Explore every episode of the podcast The COG Review: Building Better Clinical Studies
| Title | Pub. Date | Duration | |
|---|---|---|---|
| Introducing The COG Review: Building Better Clinical Studies | 08 Dec 2025 | 00:01:18 | |
Better trials. Fewer delays. Improved outcomes. The COG Review: Building Better Clinical Studies brings you the strongest sessions from the COG meeting series, recorded on site and selected for what helps teams move now. Senior leaders, study owners, and problem solvers share what works so effective treatments reach patients sooner. What you will hear across the season:
If you work in clinical operations or outsourcing, and you own delivery targets, this is built for you. Episodes run around 25 minutes and focus on insights you can use right away. Follow The COG Review: Building Better Clinical Studies in your podcast app. Learn more by heading to thepbcgroup.com. | |||
| Leveraging Key Opinion Leaders in Clinical Research Strategy and Execution With Thierry Schulmann | 26 Feb 2026 | 00:23:09 | |
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. Guest
Episode Overview This 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:
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 Takeaways
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 | |||
| Navigating Biotech’s First-in-Human Trial in Rare Disease With Jurate Lasiene | 19 Feb 2026 | 00:26:26 | |
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. Guest
Episode Overview This 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 Takeaways
Links & Resources
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 | |||
| From Outsourcing to Orchestrating: The Clinical Mesh Playbook with Maria Expósito Lorido | 12 Feb 2026 | 00:27:33 | |
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. Guest
Episode Overview This 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 Takeaways
Links & Resources 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 | |||
| Global Shift: Outsourcing Clinical Trials In A Changing World with Heike Schoen | 29 Jan 2026 | 00:28:01 | |
Navigating Global Clinical Trial Outsourcing: Risk, Strategy & CRO Partnerships in a Changing World Gain operational clarity on the evolving landscape of clinical trial outsourcing—discover the risk factors, partnership models, and geographic strategies reshaping CRO selection and clinical operations. Guest
Recorded live at COG Europe, Amsterdam. Episode OverviewThis episode of The COG Review: Building Better Clinical Studies features Heike Schoen, CEO of Loomis International, in a keynote session from COG Europe. The discussion centers on the global shift in clinical trial outsourcing, with a sharp focus on how sponsors and CROs are adapting to rapid changes in regulation, geopolitics, and technological innovation. Heike Schoen explores the evolution of sponsor–CRO partnerships, from transactional service agreements to nuanced hybrid models, where flexibility and deep therapeutic expertise are essential for success. Practical examples from Novartis–PPD and Moderna–Medidata illustrate both functional service partnerships and the impact of digital, decentralized trials. Key areas include CRO selection strategies for emerging markets, navigating regulatory changes, and building operational agility in the face of supply chain fragility and geopolitical risk. Insights are tailored for professionals involved in clinical operations best practices, outsourcing decisions, and those seeking to optimize clinical studies through smarter partnerships and technology use. The session closes with real-world challenges and live audience questions on how to structure outsourcing models, respond to regulatory shifts, and future-proof location choices for clinical trials. Key Moments00:03:37 – Global clinical trial outsourcing market growth and drivers 00:04:45 – The rise of hybrid CRO partnerships: strategic alliances vs. modular models 00:06:06 – Digital platforms and AI: boosting operational efficiency in decentralized trials 00:07:00 – CROs must demonstrate deep therapeutic expertise and flexible service models 00:08:15 – Geographic diversification: assessing emerging markets for clinical study optimization 00:10:06 – AI’s impact on CRO value pools: standardization and resource allocation 00:12:09 – Comparative advantages of clinical outsourcing in the US, Asia-Pacific, Europe, Latin America, Africa, and the Middle East 00:14:24 – Geopolitical risks in outsourcing: contingency planning for disruption and instability 00:16:08 – Supply chain fragility and cross-border data management: lessons for clinical operations best practices 00:18:10 – Key drivers for outsourcing strategy: cost pressure, patient diversity, regulatory speed 00:19:49 – Location strategy essentials and what sponsors should expect from CROs 00:24:29 – Guidance for small biotechs on engaging CROs and designing flexible outsourcing models Top 3 Takeaways
