The COG Review: Building Better Clinical Studies

Discover the operational frameworks and real-world considerations for implementing basket and umbrella trials in rare disease, enabling faster, more efficient clinical trial outsourcing and improved CRO selection strategies.

• Nerissa Kreher, MD, MBA
• Chief Medical Officer, Alltrna
• LinkedIn
• Extensive experience in rare disease drug development, clinical operations leadership, and innovative trial design.

Recorded live at COG New England, this session features Nerissa Kreher, Chief Medical Officer at Alltrna, in conversation with David Jones, Head of Content at The PBC Group. The discussion centers on the application of master protocol designs, basket, umbrella, and platform trials, in optimizing clinical operations for rare disease studies.

The episode addresses the persistent challenges in rare disease R&D: small and heterogeneous patient populations, restricted clinical data, and the inherent barriers to traditional country- and site-level trial models. Nerissa Kreher provides clear definitions of trial types and outlines how operational efficiencies and cross-functional collaboration can be achieved through well-structured master protocols, which have seen broad adoption in oncology but remain underused in rare disease.

Key topics include the use of shared control arms to reduce patient numbers, leveraging biomarker-defined cohorts for more targeted studies, and real-world applications of innovative trial designs which are shaping new models for clinical trial outsourcing and clinical study optimization. Hear practical frameworks and candid examples, with a focus on what needs to change operationally across sponsors, CROs, and regulatory interfaces to unlock these efficiencies.

This session is essential listening for professionals in clinical operations, CRO/vendor management, and clinical development strategy, providing a toolkit for evaluating master protocols and refining CRO selection criteria for rare disease programs.

00:01:19 – Essential constraints in rare disease: implications for feasibility, trial design, and clinical trial outsourcing

00:03:19 – The impact of genotypic and phenotypic heterogeneity on CRO selection and study start-up in rare indications

00:05:06 – The case for moving beyond “one trial per disease”: operational inefficiency in traditional models

00:06:34 – Clear definitions and trade-offs between platform, basket, and umbrella trial designs for sponsors and CROs

00:07:01 – How shared control arms reduce patient burden and streamline clinical study optimization

00:09:05 – Underuse of basket trials in rare disease: key barriers and opportunities for innovative clinical outsourcing

00:12:18 – Real-world example: efficiently enrolling multiple rare immune-mediated diseases under a single protocol

00:14:04 – Framework for umbrella INDs: template-based approaches for rapid therapy development in ultra-rare settings

00:18:09 – Statistical and regulatory efficiencies: leveraging concurrent evidence generation and shared INDs

00:21:12 – Platform technology designation: implications for vendor partnerships, manufacturing, and regulatory submission efficiency

00:26:41 – The need for biomarker validation, cross-functional collaboration, and adaptive design in rare disease clinical operations

1. Master protocols offer concrete operational efficiency
2. Converging studies through basket and umbrella designs allows for single INDs, shared sites and data, and streamlined CRO selection, resulting in faster start-up and reduced patient burden across rare diseases.
3. Shared control arms and biomarker-defined groups improve both patient experience and clinical study optimization
4. Pooling patients and endpoints through robust master protocols delivers more statistical power in diseases where sample sizes are inherently limited, driving better outcomes for both sponsors and clinical outsourcing partners.
5. Successful rare disease trials require proactive stakeholder engagement
6. Cross-functional collaboration, including patient advocacy, academia, and vendor alignment, is fundamental for effective trial execution, regulatory navigation, and future-facing clinical operations best practices.

• The PBC Group: Events and Resources Clinical Outsourcing Group meetings, agendas, and content library.
• NORD: Master Protocols in Rare Disease Systematic reviews and scientific resources on platform and basket trial design.
• FDA – Platform Technologies for Drug Development Guidance and updates on regulatory innovation relevant to master protocols.
• Alltrna Biotech Details on emerging tRNA therapies and clinical strategy.

“Aggregating patient populations across shared molecular backgrounds allows for efficiency across every step of drug development.”

“If you have a shared control arm instead of multiple for each therapy, you can see how that reduces sample size, and speeds decision making.”

