First in Human
From CTA-enabling to FiH/Early Stage studies, delivered with precision
First-in-human is where science meets operational reality. CR2O has delivered 120+ clinical studies across novel modalities and complex mechanisms — with a Phase I unit network, medical monitoring bench and regulatory expertise to match.
Explore
Inside a CR2O FiH/Early Stage program
CTA / IMPD preparation
Regulatory writing and strategy to get you to the clinic.
- IMPD, IB and briefing books authored by scientists
- Scientific advice meetings with EMA / national agencies
- Cross-referenced with your CMC and preclinical package
Site & unit selection
Access to a curated network of EU Phase I units.
- Units profiled by capability, throughput and specialization
- Direct PI engagement — no gatekeepers
- Rapid feasibility with realistic timelines
Dose escalation execution
Adaptive designs, SRC coordination and real-time medical oversight.
- SAD / MAD, BE, food effect, DDI
- Independent medical monitor available 24/7
- Safety review committee coordination end-to-end
Data, reporting & next steps
From locked data to CSR and design of the Phase Ib/II follow-on.
- PK / PD analytics and biostatistics
- CSR authoring inside 8–10 weeks of last patient
- Seamless roll-through into patient studies
First in human studies
Planning a first-in-human study?
Share your target profile and we’ll return with a Phase I unit shortlist, an executable timeline, and a transparent budget.