We support you with:

• Integrated early development strategy: defining the most efficient route from preclinical data to proof-of-concept, aligned with your Target Product Profile.
• Regulatory scientific advice: preparing and supporting EMA Scientific Advice, national competent authority interactions, FDA pre-IND / Type B meetings, and CTA/IND-enabling documentation. 
• First-in-human design: pharmacologically-anchored / MABEL-based starting-dose justification, dose-escalation strategy (rule-based or model-based/Bayesian), sentinel dosing and integrated stopping rules, in line with the EMA FIH guideline. 
• Adaptive & seamless designs: SAD/MAD, integrated Phase 1/1b, dose-finding and expansion cohorts to reach decisions faster. 
• Proof-of-mechanism & Proof-of-concept (Phase 1b): early signal detection in patients, with rigorous cohort and population selection. 
• Translational & model-informed support: PK/PD interpretation and exposure-response insight, delivered together with our preclinical and pharmacokinetics partners to strengthen your dose rationale. 
• Endpoint & biomarker strategy: selecting exploratory and early-efficacy endpoints that are fit for decision-making.
• Proportionate, objective-driven sizing: sample sizes scaled to the exploratory question, not to late-phase power calculations. 
• Scientific literature & competitive landscape review.