“We’re still not utilizing basket trials in rare disease as broadly as we could. The operational and regulatory barriers are significant, but the need for change is clear.”

“Instead of a disease-by-disease approach, a master protocol enables a single IND across multiple conditions, with concurrent evidence generation and tangible benefits for patients and sponsors.”

“Continued advancements will require collaboration: patient advocacy groups, CROs, sponsors, academia, regulatory bodies, all working to validate biomarkers and optimize adaptive trial designs.”

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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

Discover how to move beyond inherited outsourcing templates and intentionally design operational models that fit your trial’s priorities, improving speed, oversight, and cost control in clinical operations.

• Bianca Fajardo
• Director of Clinical Operations, Functional Services Group, Premier Research
• LinkedIn

Recorded live at COG New England, this session features Bianca Fajardo, Director of Clinical Operations at Premier Research, sharing high-value insights into clinical trial outsourcing decisions and the shift toward more tailored operational models. Drawing on over two decades in the field, Fajardo addresses a key operational challenge: most sponsor organizations inherit legacy outsourcing models instead of designing them to fit evolving trial needs.

The discussion walks through practical frameworks for clinical outsourcing - from leveraging the RFP process as a design dialogue rather than a simple price exercise, to using a “soundboard” approach to weigh competing priorities like speed, cost, oversight, and geography. Bianca presents real-world examples of hybrid delivery in action, highlighting trade-offs and how to architect models that flex with program needs.

Designed for professionals managing clinical trial outsourcing, vendor management, and CRO selection, this session offers concrete best practices that can be implemented across sponsor, CRO, and clinical service teams. Whether you work on study startup, country/site activation, or portfolio-level oversight, you'll find operational strategies for clinical study optimization that are focused, actionable, and relevant amid growing complexity and new technology adoption.

00:02:21 – Why most clinical teams default to legacy outsourcing models instead of intentional design

00:04:00 – The role of organizational habit and RFP constraints in narrowing outsourcing options

00:05:29 – Soundboard analogy: how to tune operational models for speed, cost, oversight, capacity, and geography

00:06:44 – When and why to prioritize speed, cost control, or scientific oversight during clinical trial vendor selection

00:09:39 – Moving from selecting predefined models to assembling customized hybrid solutions

00:10:40 – The importance of sponsor self-reflection before entering the RFP process for clinical outsourcing

00:13:01 – Reframing the RFP as a design conversation to co-create an operating model with your CRO

00:14:24 – Concrete examples: modular and region-specific hybrid models for global clinical studies

00:18:42 – Mitigating added complexity in hybrid outsourcing models through proactive coordination and clear oversight

00:24:35 – Why strong partnership, transparency, and upfront collaboration set clinical trials up for success

1. Intentional Design Drives Value
2. The most effective clinical trial outsourcing models are engineered—not inherited. Start by clarifying study priorities, then design the operational mix accordingly rather than defaulting to templates.
3. Transform the RFP Process
4. Use the RFP as the foundation for a design conversation, not just a price comparison. Early, candid dialogue about sponsor needs and capabilities leads to better CRO selection and clinical operations best practices.
5. Hybrid Doesn’t Mean Complicated—If Well-Structured
6. A hybrid approach requires careful up-front planning and partnership but can replace downstream inefficiencies. Matching model components to program realities enables true clinical study optimization.

• COG Event Series and Agenda
• Explore upcoming meetings, curated session line-ups, and global events for clinical operations and outsourcing leaders.
• Premier Research
• Information on clinical operations, functional service provision, and partnership models.
• COG Blog: CRO Selection and Clinical Outsourcing Playbooks
• Articles and frameworks on clinical trial vendor management, RFP design, and best practices in outsourcing.

“Most often, we think we’re selecting our outsourcing models, but in reality, we’re inheriting them—defaulting to legacy processes and partnerships.”

“Instead of asking ‘Which model should we use?’ the better question is ‘What are we optimizing for in this trial?’”

“The RFP process shouldn’t just be transactional. It’s the perfect moment to co-create the right operating model with your CRO.”

