Design and conduct of first-in-human, single and multiple dose studies in healthy volunteers or selected patient populations.
Safety-driven first-in-human trials with intensive medical monitoring and real-time data review for early decision making.
Structured single and multiple ascending dose studies to characterize safety, tolerability, and pharmacokinetics.
Bioavailability and bioequivalence trials for generics, reformulations, and fixed-dose combinations in line with EMA guidance.
Pharmacokinetic and pharmacodynamic investigations with intensive sampling, controlled conditions, and expert analysis
Hybrid early-phase designs to accelerate proof-of-concept and support regulatory and development decisions.
Support for protocol development, ethics and authority submissions, and regulatory interactions in the EU.
Structured data capture, cleaning, and biostatistical analysis leading to clear, regulatory-ready clinical study reports.
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