient journey to optimize protocol, logistics, and site operations for clinical study optimization Top 3 TakeawaysEarly and deep integration of clinical operations into trial and protocol design is essential for avoiding downstream roadblocks—making this a core clinical operations best practice.Targeted outsourcing and deliberate CRO selection (favoring fit and flexibility over scale alone) enables small teams to maintain control, ensure sponsor oversight, and optimize budgets.Mapping the exact patient (and caregiver) journey—through direct simulation and advocacy group input—prevents oversights, reduces participant burden, and improves enrollment and retention in rare disease studies. Links & ResourcesRare Disease Clinical Trials Toolkit – Clinical Trials Transformation Initiative (CTTI)Clinical Operations Best Practice Resources—PBC Group Blog Quotes“Protocol and study design cannot be rigid—it’s critical your endpoints are meaningful and achievable for rare disease populations.” – Jurate Lasiene “We developed a strong sponsor-site-vendor collaboration... Different partners were extensions of our in-house team exactly where and when needed.” – Jurate Lasiene “Walking the patient journey ourselves—wheelchairs, waiting rooms, paperwork—changed how we approached the protocol entirely. You don’t know the burden unless you see it firsthand.” – Jurate Lasiene “Small biotech’s can run early-phase rare disease trials successfully if they combine patient-first design, deep clinical operations knowledge, and targeted FSP outsourcing.” – Jurate Lasiene “It’s important to choose partners that work for you, with you—not just imposing their way of doing things.” – Jurate Lasiene ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group

    26 min
  8. From Outsourcing to Orchestrating: The Clinical Mesh Playbook with Maria Expósito Lorido

    Feb 12

    From Outsourcing to Orchestrating: The Clinical Mesh Playbook with Maria Expósito Lorido

    Discover operational strategies to move beyond traditional clinical trial outsourcing—learn how the clinical mesh approach can optimize study speed, oversight, and cost efficiency for today’s clinical operations leaders. GuestMaria Expósito Lorido (LinkedIn)Venture Partner, Vu Venture PartnersExtensive experience in clinical development, clinical trial outsourcing, and operational leadership within pharma/biotech Episode OverviewThis live session from COG Europe in Amsterdam features Maria Expósito Lorido, a leading venture partner with hands-on experience designing and implementing innovative clinical outsourcing strategies. Maria offers a compelling presentation shifting the conversation from conventional CRO selection and outsourcing models to a new paradigm: sponsor-led orchestration through the clinical mesh playbook. Listeners gain practical guidance on clinical operations best practices by contrasting traditional outsourcing with platform and ecosystem-based models. Maria reveals why most studies fall short on recruitment, what it costs, and how an orchestrated mesh of specialized partners can reduce delays and increase value for sponsors and patients alike. Specific areas covered include how to tailor sourcing architecture to your study’s needs, which operational components to retain or externalize, and ways to apply clinical study optimization principles for faster, more flexible trial delivery. The episode also addresses implementation steps, measurable KPIs, and critical sponsor responsibilities in this emerging model. Ideal for clinical operations, outsourcing managers, and vendor strategy professionals seeking to future-proof their approach to CRO selection and clinical trial outsourcing. Key Moments00:03:00 – Why 80% of clinical studies miss recruitment targets and the financial impact of delays 00:05:00 – Comparing small, agile biotech teams vs large pharma R&D models for clinical trial delivery 00:06:55 – The Nvidia platform analogy: platform business models vs linear development pipelines 00:07:10 – Introduction to the “clinical mesh” model: moving from fixed structures to reconfigurable networks 00:08:33 – Three sourcing architecture types—full-service CRO, functional service provider, and clinical mesh—and when each works best 00:11:23 – Governance challenges and sponsor responsibilities under the mesh model 00:14:04 – Early-stage oncology case study: cost, timelines, and screen failure rate compared across outsourcing models 00:16:27 – Quality management, risk, and safety oversight: what sponsors must own when orchestrating a clinical mesh 00:18:57 – KPIs for clinical study optimization: measuring cost per qualified patient, time to first contact, and more 00:19:43 – 90-day roadmap for piloting a clinical mesh approach with stepwise best practices Top 3 TakeawaysOrchestrate, don’t just outsource: Sponsors retain strategy, quality, and data oversight even when leveraging a network of specialized vendors—this increases flexibility and operational control compared to traditional outsourcing.Match sourcing architecture to study needs: Evaluate each study to determine the best-fitting sourcing model (full-service CRO, hybrid/FSP, or clinical mesh), rather than defaulting to a single approach for all trials.Pilot and measure for impact: Implement outcome-based KPIs (e.g., cost per qualified patient, time to last patient in) and compare mesh-driven pilots to traditional models for real-world evidence of clinical operations best practices. Links & ResourcesThe PBC Group — COG Review Podcast & EventsLinkedIn: Maria Expósito Lorido Quotes“Instead of asking which CRO to use, we should define the right sourcing architecture based on the study’s maturity and needs.” — Maria Expósito Lorido “This is a wake-up call. The value lies in building platforms and ecosystems, not just pipelines.” — Maria Expósito Lorido “In the mesh model, sponsors own quality management, integrated risk plans, and data integrity—it’s orchestration, not abdication.” — Maria Expósito Lorido “You don’t need a revolution, just a well-designed first pilot. Start small; scale what works.” — Maria Expósito Lorido “The future belongs to platform thinking. The winners will be those who can compose the right ecosystem for each study.” — Maria Expósito Lorido ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 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.

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