Links & Resources
Quotes “CROs are no longer simply generalists—they’re expected to offer deep therapeutic specialization and the agility to scale services as sponsors’ needs change.” — Heike Schoen “Location strategy matters more than ever before. Regulatory and political stability are now core criteria in both site and CRO selection.” — Heike Schoen “The shift to hybrid outsourcing models allows sponsors to retain expertise in-house while leveraging CRO resources for specialized functions, giving teams more flexibility to manage complex trials.” — Heike Schoen “The impact of AI on CROs will disrupt up to 30% of traditional value pools, from monitoring to medical writing, driving efficiency but requiring teams to rethink resource allocation.” — Heike Schoen “Contingency planning for geographic disruption isn’t optional anymore—it’s essential for every sponsor managing clinical trial outsourcing in a volatile world.” — Heike Schoen ----------- Further content and agendas: hhttps://thepbcgroup.com | |||
| Leadership Insights into Pipeline Strategy with Emily Roberts-Thomson, Raj Patel, Nikhil Dube, and Mukhtar Ahmed | 22 Jan 2026 | 00:26:02 | |
Pipeline Strategy: Balancing Science, Feasibility, and ROI in Clinical Development Decisions What does it take to make confident, cross-functional pipeline decisions that drive approval speed and sustainable value for companies in today’s clinical research landscape? Moderated by Emily Roberts-Thomson, Development Operations Leader Featuring: • Raj Patel, Chief Operating Officer, ReacX Pharmaceuticals • Nikhil Dube, Lifecycle Management Strategy Lead, Biogen • Mukhtar Ahmed, Director, Project and Portfolio Strategy, Greenstone Biosciences Recorded live at COG Bay Area, this panel brings together senior voices from leading biotech and pharma organizations to tackle the realities of pipeline prioritization and clinical operations best practices. Moderated by Emily Roberts-Thomson, the discussion centers on actionable frameworks and leadership judgment required for effective clinical trial outsourcing, CRO selection, and cross-functional portfolio management. The panelists break down how organizations decide which programs to advance, weighing scientific potential against development feasibility, market factors, risk, and resource constraints. They candidly explore trade-offs inherent to outsourcing strategies, clinical study optimization, and how changes in ROI, timelines, or operational setbacks impact pipeline decisions. Essential listening for clinical operations leaders, outsourcing specialists, and study owners, the episode delivers practical insights on moving from scientific conviction to commercial success—and ensuring alignment across sponsors, CRO partners, and governance bodies in a rapidly shifting environment for clinical trial outsourcing. Key topics include:
Key Moments 00:03:20 – Emily Roberts-Thomson frames the multifactor decision: “It’s never just about how good the science is. It’s about feasibility, market dynamics, and resource allocation.” 00:04:00 – Raj Patel outlines a practical pipeline selection matrix: fastest to approval, least cost, minimal risk—plus the real-world influence of boardroom priorities and investor interests. 00:05:00 – Nikhil Dube shares a three-pronged approach: scientific value, clinical development feasibility, and commercial opportunity—all critical for clinical study optimization and vendor selection frameworks. 00:06:37 – Mukhtar Ahmed describes a hybrid model leveraging academic depth and operational agility, focusing on robust human data and milestone-driven inflection points for outsourcing viability. 00:08:02 – Panel debate: How companies trade off first-in-class scientific programs against downstream commercial opportunity when making outsourcing or CRO selection decisions. 00:13:28 – Emily Roberts-Thomson and Raj Patel candidly discuss the reality of reprioritizing clinical studies based on changing business needs and operational feasibility—impacting CRO and vendor engagement. 00:14:29 – Achieving cross-functional consensus: Lessons from balancing scientific advocacy, operational feasibility, and business priorities in pipeline governance. 00:17:05 – Raj Patel on how investors and shifting market landscapes dictate which programs move forward—and how funding realities drive clinical outsourcing strategies. 00:19:13 – Nikhil Dube unpacks how project leads in large pharma orchestrate collaboration across research, development, commercial, and outsourcing teams for better governance and vendor alignment. 00:22:56 – Mukhtar Ahmed on the importance of transparent, all-hands communication and real-world feasibility checks with KOLs and clinical trial site experts when planning outsourcing for early-phase studies. Top 3 Takeaways
