Merging Science, Compliance, and Decades of Biosimilar Expertise
Phase I clinical research is the foundation of every successful drug development program—determining a compound’s safety, pharmacokinetics (PK), and pharmacodynamics (PD) before moving forward into larger trials. At our state-of-the-art Phase I unit, located in the heart of a tertiary university hospital, we provide the ideal environment for conducting early-phase clinical trials with unmatched scientific rigor and regulatory compliance.
As pioneers in biosimilar clinical development, we bring over three decades of expertise in designing and executing PK/PD studies, ensuring the generation of high-quality, regulatory-compliant data for accelerated approvals.
Why Choose Our Phase I Clinical Research Unit?
Seamless Integration with a Leading University Hospital
- Immediate access to top-tier medical expertise → Our close collaboration with hospital specialists enables real-time patient monitoring and intervention if needed.
- Advanced diagnostic capabilities → Leverage state-of-the-art imaging, bioanalytical, and laboratory infrastructure.
- Regulatory-compliant clinical setting → All trials adhere to ICH-GCP, EMA, and FDA guidelines for the highest standards of patient safety and data integrity.
Unrivaled Biosimilar Expertise – 30 Years of Leadership
Pioneers in biosimilar PK/PD trials – We have successfully conducted early-phase studies for leading biosimilar manufacturers, helping them navigate the complex regulatory pathways in the US and Europe.
Data-driven decision-making – Our robust bioanalytical capabilities and in-depth PK/PD modeling ensure accurate dose selection and clinical comparability.
High-Quality Data Delivery for Faster Regulatory Approvals
- Rapid study start-up & recruitment → Our proximity to a university hospital grants access to a diverse pool of healthy volunteers and patient populations.
- Comprehensive PK/PD data collection → Advanced biomarker analysis, pharmacokinetic modeling, and immunogenicity testing tailored to biosimilar regulatory requirements.
- Regulatory liaison support → We assist in preparing IND, IMPD, and biosimilar submission dossiers for seamless interactions with FDA, EMA, and MHRA.
Phase I Capabilities at a Glance
| Capability | Our Strengths |
| Study Designs | First-in-Human (FIH), SAD/MAD, Bioavailability, Food Effect, Biosimilar PK/PD, Drug-Drug Interaction (DDI), Immunogenicity |
| Therapeutic Areas | Oncology, Autoimmune, Cardiovascular, Infectious Diseases, Endocrinology |
| Biomarker Expertise | Cytokine profiling, Pharmacodynamic endpoints, Immunogenicity testing, Target engagement assays |
| Regulatory Support | IND/IMPD submission, FDA/EMA consultation, Interchangeability guidance |
| Bioanalytical Methods | LC-MS/MS, ELISA, Flow Cytometry, NGS-based assays |
| Clinical Trial Models | Adaptive design, Bayesian modeling, Real-world evidence integration |
Whitepaper Exclusive: The Role of PD Biomarkers in Biosimilar Development
Want to learn more about how PK/PD biomarkers accelerate biosimilar approvals?
Download our latest whitepaper on Pharmacodynamic Biomarkers and discover how cutting-edge approaches can optimize your biosimilar development strategy.
Final Takeaway
With our hospital-integrated Phase I unit, 30+ years of biosimilar expertise, and regulatory-grade PK/PD data capabilities, we offer a best-in-class solution for sponsors seeking rapid and reliable early-phase clinical trials.
Let’s accelerate your biosimilar’s journey to approval!
