Speaker

• Joab Williamson
• VP of Operations, Faron Pharmaceuticals
• LinkedIn: Joab Williamson
• 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: Agendas, blog, and further clinical operations content
• Faron Pharmaceuticals
• Peer-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

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Further content and agendas: hhttps://thepbcgroup.com

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Further content and agendas: hhttps://thepbcgroup.com

Copyright 2026 The PBC Group

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

1. Patient-level Data Review: For early phase studies, adopting a patient-centric review model—rather than site-to-site comparison—enhances safety oversight and aligns with RBQM principles, marking a clinical operations best practice.
2. Validated Technology vs. Manual Tools: Relying on spreadsheets and email for clinical study optimization risks non-compliance and inefficiency; purpose-built, validated systems improve both operational outputs and regulatory readiness.
3. Adapt Technology and Pricing: Technology vendors should offer flexible pricing and purpose-designed platforms to enable smaller sponsors and biotechs to implement RBQM without prohibitive costs, supporting better CRO selection and clinical trial outsourcing outcomes.

Links & Resources

• The PBC Group – 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

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Further content and agendas: hhttps://thepbcgroup.com

Copyright 2026 The PBC Group

Guest

1. Thierry Schulmann, Senior Director, Medical Affairs Strategy, Sumitomo Pharma (LinkedIn)

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:

1. Why CRO selection should account for KOL expertise and therapeutic alignment
2. How to use KOL engagement to build patient-centered protocols and enhance feasibility, recruitment, and retention
3. The 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 Moments

00:02:10 – 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

1. Proactive 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.
2. 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.
3. 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

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Further content and agendas: hhttps://thepbcgroup.com

Copyright 2026 The PBC Group

Guest

1. Jurate Lasiene, VP Clinical Operations, North Sea Therapeutics
2. LinkedIn: Jurate Lasiene

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 Moments

00:01:40 – 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

1. Early 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.
2. 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.
3. 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 & Resources

1. Rare Disease Clinical Trials Toolkit – Clinical Trials Transformation Initiative (CTTI)
2. 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

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Further content and agendas: hhttps://thepbcgroup.com

Copyright 2026 The PBC Group

Guest

1. Maria Expósito Lorido (LinkedIn)
2. Venture Partner, Vu Venture Partners
3. Extensive experience in clinical development, clinical trial outsourcing, and operational leadership within pharma/biotech

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 Moments

00:03:00 – 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

1. Orchestrate, 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.
2. 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.
3. 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 & Resources

1. The PBC Group — COG Review Podcast & Events
2. LinkedIn: 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

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Further content and agendas: hhttps://thepbcgroup.com

Copyright 2026 The PBC Group

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

1. Heike Schoen, CEO, Loomis International (LinkedIn)
2. 20+ years in clinical operations, global trial strategy, and vendor management
3. Bart Scheerder, Host
4. Authority in European clinical operations and outsourcing trends
5. David Jones, Head of Content, The PBC Group

Recorded live at COG Europe, Amsterdam.

Episode Overview

This 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 Moments

00:03:37 – 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

1. Hybrid CRO partnership models are becoming standard—sponsors should seek partners who can offer both full-service and functional capabilities to improve flexibility and execution speed.
2. Geopolitical risk mitigation and supply chain planning are now core to clinical trial outsourcing decisions; build contingency plans and select CROs with multi-jurisdictional expertise.
3. Digital technology and real-time data analytics are advancing clinical study optimization; prioritize CRO selection processes that assess digital readiness and regulatory adaptability.

Links & Resources

1. The PBC Group – Events & Blog
2. Boston Consulting Group: AI in CRO Value Pools
3. Medidata Decentralized Trials Resource

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

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Further content and agendas: hhttps://thepbcgroup.com

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:

1. Balancing science, feasibility, and business drivers in pipeline advancement decisions
2. Managing cross-functional alignment across R&D, clinical operations, and commercial teams for better governance
3. The critical role of financing, investor expectations, and real-world feasibility in CRO selection and vendor management

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

1. Balance Science and Feasibility with Business Realities
2. Even the most promising science requires practical validation against operational costs, study feasibility, and commercialization potential—crucial for smart clinical trial outsourcing and CRO selection.
3. Cross-Functional Collaboration Drives Success
4. Early, transparent input from R&D, clinical operations, and commercial leaders creates alignment and sets up clinical operations best practices for study optimization and outsourcing partnerships.
5. Investor and Market Pressures Shape Pipeline and Outsourcing Choices
6. Shifts in funding, risk tolerance, and evolving market needs can upend study priorities—requiring agile, milestone-based approaches and robust clinical outsourcing governance.

