Discover operational strategies to move beyond traditional clinical trial outsourcing—learn how the clinical mesh approach can optimize study speed, oversight, and cost efficiency for today’s clinical operations leaders.

Guest

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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