Links & Resources Clinical Outsourcing Group (COG) Events – https://thepbcgroup.com/cog-events Biogen – https://www.biogen.com Greenstone Biosciences – https://greenstonebio.com ReacX Pharmaceuticals – https://reacxpharma.com/ National Institute on Drug Abuse – https://nida.nih.gov Quotes“It’s never just about how good the science is. It’s about balancing the potential with feasibility, market dynamics, and resource allocation.” – Emily Roberts-Thomson “You have to make some tough decisions… which product will give you the fastest approval, for the least money, with minimal risk.” – Raj Patel “Every company uses the same three pillars: scientific conviction, development feasibility, and commercial opportunity.” – Nikhil Dube “If you don’t have the funds, you might have the best science, but you’re not going to get anywhere.” – Raj Patel “We try to always come back to how quickly we can get human-relevant data, early on. That’s what drives both scientific confidence and investor capital.” – Mukhtar Ahmed “Cross-functional alignment is near and dear… silos have no place in small biotech.” – Mukhtar Ahmed ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group | |||
| AI Integration: Outsourcing Now and Next with Paulius Ojeras | 14 Jan 2026 | 00:32:19 | |
AI Integration in Clinical Trial Outsourcing: Best Practices for Operational Efficiency and CRO Selection Learn how AI agents are reshaping clinical study optimization, enhancing quality and scalability in clinical trial outsourcing—and what you need to know for smarter CRO selection and oversight. Featuring:
This live session, recorded at COG Bay Area, features Paulius Ojeras, Head of Clinical Operations at Perceive Biotherapeutics, as he shares hands-on insights about integrating AI agents into clinical operations and outsourcing models. The discussion is grounded in practical experience, with real examples from Perceive’s studies. The core theme revolves around how clinical trial outsourcing strategies evolve—and sometimes fundamentally change—when sponsors adopt AI-driven solutions for process automation, team scalability, and quality management. Paulius Ojeras breaks down where AI makes the biggest difference, from TMF (Trial Master File) management to site startup and document QC, offering lessons learned for sponsor teams evaluating new outsourcing approaches. Key topics include frameworks for CRO selection, managing vendor relationships in an AI-enabled environment, and de-risking operational transitions. The episode emphasizes clinical operations best practices—particularly how to balance technology adoption with oversight, accountability, and regulatory requirements—giving actionable guidance for teams focused on clinical study optimization and sponsor–CRO partnership models. Key Moments00:02:43 – Why the real question isn’t if AI will disrupt clinical trials, but how smart and fast sponsors will adopt AI solutions 00:05:00 – Breakdown of AI integration levels: from basic automation to autonomous, agentic AI teammates in clinical operations 00:09:47 – Case study: Applying AI agents to TMF management—quality gains and lessons from real deployment at Perceive Biotherapeutics 00:13:43 – AI-driven QC finds up to 25% errors in TMF documentation, challenging norms in clinical trial outsourcing 00:15:13 – Real-time document feedback and task tracking—how automation improves speed and regulatory compliance 00:18:11 – Vendor selection due diligence: key criteria for assessing AI-focused clinical trial outsourcing partners 00:21:31 – Addressing the challenge of outcome consistency: why it’s critical for regulated clinical trials and CRO selection 00:24:38 – Rethinking process design for end-to-end automation, not just adding tools to legacy workflows 00:25:37 – The importance of training internal teams for AI literacy and prompt engineering to maximize value from technology 00:26:31 – Final guardrail: Success depends on thoughtful, disciplined AI adoption—not just speed or hype Top 3 Takeaways