“No single fixed model ever fits every study. Hybrid approaches, when thoughtfully designed, enable us to match operational strategy to our trial’s real needs.”

“Strong partnerships and intentional design up front do more to prevent inefficiency and delay than any ready-made template.”

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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

Discover how global sponsors and CROs can optimize clinical trial outsourcing and patient engagement in Africa by addressing cultural, operational, and regulatory complexities from day one.

• Dr. Sam Mbunya
• Global Patient Advocate; Consultant in Patient Education, Advocacy & Program Management
• Focus: Sickle cell disease, hemophilia, rare blood disorders, and cancer in African regions
• Based in Malmö, Sweden; Active in global project collaborations (US, Kenya, African universities)

This session, recorded live at COG Nordics, features a practical fireside chat with Dr. Sam Mbunya—an experienced patient advocate and program consultant—exploring the real-world nuances of launching and sustaining clinical trial operations in Africa. The discussion moves beyond broad generalizations, highlighting how local context, community trust, and operational diligence are critical in clinical trial outsourcing and CRO selection for African sites.

Key topics include the operational and cultural barriers sponsors often overlook, such as health literacy, transport, family decision dynamics, and the legacy of previous studies. Dr. Mbunya outlines best practices for early and ongoing engagement with patient groups, community leaders, and local health systems, emphasizing why these steps are essential for both participant protection and long-term study viability.

Listeners working in clinical operations, clinical trial outsourcing, and CRO/vendor management will find actionable strategies for designing studies that respect local realities. The conversation also explores how partnerships, clear communication, and data stewardship can help sponsors and CROs avoid common pitfalls and deliver on inclusion goals—turning compliance into true community impact and clinical study optimization.

00:00:20 – Why Africa is not a single trial environment and the operational impact of country and community diversity

00:02:53 – The health literacy gap: How poor understanding of diseases and research affects trial recruitment and retention

00:04:21 – Patient “hope” vs. informed participation: Why transparent communication matters in clinical trial outsourcing settings

00:06:03 – Addressing practical barriers such as transport, family dynamics, and cultural decision-making during CRO selection and protocol development

00:08:02 – The pitfalls of a “one size fits all” approach: Communicating and customizing study materials for multilingual, multicultural settings

00:10:09 – The importance of engagement after negative outcomes: Building trust and credibility post-trial, not just during recruitment

00:12:44 – Distinguishing participants from implementers: How involving patients from the outset improves both feasibility and ethical compliance

00:16:25 – Regulatory maturity and bottlenecks: Strategies to work with local and national ethics boards for timeline and approval optimization

00:18:09 – Leveraging technology and patient advocates for scalable education and improved health literacy

00:20:02 – The role of roundtables, advisory councils, and WhatsApp groups in ongoing community dialogue and study support

00:26:04 – Top three challenges for sponsors: Open-minded protocol design, governmental engagement, and robust data stewardship

• Prioritize Early Engagement with Local Stakeholders - Integrate patient groups, community leaders, and local systems into study design and CRO selection processes well before recruitment begins to ensure buy-in, accurate feasibility, and operational alignment.
• Invest in Health Literacy and Culturally Relevant Communication - Optimize study materials and participant discussions for language, tradition, and educational context—driving true understanding, reducing risk, and strengthening clinical operations best practices.
• Treat Regulatory and Data Strategies as Core Pillars, Not Afterthoughts - Engage proactively with national authorities and invest in transparent, locally tailored data management to streamline approvals, foster trust, and enable long-term clinical study optimization at new sites.

• The PBC Group – COG Series Events & Resources
• ClinicalTrials.gov – African Trial Registry Snapshot
• Project ECHO – All Teach, All Learn Platform
• WHO – Guidance for Good Clinical Practice in Africa

“Have an open-minded approach where you look at how people live, listen to their challenges, and engage government and patient advocacy groups from the protocol stage, not after.” – Dr. Sam Mbunya

“It’s not just about recruiting fast—it’s about protecting participants, building trust, and ensuring the process starts with patients and families, not just ends with them.” – Dr. Sam Mbunya

“Data protection and ownership are critical—robust registries and transparent practices help optimize clinical trial outsourcing and build credibility.”

