Phase I Clinical Trial Services

Dedicated Phase I capabilities spanning first-in-human studies, PK/PD investigations, biosimilar programs, and specialized early-phase development pathways.

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Medical device clinical research
Experienced Team First in Human Trial

Phase I Research Built for Clinical Development

Precision at the earliest stage of development.

Ordoclin combines dedicated Phase I infrastructure with expertise across pharmacokinetics, pharmacodynamics, and specialized early-phase study designs. Through an integrated model encompassing clinical operations, bioanalytical sciences, biometrics, and regulatory support, studies are executed within a single operational framework designed for efficiency, oversight, and regulatory acceptance.

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  • FIH, SAD, MAD & PK/PD Studies
  • ICU-Level Phase I Infrastructure
  • Integrated Clinical & Bioanalytical Operations
  • In-House Biometrics & Statistical Analysis
  • Multi-Agency Regulatory Acceptance
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Early-Phase Expertise at Scale

Built for complex Phase I development programs.

16+

dedicated Phase-I Beds

2

Inhalation Chambers

2

Euglycemic Clamp Devices

20+

BED ICU facility

Trusted by Partner Worldwide

Experience. Quality. Confidence.

Phase I clinical research
PHASE I
STUDY TYPES

Phase I Study Type

Scientific expertise across key Phase I study models.

Our Phase I clinical trial experience spans a broad range of early-phase study models across multiple development pathways. The following are the Phase I study types conducted by Ordoclin.

01 First-in-Human (FIH) Studies
02 SAD / MAD Studies
03 PK/PD Studies
04 Food Effect Studies
05 Drug-Drug Interaction (DDI) Studies
06 Cardiac Safety / QTc Studies
07 Biosimilar PK/PD Studies
08 Special Population Studies
09 Inhalation Studies (MDI / DPI)
10 Dermatology & Topical Studies
11 Drug-Device Combination Studies (AI Pens)
12 PK-PD Proof of Concept Studies
13 Human Factors Studies

Phase I Clinical Capabilities

Capabilities designed for studies that demand precision and control.

Beyond standard Phase I execution, Ordoclin has invested in specialized infrastructure and scientific expertise that enables studies many CROs cannot accommodate.

Two dedicated negative-air inhalation chambers prevent cross-contamination from airborne drug particles. Extensive experience across MDI, DPI, and nasal delivery — including bronchodilators, inhaled corticosteroids, and combination products. Formoterol, Salbutamol, Fluticasone/Salmeterol, Budesonide/Formoterol

Specialist execution of hyperinsulinemia euglycemic and hyperglycemic clamp studies — including comparative biosimilar insulin PD clamp protocols: validated glucose assessment devices, insulin/glucose assays, and clamp-stable Phase I unit environment.

Comprehensive ECG monitoring capabilities supporting thorough QT/QTc studies in compliance with ICH E14 and associated guidance, with cardiologist oversight throughout.

Appropriately licensed and secured controlled substance study execution, including CNS agents and substances requiring specialist handling and subject monitoring protocols.

Centralized reading by subspecialty-trained radiologists for CNS and retinal imaging endpoints. Modalities include OCT, MRI, PET, CT, FA, and CFP — 10,000+ images reviewed, 600+ clinical sites in the network.

AI-assisted multi-dose pen device studies and human factors self-administration studies were designed and executed by a specialist clinical team with device-specific regulatory expertise.

Trusted by Global Regulatory Authorities

Regulatory confidence built into every study.

Phase I clinical trials conducted by Ordoclin have supported regulatory submissions across major global markets. Our clinical, bioanalytical, and data management operations are aligned with internationally recognized standards, enabling the generation of clinical data accepted by leading regulatory authorities worldwide.

GLOBAL REGULATORY ACCEPTANCE
FDA
EMA
CDSCO
Health Canada
TGA
MHRA
ANVISA
WHO

Phase I studies accepted by:

Phase I clinical trials conducted by Ordoclin have supported regulatory submissions across major global markets. Our clinical, bioanalytical, and data management operations are aligned with internationally recognized standards, enabling the generation of clinical data accepted by leading regulatory authorities worldwide.

Clinical Research Team

Why Partners Choose Ordoclin?

Where complexity becomes capability.

Clinical Research Team

Partners choose Ordoclin for its ability to combine scientific expertise, specialized Phase I capabilities, and integrated study execution within a single research environment. Our operational model is designed to support complex development programs while maintaining the oversight, efficiency, and regulatory confidence expected in early-phase clinical research.

  • Integrated Clinical, Bioanalytical & Biometrics Operations
  • Expertise Across FIH, SAD, MAD & Specialized PK/PD Studies
  • Dedicated Phase I Infrastructure with ICU-Level Monitoring
  • Broad Therapeutic Experience Across Multiple Disease Areas
  • Specialized Capabilities Including Inhalation, Clamp & QTc Studies
  • Clinical Data Supporting Global Regulatory Submissions
  • End-to-End Study Execution from Protocol to Final Reporting

Planning a Phase I Clinical Trial?

Talk With Our Phase I Team