Links & Resources The PBC Group: https://thepbcgroup.com Perceive Biotherapeutics: https://perceivebio.com Quotes“Clinical operations remain very human-intensive—yet with agentic AI, we can rethink how we execute trials, building scalability and quality into every step.” — Paulius Ojeras “When assessing emerging vendors, look for live deployments, reference use cases, and financial runway. Don’t buy the hype—buy the solution your team actually needs.” — Paulius Ojeras “In highly regulated environments, consistency is the hardest challenge for AI. Ask your vendor how they independently verify the outcome of their agents.” — Paulius Ojeras “Human intelligence is essential to set up and oversee AI teammates—everything else should be designed for autonomous, high-quality delivery.” — Paulius Ojeras ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group | |||
| Meaningful Patient Engagement in Clinical Trials: Beyond Tokenism to True Value with Lisa Lea | 09 Jan 2026 | 00:20:36 | |
Embedding the Patient Voice: Best Practices for Patient Engagement in Clinical Trial Outsourcing Discover how integrating meaningful patient engagement strategies throughout clinical trial outsourcing can drive study optimization, reduce recruitment delays, and create more inclusive, effective clinical research. Guest
Episode Overview This episode, recorded live at COG Bay Area, features Lisa Lea, Director of Patient Insights at Merck, sharing actionable frameworks for incorporating real patient perspectives into every stage of clinical trial outsourcing and operations. In a session tailored to trial sponsors, CROs, and operational leaders, Lisa Lea draws on two decades of industry and clinical site experience to address the operational and strategic value of authentic patient engagement. You'll gain a grounded perspective on how early, frequent patient input enhances CRO selection and clinical study optimization. From adjusting inclusion criteria and endpoint selection to reducing recruitment challenges and addressing protocol burdens, learn how patient-centered approaches create efficiencies and improve outcomes across the outsourced trial lifecycle. Key topics include:
Key Moments 00:02:45 – Defining “patient engagement” and why it matters for clinical trial operations 00:03:59 – The real-world operational risks of omitting patient voice: recruitment shortfalls and study delays 00:06:55 – Historical drivers: How patient advocacy reshaped regulatory expectations and clinical outsourcing approaches 00:08:08 – Balancing patient risk–benefit preferences in protocol and CRO/vendor collaboration 00:09:07 – Impact of patient engagement on diverse recruitment, site selection, and CRO performance 00:10:42 – Actionable steps: Where and how to embed patient insights in the clinical development and outsourcing pathway 00:13:03 – Real example: Protocol design oversights leading to lost sites, and learnings for sponsor–CRO study teams 00:14:40 – Participants’ desire for real influence, not token feedback—building feedback loops for operational improvement 00:16:09 – Key regulatory guidances and industry resources for patient-centric trial design and clinical outsourcing decisions 00:17:15 – Overcoming practical barriers: Internal advocacy, framework creation, and pilot programs for patient engagement Top 3 Takeaways
Links & Resources:
Quotes: “Clinical trials are ultimately about people. If the design, conduct, and measurement don’t resonate with patients, participation and retention—as well as the relevance of the trial—really pay a price.” – Lisa Lea “Engaging with patients early and often is really going to help the process and improve your clinical trials. It’s not just a nice-to-have—it’s more and more a need-to-have.” – Lisa Lea “There’s about 80% of clinical trials that fail to meet their recruitment goals. A lot of that can be attributed to patient burden—something we can address through stronger engagement.” – Lisa Lea “Patients do not want to feel like they’re checking a box. They want to feel like their input is valued. So providing some sort of feedback loop is key.” – Lisa Lea “To do clinical outsourcing well, incorporating the patient voice is crucial—not just possible.” – Lisa Lea ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group | |||
| Optimizing Stakeholder Engagement for Timely Completion of Clinical Trials with Kimberly Guedes | 16 Dec 2025 | 00:31:51 | |
Optimising Stakeholder Engagement: Clinical Trial Outsourcing, CRO Selection, and Delivery Best Practices with Kimberly Guedes Discover actionable strategies to align incentives, clarify roles, and streamline communication for faster, more predictable clinical trial delivery—essential listening for anyone involved in clinical trial outsourcing, CRO selection, or operational leadership. Guest
