Clinical Research – Phase I

Early-Phase Clinical Studies

First-in-human, in our own hands.

A fit-for-purpose clinical-pharmacology unit with 70 beds across 4 clinics and 25+ years of study experience.

What’s included

First-in-Human, Single & Multiple Ascending Dose (SAD/MAD)
BA/BE, food-effect, drug-drug interaction, PK/PD (healthy & patients)
Special populations: renal & hepatic impairment, elderly, metabolic syndromes; CNS assessments
On-site Phase I pharmacy (sterile prep), CLIA safety lab, diagnostics (X-ray, USG, CT/MRI, DEXA, ABPM, EMG, video-EEG), ICU with cardiac monitoring & ambulance readiness

Why CEBIS

We own and staff the unit — ~1,400 m² of clinical area, 24/7 medical oversight, and a robust male/female volunteer database that prevents cross-participation and enables fast recruitment. Our bioanalytical lab (700 m², triple-quad LC-MS/MS, 250+ validated methods) supports IND/NDA/ANDA filings, and our BE facility has been FDA-audited with zero 483 observations.