The COG Review: Building Better Clinical Studies

Learn how small biotech’s can streamline clinical trial outsourcing, optimize CRO selection, and establish truly patient-centered operations for rare disease studies—while maintaining high data quality and speed.GuestJurate Lasiene, VP Clinical Operations, North Sea TherapeuticsLinkedIn: Jurate LasieneEpisode OverviewThis episode of The COG Review: Building Better Clinical Studies is recorded live at COG Europe in Amsterdam. Jurate Lasiene, VP Clinical Operations at North Sea Therapeutics, shares firsthand insights from managing a first-in-human, early-phase rare disease trial with a small, agile biotech team. The session explores critical decision points and real-world solutions in clinical trial outsourcing, CRO selection, and effective sponsor–vendor collaboration.Key topics include designing adaptive, patient-first protocols for challenging rare disease populations, the shift from traditional full outsourcing models to targeted FSP (Functional Service Provider) or hybrid approaches, and optimizing budget, speed, and quality by retaining operational control in-house where it matters most. Jurate Lasiene offers a practical breakdown of site and partner selection, early regulatory and KOL engagement, and hands-on clinical operations best practices.This episode equips clinical research professionals in biotech, pharma, and CROs with actionable frameworks for clinical study optimization—especially useful for those navigating complex trials with lean teams and limited resources. Listeners gain concrete guidance on the sponsor-side leadership choices and process refinements that reduce common failure points and accelerate study timelines.Key Moments00:01:40 – The unique operational challenges of rare disease trials: small, dispersed patient populations and high rates of trial discontinuation00:03:41 – Why small biotech’s are driving the majority of clinical trial starts and how their outsourcing strategies have evolved00:04:31 – Clinical trial protocol design: avoiding rigid endpoints and restrictive eligibility to improve enrollment and retention00:05:16 – The necessity of integrating patient and caregiver input early for truly patient-centered clinical trials00:06:45 – How to select clinical trial sites: speed, fit, and operational capacity versus academic prestige00:08:31 – Practical cost-savings from targeted FSP models: 30% budget reduction by outsourcing only specialty capabilities00:10:23 – Engaging KOLs and patient advocacy groups at the protocol development stage for better outcomes00:11:41 – Keeping oversight in-house with dedicated monitors/PMs: advantages for quality and site engagement00:13:27 – Building a “meshwork” of specialist partners to keep small teams agile, responsive, and in control00:16:46 – Simulating the patient journey to optimize protocol, logistics, and site operations for clinical study optimizationTop 3 TakeawaysEarly and deep integration of clinical operations into trial and protocol design is essential for avoiding downstream roadblocks—making this a core clinical operations best practice.Targeted outsourcing and deliberate CRO selection (favoring fit and flexibility over scale alone) enables small teams to maintain control, ensure sponsor oversight, and optimize budgets.Mapping the exact patient (and caregiver) journey—through direct simulation and advocacy group...

Discover operational strategies to move beyond traditional clinical trial outsourcing—learn how the clinical mesh approach can optimize study speed, oversight, and cost efficiency for today’s clinical operations leaders.GuestMaria Expósito Lorido (LinkedIn)Venture Partner, Vu Venture PartnersExtensive experience in clinical development, clinical trial outsourcing, and operational leadership within pharma/biotechEpisode OverviewThis live session from COG Europe in Amsterdam features Maria Expósito Lorido, a leading venture partner with hands-on experience designing and implementing innovative clinical outsourcing strategies. Maria offers a compelling presentation shifting the conversation from conventional CRO selection and outsourcing models to a new paradigm: sponsor-led orchestration through the clinical mesh playbook.Listeners gain practical guidance on clinical operations best practices by contrasting traditional outsourcing with platform and ecosystem-based models. Maria reveals why most studies fall short on recruitment, what it costs, and how an orchestrated mesh of specialized partners can reduce delays and increase value for sponsors and patients alike.Specific areas covered include how to tailor sourcing architecture to your study’s needs, which operational components to retain or externalize, and ways to apply clinical study optimization principles for faster, more flexible trial delivery. The episode also addresses implementation steps, measurable KPIs, and critical sponsor responsibilities in this emerging model.Ideal for clinical operations, outsourcing managers, and vendor strategy professionals seeking to future-proof their approach to CRO selection and clinical trial outsourcing.Key Moments00:03:00 – Why 80% of clinical studies miss recruitment targets and the financial impact of delays00:05:00 – Comparing small, agile biotech teams vs large pharma R&D models for clinical trial delivery00:06:55 – The Nvidia platform analogy: platform business models vs linear development pipelines00:07:10 – Introduction to the “clinical mesh” model: moving from fixed structures to reconfigurable networks00:08:33 – Three sourcing architecture types—full-service CRO, functional service provider, and clinical mesh—and when each works best00:11:23 – Governance challenges and sponsor responsibilities under the mesh model00:14:04 – Early-stage oncology case study: cost, timelines, and screen failure rate compared across outsourcing models00:16:27 – Quality management, risk, and safety oversight: what sponsors must own when orchestrating a clinical mesh00:18:57 – KPIs for clinical study optimization: measuring cost per qualified patient, time to first contact, and more00:19:43 – 90-day roadmap for piloting a clinical mesh approach with stepwise best practicesTop 3 TakeawaysOrchestrate, don’t just outsource: Sponsors retain strategy, quality, and data oversight even when leveraging a network of specialized vendors—this increases flexibility and operational control compared to traditional outsourcing.Match sourcing architecture to study needs: Evaluate each study to determine the best-fitting sourcing model (full-service CRO, hybrid/FSP, or clinical mesh), rather than defaulting to a single approach for all trials.