“There’s always this backdrop that the global north puts Africa as a one size fits all project; but the dynamics, language, and context require a fundamentally different operational approach.”

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

Copyright 2026 The PBC Group

Unlock best practices for sponsor-led decision-making in clinical trial outsourcing, with real-world insight into optimizing CRO selection, partnership models, and operational efficiency, straight from a lean biotech team navigating these choices under budget and time constraints.

• Antonio Bermejo Gomez, Chief Development Officer, Synartro
• Operational leader at a Swedish clinical-stage biotech, hands-on with direct sponsor oversight, CRO/vendor selection, and clinical trial delivery
• LinkedIn: Antonio Bermejo Gomez
• Moderator: Sverre Bengtsson, Clinical Trials Advisor

Recorded live at COG Nordics, this focused session features Antonio Bermejo Gomez, Chief Development Officer at Synartro, sharing a sponsor’s perspective on direct clinical trial management. The discussion, guided by David Jones and Sverre Bengtsson, centers on how very small biotech organizations can retain control, make more agile decisions, and achieve clinical study optimization even with limited team size and resources.

This episode addresses the core of clinical trial outsourcing: how to maximize operational efficiency, preserve sponsor accountability, and adapt CRO selection frameworks for niche or highly constrained environments. Antonio Bermejo Gomez breaks down real-world strategies for working with specialized consultants, defining sponsor versus CRO responsibilities, and ensuring transparent decision ownership throughout a trial’s lifecycle.

Listeners will hear practical insights on:

• Structuring lean teams to optimize clinical operations without traditional full-service CRO partnerships
• Balancing the roles of independent consultants, vendor partners, and in-house expertise
• Critical considerations in CRO and CDMO selection when project fit and operational transparency are business-critical

Professionals involved in CRO selection, clinical outsourcing strategy, or day-to-day study delivery will find actionable perspectives and frameworks to apply in their own clinical operations best practices.

00:02:39 – The realities of running clinical operations with only two core sponsor staff, emphasizing strict budget control and constrained capital

00:04:47 – Key principle: Sponsor dependence on external partners demands robust clinical outsourcing strategies and clear delegation

00:10:03 – Communication and transparency: Why honest dialogue between sponsor leadership and consultants is essential for small, resource-limited biotechs

00:11:16 – Decision ownership: The sponsor, not external consultants, must make and stand by major study decisions for full accountability

00:13:41 – Clinical trial delivery model: Weekly operational meetings with CRO; continuous sponsor oversight even when lacking direct experience

00:15:02 – Accelerating timelines: How a transparent, focused approach enabled rapid recruitment and completion, delivering the full trial in just seven months

00:16:49 – “Focus on what not to do”: Prioritization as the driver of clinical study optimization under budget and time pressures

00:17:12 – CRO selection lessons: Honest assessment and fit over promises, why first conversations should clarify expectations and capabilities from both sides

00:18:49 – Adaptability: Navigating late-stage process changes (e.g., syringe manufacturing) through cross-functional collaboration among sponsor, CRO, and regulators

00:22:24 – Next steps: Preparing for partnership, licensing, or fundraising as a small team based on strong clinical proof points

1. Sponsor ownership of key decisions is fundamental, successful clinical outsourcing models are built on clear accountability, not delegation of strategic calls to CROs or consultants.
2. CRO selection should prioritize honesty, project fit, and early mutual understanding, rather than optimistic capability claims; one wrong outsourcing decision can jeopardize a lean biotech’s entire clinical program.
3. Clinical operations best practices for lean teams include ruthless prioritization, knowing what not to do is as valuable as knowing what to execute, ensuring every action ties directly to data value and milestone delivery.

• The PBC Group – COG Event Series and Blog
• Synartro – Company Overview
• COG Nordics – Conference Information

“The sponsor always needs to be accountable and responsible for all the decisions.” , Antonio Bermejo Gomez

“A small team can be very efficient if everyone is comfortable with uncertainty and focused on what really matters for clinical study optimization.”

