Executive Summary
In Q2 2024, a mid-size biotech faced a high-stakes breakdown: its global Phase 3 spinal cord injury (SCI) trial had stalled, with enrollment less than halfway complete and time running out. With no viable expansion plan in place, the sponsor turned to Yendou, a Berlin-based startup founded by a former clinical operator. Within six weeks, Yendou not only rescued the trial, identifying and qualifying the right sites in Germany, Austria, and Spain, but demonstrated a repeatable, scalable model for transforming site engagement across geographies. This case study explores how Yendou deployed a structurally simple, tech-enabled system that turned chaos into control, and friction into acceleration.
Situation
In early 2024, a mid-size biotech's Phase 3 SCI trial—code-name undisclosed—was on the brink of failure. After nearly two years, only 34 patients had been enrolled, just 47% of the 72-patient target. Recruitment had stalled, even as the sponsor had projected full enrollment by December 2024. The trial's design made recruitment extraordinarily difficult: eligibility criteria were narrow, and patients had to receive the investigational therapy within 48 hours of injury.
The urgency was escalating. Every day, the sponsor's leadership team watched their enrollment window close. Failure to meet the target would delay a potentially life-saving therapy and trigger millions in sunk costs.
Existing trial sites in the US, Canada, and Japan were underperforming. Expanding to Europe—especially Germany—emerged as the final option. Yet Germany sees only ~1,400 acute SCI cases annually versus 17,000 in the US, and the sponsor had no active site network in the region. Building new hospital sites from scratch is typically slow and resource-intensive. Traditional feasibility and CRO-led models were too slow to rescue the timeline.
Complication
The sponsor faced a catch-22. They needed European patients to meet enrollment, but qualifying the feasibility of the protocol in new countries and selecting new sites using conventional methods would take 4–6 months—far beyond the trial’s LSI timeline.
Finding eligible SCI patients within 48 hours of injury was like finding needles in a haystack. Only a handful of European Level I trauma centers had the necessary research capabilities and infrastructure. The sponsor had no existing relationships with these centers, no internal data on site performance, and no fast-track option to engage investigators.
The default CRO playbook—broadcast feasibility emails, collect responses, assess manually—was too slow and too generic. The sponsor needed speed, precision, strategic insights and execution under pressure. They needed a new model.
Resolution
Instead of doubling down on conventional options, the sponsor took a calculated risk: they engaged Yendou, a Berlin-based startup focused exclusively on site engagement.
Founded in 2023 by a former sponsor-side clinical operator, Yendou was designed for this exact scenario. The founder had spent years managing feasibility workflows from the inside and had built the product around what existing systems failed to deliver: speed, transparency, and simplicity.
The connection came via a LinkedIn post. A Clinical Operations lead had shared Yendou’s thought leadership internally. It didn’t pitch. It diagnosed. And it captured the attention of leadership. Trust was established before a demo was scheduled.
The client handed Yendou a near-impossible brief:
Launch a full pre-feasibility across Germany, France, Italy, Spain, Austria, and Switzerland
Identify and qualify 10–15 trial-ready hospitals, select 6 to 7.
Deliver results in under 6 weeks
In essence, Yendou was asked to do in a month and a half what would normally take half a year.
Yendou’s approach was not just fast—it was structurally simple. Instead of relying on the sluggish, sequential steps of a traditional CRO-led feasibility study, Yendou deployed a concurrent, tech-enabled blitz—made possible by its low-friction product architecture.
At the heart of the effort was Yendou’s data-empowered site engagement platform (SEP), a first-of-its-kind platform for clinical R&D. The team fed every available data source into the system—trauma center registries, investigator publications, trial history, and proprietary research contacts—to rapidly map the European SCI landscape. Within four hours, the system surfaced a shortlist of 15+ high-potential hospitals and their KOLs.
Each interaction—from feasibility outreach to document collection—was powered by template-driven workflows, personalized messaging, and passwordless access for sites. There were no portals. No training manuals. No login fatigue. Just a straightforward interface that investigators and study staff could engage with in seconds. Behind that simplicity, Yendou’s site engagement platform recorded every response, deadline, and follow-up with precision. Powerful internally, invisible externally.
But this wasn’t a one-off. What Yendou deployed wasn’t heroics—it was a repeatable system. Every element of the engagement—from initial targeting, to protocol mapping, to CDA tracking—was built on reusable templates, smart defaults, and a feedback loop that improved with every trial. As new data entered the system, site profiles became richer, response patterns were scored, and future engagement became more efficient. Each action didn’t just serve one trial—it compounded Yendou’s internal intelligence for the next.
Within four days, 42% of targeted sites had responded. Personalized messages reached the right site contacts, responses came in through simple, branded forms, and follow-ups were automated but felt human. One investigator described the outreach as “collaborative, not transactional.” That sentiment echoed across the board.
Yendou’s SEP tracked every site’s progress—response time, documentation quality, infrastructure gaps—and used this data to generate a real-time dashboard of engagement quality, risk, and speed. Client teams could see exactly which sites to prioritize and which would stall the process. This radical transparency replaced guesswork with confidence; and allowed fast, high-quality decision-making without excess complexity.