Navigating Global Clinical Trial Outsourcing: Risk, Strategy & CRO Partnerships in a Changing WorldGain 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.GuestHeike Schoen, CEO, Loomis International (LinkedIn)20+ years in clinical operations, global trial strategy, and vendor managementBart Scheerder, HostAuthority in European clinical operations and outsourcing trendsDavid Jones, Head of Content, The PBC GroupRecorded live at COG Europe, Amsterdam.Episode OverviewThis episode of The COG Review: Building Better Clinical Studies features Heike Schoen, CEO of Loomis International, in a keynote session from COG Europe. The discussion centers on the global shift in clinical trial outsourcing, with a sharp focus on how sponsors and CROs are adapting to rapid changes in regulation, geopolitics, and technological innovation.Heike Schoen explores the evolution of sponsor–CRO partnerships, from transactional service agreements to nuanced hybrid models, where flexibility and deep therapeutic expertise are essential for success. Practical examples from Novartis–PPD and Moderna–Medidata illustrate both functional service partnerships and the impact of digital, decentralized trials.Key areas include CRO selection strategies for emerging markets, navigating regulatory changes, and building operational agility in the face of supply chain fragility and geopolitical risk. Insights are tailored for professionals involved in clinical operations best practices, outsourcing decisions, and those seeking to optimize clinical studies through smarter partnerships and technology use.The session closes with real-world challenges and live audience questions on how to structure outsourcing models, respond to regulatory shifts, and future-proof location choices for clinical trials.Key Moments00:03:37 – Global clinical trial outsourcing market growth and drivers00:04:45 – The rise of hybrid CRO partnerships: strategic alliances vs. modular models00:06:06 – Digital platforms and AI: boosting operational efficiency in decentralized trials00:07:00 – CROs must demonstrate deep therapeutic expertise and flexible service models00:08:15 – Geographic diversification: assessing emerging markets for clinical study optimization00:10:06 – AI’s impact on CRO value pools: standardization and resource allocation00:12:09 – Comparative advantages of clinical outsourcing in the US, Asia-Pacific, Europe, Latin America, Africa, and the Middle East00:14:24 – Geopolitical risks in outsourcing: contingency planning for disruption and instability00:16:08 – Supply chain fragility and cross-border data management: lessons for clinical operations best practices00:18:10 – Key drivers for outsourcing strategy: cost pressure, patient diversity, regulatory speed00:19:49 – Location strategy essentials and what sponsors should expect from CROs00:24:29 – Guidance for small biotechs on engaging CROs and designing flexible outsourcing modelsTop 3 TakeawaysHybrid CRO partnership models are becoming standard—sponsors should seek partners who can offer both full-service and functional...

Pipeline Strategy: Balancing Science, Feasibility, and ROI in Clinical Development DecisionsWhat 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 LeaderFeaturing:• Raj Patel, Chief Operating Officer, ReacX Pharmaceuticals• Nikhil Dube, Lifecycle Management Strategy Lead, Biogen• Mukhtar Ahmed, Director, Project and Portfolio Strategy, Greenstone BiosciencesRecorded 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:Balancing science, feasibility, and business drivers in pipeline advancement decisionsManaging cross-functional alignment across R&D, clinical operations, and commercial teams for better governanceThe critical role of financing, investor expectations, and real-world feasibility in CRO selection and vendor managementKey Moments00:03:20 – 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...