Episode Overview Recorded live at a Clinical Outsourcing Group (COG) Bay Area event and introduced by David Jones, this episode features Kimberly Guedes, VP Clinical Operations at Intensity Therapeutics. In her keynote, Kimberly addresses the operational realities and leadership challenges of optimising stakeholder engagement in clinical trial delivery. The session offers practical insight into the core factors behind study delays, the importance of early alignment, and communication strategies that underpin successful clinical trial outsourcing programmes. Clinical operations professionals, outsourcing leads, and vendor managers will find a grounded framework for ensuring clarity between sponsors, CROs, service vendors, and research sites. Topics include:
This episode is designed for those seeking proven clinical operations best practices to help accelerate timelines, improve outsourcing partnerships, and enhance delivery outcomes. Key Moments00:03:20 – Defining stakeholder engagement in the context of clinical trial outsourcing and delivery 00:04:11 – Understanding unique perspectives and constraints of sponsors, CROs, vendors, sites, and patients 00:05:09 – Building predictability and trust through early, honest communication 00:06:54 – Risks of poor engagement: delays, rework, low morale, and project failure 00:08:02 – The importance of joint project planning and cross-functional team training 00:10:03 – Creating a culture of mutual respect, transparency, and recognition with partners 00:12:03 – Establishing clear roles, responsibilities, and governance for effective CRO/vendor partnerships 00:14:56 – The impact of understanding team members' strengths, backgrounds, and communication styles 00:18:16 – Shifting from reactive blame to collaborative problem solving in clinical operations 00:19:26 – Empowering all stakeholders to ask questions and contribute new ideas for study optimisation 00:27:15 – Best practices for engaging remote or distributed teams in clinical outsourcing delivery Top 3 Takeaways
Links & Resources Quotes “We’re all a team and we all have something to gain here and we have a lot to lose here—we build more rapport and trust if we can have honest conversations, even if they’re not always easy.” – Kimberly Guedes “If you don’t know the constraints of your partners, or the timelines they can realistically deliver, then you’ve failed already—those conversations need to happen before your protocol is even finalised.” – Kimberly Guedes “It’s not about blame; it’s about how we pick up the ball and work together to get to the end zone—focus on solutions rather than pitfalls.” – Kimberly Guedes “Being clear in your communications—what needs to be done, by whom, and when—creates predictability and reduces costly rework. Ambiguity is the enemy of timely delivery.” – Kimberly Guedes “Everyone wants to feel like they are part of something. Empowering sites, participants, CROs, and sponsors—all stakeholders—not only improves retention, it’s the mark of successful clinical outsourcing.” – Kimberly Guedes ----------- Further content and agendas: hhttps://thepbcgroup.com Copyright 2026 The PBC Group | |||
| Strategic CRO Selection & Vendor Partnerships: Real-World Approaches for Emerging Biopharma | 12 May 2026 | 00:38:29 | |
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
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:
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 Takeaways
Links & Resources
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 | |||
| The State of Clinical Trial Outsourcing in the UK: Optimizing Site Selection, Resources, and Performance | 28 Apr 2026 | 00:43:26 | |
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
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
Top 3 Takeaways
Links & Resources
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 | |||
| Designing Clinical Trials to Avoid Historical Failures in HR-MDS with Joab Wiliamson | 14 Apr 2026 | 00:20:44 | |
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
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 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 Takeaways
Links & Resources
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 | |||
| The Future of Risk Based Quality Management for Early Phase Studies with Duncan Hall | 31 Mar 2026 | 00:22:09 | |
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
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 Moments00:02:27 – 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
Links & Resources
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 | |||