Beyond that, Yendou organized an investigator workshop to gather protocol feedback and stress-test recruitment assumptions. Seventeen investigators contributed, helping refine site selection criteria and flag design risks. This was fed back into the system, improving qualification accuracy in real time. Every interaction wasn’t just tracked—it was leveraged.
In the background, Yendou’s automation engine handled all non-critical tasks: resending CDAs, chasing missing forms, updating site records. This ruthless focus on core value-add work allowed Yendou’s small team to scale impact across multiple countries—without burning out or growing headcount prematurely.
Execution: Simplicity at Scale
Yendou deployed a concurrent, tech-enabled blitz using its purpose-built Site Engagement Platform for clinical R&D. Every trauma center, publication, trial history, and PI record was aggregated into a real-time map of the European SCI landscape.
Within four hours, Yendou surfaced a shortlist of 37 high-potential hospitals and their KOLs.
How the System Worked:
No portals, no passwords, no training manuals. Investigators responded via passwordless links embedded in personalized outreach.
Every outreach was automated and humanized. Smart variables, templates, and KOL mapping ensured messages felt relevant, not spammed.
Real-time CRM dashboards tracked engagement, response speed, documentation status, and flagged delays proactively.
Templates powered every action. CDAs, site briefs, and feasibility forms were reused, adapted, and sent at scale.
Within four days, 42% of sites had responded. Within two weeks, pre-qualification calls were completed. By week six, the client had a vetted, trial-ready site network in three countries.
Importantly, this wasn’t a one-off.
Every piece of data—site responses, PI preferences, form history, timelines—was linked to the site profile and reused. The platform improved with every study. Yendou had built not a team of heroes, but a compounding system.
Impact
The results were undeniable. In just 17 days, Yendou completed what traditionally takes 3 months: identifying, evaluating, and engaging the right German sites. Within six weeks, they had qualified hospitals in Germany, Austria, and Spain, ready to activate. By Q2 2025, the trial was back on track, with 12.5% of total enrollment sourced from Yendou-selected sites. What had been a failing trial was now pacing toward full enrollment.
What Made the Results Repeatable
Template-Driven Execution: Every outreach, form, and briefing document was generated from reusable components tailored to SCI and study needs. The system adapts across indications.
Compounding Site Intelligence: Every site record was enriched, scored, and tagged for reuse—future trials benefit automatically from prior engagements.
Simplicity at Scale: By stripping out portals and manual rework, Yendou removed the bottlenecks that prevent scaling. The more studies run through the system, the faster the next wave moves.
Customer Fit as Architecture: The platform wasn’t designed for enterprise IT teams. It was built for 3-person feasibility units and 8-country SMOs. That constraint shaped the simplicity—and the adoption.
The Disruption is Structural
Most platforms try to digitize what CROs already do, Yendou replaces it with a modern alternative, that empowers Sponsor and CRO execution:
Lessons Learned
Leverage Data to Drive Speed: This case highlights that harnessing data and technology can compress timelines in ways previously thought unattainable. A data-driven site engagement platform enabled Yendou to extract insights (e.g., where the right infrastructure and investigators were) in hours, not months, which was pivotal to success. In complex trials, investing in tools that surface the right targets quickly can be the difference between meeting enrollment or missing it.
Agility and Focus Beat Bureaucracy: Yendou’s elite execution underscores the power of a small, focused team operating with startup agility. By cutting out red tape and working in parallel streams (rather than the slow stepwise traditional process), they achieved in 6 weeks what often takes 6 months. In time-critical projects, a “ruthless efficiency” mindset – where every action is aligned to the end goal and non-essentials are eliminated – can dramatically accelerate progress.
Engage the Right Stakeholders Early: The study rescue demonstrated the importance of engaging key opinion leaders and site staff from the outset. By mapping and reaching KOLs and motivated investigators directly, Yendou built buy-in and momentum quickly. Even in a scarce patient population, a high engagement rate is possible when you present a compelling opportunity to the right people. The lesson for sponsors is to cultivate networks (or partner with those who have them) before a crisis hits – relationships and local knowledge are invaluable in a pinch.
Rethink Traditional Models: Perhaps the biggest takeaway is that disruptive innovation can revitalize projects where conventional approaches falter. When a standard CRO-led process was too slow for the client’s study, the client learned that partnering with a specialized, tech-enabled firm like Yendou could yield far superior results. This doesn’t mean throwing out traditional operating models entirely, but it shows the value of staying open to new approaches. In an era when site selection and qualification can consume 6+ months of a trial’s duration and impact timelines further down the road, embracing novel solutions and breaking the mold can translate to huge competitive advantages – in this case, saving both time and money, and ultimately getting a critical therapy to patients faster.
Conclusion
Yendou turned a failing trial into a recoverable one, not by working harder, but by working differently. This case shows what happens when founder-led insight meets executional excellence, and when platforms are built not just to automate, but to enable and compound. The CRO model isn’t broken. But for many trials, it’s no longer sufficient to ensure sponsors' success.
Yendou didn’t just beat the timeline. It rewrote it.
If this resonates with your challenges, email Alex, our account manager, at alexander@yendou.com or book a demo here.