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

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Further content and agendas: hhttps://thepbcgroup.com

Copyright 2026 The PBC Group

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:

1. Paulius Ojeras, Head of Clinical Operations, Perceive Biotherapeutics (LinkedIn),
2. 18+ years’ experience in biotech and global CRO management; specialist in innovative trial designs, outsourcing strategy, and the operational application of emerging technologies.

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 Moments

00:02:43 – 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

1. Prioritize solutions over tools: When evaluating clinical trial outsourcing options, select vendors who offer true operational support (setup, oversight, supervision), not just technology. This is key for effective CRO selection and minimizing added complexity.
2. Redesign processes for automation: For clinical operations best practices, rethink workflows to fully leverage AI agents—instead of layering automation on top of manual processes—to drive scalability and quality in study delivery.
3. Validate consistency and accountability: In any clinical study optimization strategy, ensure AI-enabled solutions meet regulatory demands for outcome consistency and clear accountability. Always demand testing, independent benchmarks, and a robust oversight framework from vendors.

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

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Further content and agendas: hhttps://thepbcgroup.com

Copyright 2026 The PBC Group

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

1. Lisa Lea
2. Director of Patient Insights, Merck
3. Over 20 years of biotech and clinical expertise
4. Specialist in pulmonary arterial hypertension and patient-centered trial design
5. LinkedIn

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:

1. The regulatory evolution of patient engagement, with lessons for clinical outsourcing models
2. Operational benefits, such as fewer delays and more relevant data through improved trial design
3. Practical methods for embedding patient voice in trial protocols and vendor collaboration
4. 
   
5. This session offers both strategic guidance and frontline examples you can apply to clinical operations best practices, CRO selection, and effective sponsor–CRO–patient partnerships.

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

1. Early and frequent patient input—starting before CRO selection—can preempt recruitment failures and reduce costly protocol amendments, directly supporting clinical study optimization.
2. Establishing structured patient engagement frameworks and closing the feedback loop with trial participants strengthens sponsor–CRO collaboration and drives operational excellence.
3. Prioritizing patient-relevant endpoints and burden reduction creates more diverse, successful trials—delivering greater value to sponsors, CROs, and, most importantly, patients.

Links & Resources:

1. The PBC Group: https://thepbcgroup.com
2. EUPATI (European Patients’ Academy): https://www.eupati.eu
3. FDA Patient-Focused Drug Development Guidance: https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical
4. DIA Patient Engagement e-Learning: https://www.diaglobal.org/en/course-listing#

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

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Further content and agendas: hhttps://thepbcgroup.com

Copyright 2026 The PBC Group

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

1. Kimberly Guedes
2. Vice President, Clinical Operations, Intensity Therapeutics
3. 30+ years’ experience in global drug development across preclinical to Phase IV studies
4. Leader in process improvement, vendor management, and clinical operations strategy
5. LinkedIn

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:

1. The dynamics of stakeholder collaboration in clinical outsourcing models
2. Criteria for effective CRO selection and ongoing governance
3. Methods for bridging communication gaps and achieving clinical study optimisation
4. Handling team changes, fostering trust, and responding to practical constraints

This episode is designed for those seeking proven clinical operations best practices to help accelerate timelines, improve outsourcing partnerships, and enhance delivery outcomes.

Key Moments

00:03:20 – 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

1. Initiate open, honest conversations about constraints and expectations early in the outsourcing process to set realistic study timelines and avoid costly delays (CRO selection and clinical trial outsourcing).
2. Establish—and regularly review—clear roles, responsibilities, and escalation pathways with all stakeholders to drive accountability and ensure effective governance (clinical operations best practices).
3. Foster ongoing, two-way communication and inclusivity across sponsor, CRO, and site teams, recognising the value of both formal meetings and informal, human connection to enhance engagement and project continuity (clinical study optimisation).

Links & Resources

Intensity Therapeutics

Kimberly Guedes on LinkedIn

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

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Further content and agendas: hhttps://thepbcgroup.com

Copyright 2026 The PBC Group

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:

• Study design and feasibility
• Start-up speed
• Country and site activation
• Patient recruitment and retention
• Site partnerships and vendor collaboration
• Data quality and inspection readiness
• Leadership choices that move the needle 

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.