AI Integration in Clinical Trial Outsourcing: Best Practices for Operational Efficiency and CRO SelectionLearn 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:Paulius Ojeras, Head of Clinical Operations, Perceive Biotherapeutics (LinkedIn),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 Moments00:02:43 – Why the real question isn’t if AI will disrupt clinical trials, but how smart and fast sponsors will adopt AI solutions00:05:00 – Breakdown of AI integration levels: from basic automation to autonomous, agentic AI teammates in clinical operations00:09:47 – Case study: Applying AI agents to TMF management—quality gains and lessons from real deployment at Perceive Biotherapeutics00:13:43 – AI-driven QC finds up to 25% errors in TMF documentation, challenging norms in clinical trial outsourcing00:15:13 – Real-time document feedback and task tracking—how automation improves speed and regulatory compliance00:18:11 – Vendor selection due diligence: key criteria for assessing AI-focused clinical trial outsourcing partners00:21:31 – Addressing the challenge of outcome consistency: why it’s critical for regulated clinical trials and CRO selection00:24:38 – Rethinking process design for end-to-end automation, not just adding tools to legacy workflows00:25:37 – The importance of training internal teams for AI literacy and prompt engineering to maximize value from technology00:26:31 – Final guardrail: Success depends on thoughtful, disciplined AI adoption—not just speed or hypeTop 3 TakeawaysPrioritize 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.Redesign processes for automation: For clinical operations best practices, rethink workflows to fully leverage AI agents—instead of layering automation on top of manual...

Embedding the Patient Voice: Best Practices for Patient Engagement in Clinical Trial OutsourcingDiscover how integrating meaningful patient engagement strategies throughout clinical trial outsourcing can drive study optimization, reduce recruitment delays, and create more inclusive, effective clinical research.GuestLisa LeaDirector of Patient Insights, MerckOver 20 years of biotech and clinical expertiseSpecialist in pulmonary arterial hypertension and patient-centered trial designLinkedInEpisode OverviewThis 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:The regulatory evolution of patient engagement, with lessons for clinical outsourcing modelsOperational benefits, such as fewer delays and more relevant data through improved trial designPractical methods for embedding patient voice in trial protocols and vendor collaborationThis 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 Moments00:02:45 – Defining “patient engagement” and why it matters for clinical trial operations00:03:59 – The real-world operational risks of omitting patient voice: recruitment shortfalls and study delays00:06:55 – Historical drivers: How patient advocacy reshaped regulatory expectations and clinical outsourcing approaches00:08:08 – Balancing patient risk–benefit preferences in protocol and CRO/vendor collaboration00:09:07 – Impact of patient engagement on diverse recruitment, site selection, and CRO performance00:10:42 – Actionable steps: Where and how to embed patient insights in the clinical development and outsourcing pathway00:13:03 – Real example: Protocol design oversights leading to lost sites, and learnings for sponsor–CRO study teams00:14:40 – Participants’ desire for real influence, not token feedback—building feedback loops for operational improvement00:16:09 – Key regulatory guidances and industry resources for patient-centric trial design and clinical outsourcing decisions00:17:15 – Overcoming practical barriers: Internal advocacy, framework creation, and...

Optimising Stakeholder Engagement: Clinical Trial Outsourcing, CRO Selection, and Delivery Best Practices with Kimberly GuedesDiscover 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.GuestKimberly GuedesVice President, Clinical Operations, Intensity Therapeutics30+ years’ experience in global drug development across preclinical to Phase IV studiesLeader in process improvement, vendor management, and clinical operations strategyLinkedInEpisode OverviewRecorded 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:The dynamics of stakeholder collaboration in clinical outsourcing modelsCriteria for effective CRO selection and ongoing governanceMethods for bridging communication gaps and achieving clinical study optimisationHandling team changes, fostering trust, and responding to practical constraintsThis episode is designed for those seeking proven clinical operations best practices to help accelerate timelines, improve outsourcing partnerships, and enhance delivery outcomes.Key Moments00:03:20 – Defining stakeholder engagement in the context of clinical trial outsourcing and delivery00:04:11 – Understanding unique perspectives and constraints of sponsors, CROs, vendors, sites, and patients00:05:09 – Building predictability and trust through early, honest communication00:06:54 – Risks of poor engagement: delays, rework, low morale, and project failure00:08:02 – The importance of joint project planning and cross-functional team training00:10:03 – Creating a culture of mutual respect, transparency, and recognition with partners00:12:03 – Establishing clear roles, responsibilities, and governance for effective CRO/vendor partnerships00:14:56 – The impact of understanding team members' strengths, backgrounds, and communication styles00:18:16 – Shifting from reactive blame to collaborative problem solving in clinical operations00:19:26 – Empowering all stakeholders to ask questions and contribute new ideas for study optimisation00:27:15 – Best practices for engaging remote or distributed teams in clinical outsourcing deliveryTop 3 Takeawaysli...

Better trials. Fewer delays. Improved outcomes.  The COG Review: Building Better Clinical Studies brings you the strongest sessions from the COG meeting series, recorded on site and selected for what helps teams move now. Senior leaders, study owners, and problem solvers share what works so effective treatments reach patients sooner.  What you will hear across the season:Study design and feasibilityStart-up speedCountry and site activationPatient recruitment and retentionSite partnerships and vendor collaborationData quality and inspection readinessLeadership 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.