“It’s easy to say the consultant or CRO advised it, but as sponsor you must own the outcome, good or bad.”

“In CRO selection, be polite but never pretend during first discussions. You only have one shot, and a mismatch can close down the whole clinical program.”

“When you can’t do everything, knowing what not to do, and saying no to the ‘easy path’, is critical for operational efficiency in clinical trial outsourcing.”

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

Copyright 2026 The PBC Group

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.

• Nara Daubany – CEO & Co-Founder, Phaim Pharma
• Graeme Duncan – Head of Clinical Development, Neurocentrix
• Claire Herholdt – VP Clinical Operations, Levicept
• Bradley Norton – VP Clinical Operations, Gylden Pharma
• Sarah Whalley – Director Clinical Operations, Uploid Biotechnologies
• Deirdre Flaherty – VP Product Strategy & Clinical Operations, Alchemab Therapeutics
• Julia Vassiliadou – VP Clinical Operations, F2G

Recorded live at COG UK, this panel brings together senior clinical operations leaders from emerging biopharma and specialty biotech companies to share their operational realities, decision frameworks, and lessons learned in clinical trial outsourcing and CRO selection.

Panelists reveal how small, lean teams evaluate CRO fit beyond price, integrating clinical operations best practices to ensure continuity, ownership, and transparency throughout the study lifecycle. The discussion examines differences in working with small- and mid-sized CROs versus the Big Five providers, including non-negotiables in vendor selection and the impact of global studies on CRO partnership decisions.

Key questions addressed include:

• How do sponsors prioritize CRO selection criteria beyond cost?
• What practical signals indicate a CRO’s operational capacity, therapeutic expertise, and partnership mindset?
• How do sponsors manage global clinical outsourcing, regional complexity, and adapt outsourcing models for rare disease, vaccines, or novel therapeutic areas?

The session offers a real-world look at study startup, site activation, patient recruitment, and the evolving landscape of sponsor, vendor collaboration, all with a focus on clinical study optimization and actionable takeaways for operations, outsourcing, and stakeholder teams.

00:01:49 – Defining the scope: clinical trial outsourcing, vendor fit, and operational efficiency

00:09:18 – Key decision levers for study location and CRO selection, balancing funding, patient access, and regulatory challenges

00:12:18 – Sponsor “killer questions” for CROs: assessing experience, partnership, and project de-risking

00:13:29 – Site selection frameworks: the role of specialty CROs in pain and OA studies, evidence-based site/country choice

00:14:43 – Global partnerships for vaccine trials: aligning CRO selection with endemic regions and collaborative partners

00:17:29 – Rare disease clinical outsourcing: CRO global presence, therapeutic expertise, and sponsor oversight

00:21:10 – Fitting the CRO model to novel, non-traditional clinical trial designs (e.g., IVF, women’s health)

00:24:31 – Weighing small/mid-sized versus large CROs: sponsor risk, project fit, and operational agility

00:27:28 – Sponsor oversight with large CROs: importance of clear communication, consistency, and global reach

00:29:12 – Transparency and adaptive CRO selection across study phases and pivotal trials

00:31:33 – Risk-sharing and creative contracting: milestone payments, outsourcing models, and sponsor independence

00:34:34 – Panel’s “non-negotiables”: continuity, ownership, proactive risk management, and transparent relationships

• Deep partnership matters more than price in CRO selection. Sponsors should prioritize operational fit, core team continuity, and shared ownership for clinical study optimization.
• Clinical trial outsourcing models are not one-size-fits-all. Consider therapeutic complexity, geographical spread, internal capabilities, and need for oversight when choosing between small, mid-sized, or global CROs.
• Early, collaborative protocol engagement with CROs reduces downstream amendments and fosters sponsor–vendor alignment, empowering teams to manage risk and accelerate delivery.

• The PBC Group – Clinical Outsourcing Group events
• Phaim Pharma
• Neurocentrix
• Levicept
• Gylden Pharma
• Uploid Biotechnologies
• Alchemab Therapeutics
• F2G

“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

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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

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.

