EARLY - PHASE CLINICAL RESEARCH

In-House BA/BE

Clinical Trials

Based in the European Union, fully GCP compliant, with a dedicated Phase I unit of up to 72+ participants.

CRS conducts in-house Bioavailability (BA) and Bioequivalence (BE) studies within its dedicated clinical research unit, providing sponsors with an efficient and controlled setting for comparative pharmacokinetic evaluation. Our infrastructure and operational model are designed to support both regulatory-driven BE programs and exploratory BA assessments with high precision and consistency.

We support a wide range of BA/BE study designs, including single-dose and multiple-dose crossover studies, fasting and fed conditions, and replicate designs where required. Careful attention is given to dosing accuracy, washout periods, and protocol-defined timing to ensure reliable and reproducible pharmacokinetic data. All study activities are performed under medical supervision in accordance with Good Clinical Practice.

CRS manages the complete conduct of in-house BA/BE studies, including volunteer recruitment, screening, dosing, inpatient stays, outpatient visits, and intensive pharmacokinetic sampling. Our unit is experienced in handling dense sampling schedules and strict time-point adherence, which are critical for robust comparative analyses.

Clinical operations are closely coordinated with bioanalytical laboratories, data management, and statistical teams to support accurate data handling and timely analysis. Quality control measures are embedded throughout study conduct to ensure data integrity and regulatory acceptability.

By combining dedicated facilities, experienced operational teams, and integrated clinical services, CRS delivers BA/BE studies that support confident regulatory submissions and informed product development decisions.
Request For Proposal
  • Ethics Committee approval for all studies
  • Regulatory strategy and regulatory submissions
  • Study start-up and site activation
  • Clinical trial planning and study design
  • Clear participant information and informed consent
  • Conducted in compliance with ICH-GCP and EU regulations
  • 24/7 safety monitoring and emergency readiness
  • Qualified investigators and trained study teams
  • Confidential handling of participant data

20+ Years

Of Experience in Early-Phase Clinical Research

Phase I Unit

Infrastructure organized across two dedicated units for controlled inpatient studies

EU Certified CRO

Slovenia, European Union regulatory environment

GCP Compliant

Conduct under international quality standards