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.
Guest
- 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
Episode Overview
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.
Key Moments
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
Top 3 Takeaways
- 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.
- 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.
- 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.
Links & Resources
Quotes
“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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