EARLY - PHASE CLINICAL RESEARCH
Supporting Phase I Clinical Studies in healthy volunteers
through a dedicated EU unit.
Based in the European Union, operating a dedicated Phase I unit aligned with applicable GCP and regulatory requirements.
In-patient Beds for
Healthy Volunteers
GCP-Aligned
Processes
Years of
Experience
Participants
Database
Early-phase clinical studies in healthy volunteers, including single and multiple ascending dose designs.
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 pilot studies supporting early decision-making and development planning.
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.
Support for protocol development and medical writing aligned with EU and ICH-GCP requirements.
Coordination of ethics committee and regulatory authority submissions in accordance with EU requirements.
Quality system support appropriate for early-phase clinical studies conducted within the European Union.
Central study coordination ensuring aligned timelines, clear responsibilities, and consistent execution across all study activities.
Day-to-day site operations supporting participant screening, study conduct, and inpatient study activities in accordance with the protocol.
Ongoing sponsor communication and reporting to ensure transparency, timely updates, and alignment throughout study conduct.
