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.
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.
Structured data capture, cleaning, and biostatistical analysis leading to clear, regulatory-ready clinical study reports.
Discover Our Phase I Clinical Unit
Participate InClinical Trials
CTA, ethics submissions, and coordinated study activation.
Identification and evaluation of qualified study sites.
Safety monitoring and regulatory safety reporting.
Regulatory submissions and lifecycle compliance support.
Central coordination of study execution and timelines.
Risk-based monitoring for safety and data integrity.
Audits, compliance oversight, and inspection readiness.