• Moderator: Sverre Bengtsson
• Fiona Shields, Head of UK Clinical Operations, Novartis
• Divya Chadha Manek, Director of Clinical Operations, EyeBio
• Suki Balendra , Director of Strategic Partnerships, Paddington Life Sciences
• Lucy Clossick Thomson , Head of Clinical Operations, Purespring Therapeutics
• Sarah Dealey, Director of Country & Site Operations, Biogen
• Janette Rawlinson , Patient Advocate and Research Partner, Various national/international patient organizations

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.

• 00:02 – UK clinical trial landscape: why are trial numbers up while patient recruitment falls?
• 00:04 – How conservative site targets and accountability metrics created a downward cycle in UK site enrollment
• 00:06 – Industry and NHS perspectives: site reliability, consistency, and the barriers to delivering clinical trial outsourcing at scale
• 00:09 – Site activation delays, site resourcing challenges, and why “winner” sites dominate CRO selection
• 00:12 – The role of site resources: how local limitations shape CRO/vendor selection and operational risk
• 00:14 – Linking UK’s data resources to clinical operations: innovative models and the potential for pre-screened “virtual waiting rooms”
• 00:15 – Cross-department bottlenecks in the NHS: pharmacy, imaging, IT, and their impact on sponsor/outsourcing models
• 00:20 – Accountability frameworks: how stronger governance and direct engagement are reshaping site and sponsor performance
• 00:25 – Public vs. private sites: operational differences, business-model thinking, and implications for clinical trial outsourcing strategy
• 00:34 – Phase 2/3 trial expansion and later-phase access, but persistent resource and recruitment hurdles
• 00:37 – Global benchmarking: incentives in Germany, site performance metrics (e.g. CRDCs), and lessons for UK outsourcing

1. Site Selection and CRO Selection Must Go Beyond Track Record:
2. Both industry and patient advocates agree, defaulting to the same high-recruiting “winner” sites creates systemic access barriers. Effective clinical trial outsourcing requires nuanced CRO selection and site engagement to widen participation while balancing quality and speed.
3. Operational Resource Gaps Drive Underperformance:
4. Resource and cross-functional support deficits (in pharmacy, imaging, IT) are major blockers to timely site activation and successful outsourcing outcomes. Top-performing sites, public or private, function with strong business-like governance and clear lines of accountability.
5. Collaboration and Accountability Are Key to Clinical Study Optimization:
6. Breakthroughs in UK delivery now hinge on true partnership: flexible, site-by-site support models; integrated data utilization; transparent performance measures; and shared responsibility among sponsor, site, and CRO. This is the path to accelerated timelines and sustainable clinical operations best practices.

• The PBC Group – Clinical Outsourcing & COG Event Series
• ABPI: UK Clinical Research Reports
• NIHR: Clinical Research Delivery Initiatives
• Health Data Research UK
• Novartis
• EyeBio
• Paddington Life Sciences
• Purespring Therapeutics
• Biogen

“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

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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

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.

• Joab Williamson
• VP of Operations, Faron Pharmaceuticals
• LinkedIn: Joab Williamson
• Specialty: Clinical trial operations, immunotherapy development, rare and high-risk oncology indications

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.

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

• 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.

• 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

“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

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.

• Duncan Hall
• CEO, TRI
• Experienced leader in clinical operations and technology innovation for clinical trials
• LinkedIn

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.

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.

• 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

"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

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.

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

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:

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

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

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.

"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

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.

• Jurate Lasiene, VP Clinical Operations, North Sea Therapeutics
• LinkedIn: Jurate Lasiene

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.

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

• 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.
• Targeted outsourcing and deliberate CRO selection (favoring fit and flexibility over scale alone) enables small teams to maintain control, ensure sponsor oversight, and optimize budgets.
• Mapping the exact patient (and caregiver) journey—through direct simulation and advocacy group input—prevents oversights, reduces participant burden, and improves enrollment and retention in rare disease studies.

• Rare Disease Clinical Trials Toolkit – Clinical Trials Transformation Initiative (CTTI)
• Clinical Operations Best Practice Resources—PBC Group Blog

“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