A Hands-On Approach to Global Trial Execution
Gameto is a 20-person biotech. Their clinical operations team? Just three people. Yet that trio has designed and run nine studies across Peru, Mexico, Australia, and the United States—on their own infrastructure, without a big-box CRO, and without hiring dedicated data managers. They’re now in Phase 3 in the U.S. and already have commercial access in several countries.
What makes this story worth your time is how little was outsourced. Gameto didn’t hand off trial setup to consultants. They trained embryologists during live egg retrievals, used existing site relationships for implementation, and configured studies directly in Castor. Fast, focused, and regulator-ready.
“You’d be surprised what you can accomplish when there’s no other choice.”
— Sabrina Piechota, Clinical Ops, Gameto
Study Build in Weeks, Not Months
One randomized trial in Peru went from protocol to go-live in three weeks—in Spanish. It covered patient demographics, hormone labs, embryology results, pregnancy data, adverse events, image uploads, and randomization. The build came from Castor’s documentation and helpdesk—no special training, no delays.
“We don’t have six months to set up a database. We have three weeks.”
— Christian Kramme, CSO, Gameto
Data That Passes FDA Review
A 38-patient dataset—30 Fertilo, 10 control—moved the product straight into FDA Phase 3. Clean audit trails and rapid CRF versioning kept regulators comfortable.
“We’re constantly learning, so the platform had to let us adjust on the fly without losing quality.”
— Christian Kramme
Localization Without the Bottleneck
Modular CRFs with multilingual support let the team reuse core forms while adding local fields. Most issues were spotted through direct CRF review and fixed in real time—no extra headcount required.
A Global Head-to-Head Study, Run Lean
Next, Gameto will compare Fertilo to conventional IVF in Europe, Australia, the Middle East, and Southeast Asia. Same three-person core team, same platform, bigger impact.
“We’re not trying to build a giant apparatus. We want to stay nimble, stay close to our data, and scale smart.”
— Christian Kramme
Long-Term Follow-Up Built In
Maternal safety and two-year infant development metrics are already embedded in the registry. Patients complete milestone questionnaires every six months, feeding directly into the Castor database.
Watch the Full Conversation
This article distills key points from the fireside chat between Derk Arts (Castor CEO), Christian Kramme (Gameto CSO) and Sabrina Piechota (Gameto, Embryology Department Manager). For the complete discussion—including audience Q&A—watch the on-demand webinar here:
How Gameto’s Team Built a Phase 3 Trial Engine from the Ground Up (On-Demand)
What Larger Teams Can Learn
Speed is only half the story; precision is the other. By keeping data close to the scientists and trusting a flexible EDC, Gameto shows that lean execution can satisfy regulators and accelerate timelines. For sponsors tired of bloated vendor chains, this is proof that smaller, smarter teams can win.
