Early Phase
(BA/BE and Phase I)

Unmatched Expertise, Unparalleled Capacity

Bioavailability (BA) and Bioequivalence (BE) studies are critical components of drug development, ensuring that medications are absorbed at the intended rate and extent — and that different formulations deliver the same therapeutic effect.

At Cliantha, we specialize in conducting Bioavailability (BA) - Bioequivalence (BE) studies and Phase I studies that support the development of safe, effective, and high quality pharmaceuticals and biopharmaceuticals. With years of expertise, we partner with clients to navigate the complex regulatory landscape, ensuring that every study is designed, conducted, and reported to meet global standards.

Experience

BA/BE Studies 8100+
Phase I Studies 30+
Biosimilar Studies 25+
Global Regulatory Inspections 90+
Bed Capacity 771
Volunteer Database 1.2+ million
Phase I Beds 36
Assays Methods 950+
LCMS-MS/MS System 55+

Precision research enabled by state-of-the-art clinic infrastructure

  • ✓ 300 Beds, 12 ICU Beds
  • ✓ Bioanalytical Instruments
    • 55 LC/MS/MS
    • 2 ICP-MS
    • MSD / ECL (Electrochemiluminescent) Platforms
  • ✓ 20 Bed Phase I unit
  • ✓ 65000+ healthy subjects database
  • ✓ 4 Negative pressure rooms for inhalation product dosing
  • ✓ CAP and NABL accredited Central and Clinical Lab
  • ✓ 253 Beds, 8 ICU Beds
  • ✓ 16 Bed Phase I unit
  • ✓ 35000+ healthy subjects database
  • ✓ 4 Negative pressure rooms for inhalation product dosing
  • ✓ CAP accredited Clinical Lab
  • ✓ 2 Clinical Units
  • ✓ 218 Beds, 8 ICU Beds
  • ✓ CAP accredited Clinical Lab

Leverage Full-Service Solutions for Early-Phase Studies

The continuously expanding pharmaceutical industry and ongoing innovations in drug development demand a high level of competence to conduct a diverse range of studies. Cliantha Research has demonstrated expertise in conducting a wide spectrum of study designs, encompassing variations in doses, dosage forms, single and double-blind designs, dose escalation trials, Glucose clamp studies, proof of concept, special population research, drug-drug interaction assessments, inhalation studies, and many more.

Early Phase Offerings

  • Single-dose
  • Multiple-dose (Steady-State)
  • Special population
  • Topical and Transdermal
  • Pulmonary
  • Special route of administration
  • Single and Multiple Dose Escalation
  • Dose proportionality
  • Food Effect
  • Drug-Drug Interaction
  • Proof of Concept
  • QTc Study

Route of Administration

Oral Solid Dosage
Oral
Injectable
Injectable
Inhalation
Inhalation
Topical Products
Topical
Nasal Sprays
Nasal
Transdermal
Transdermal
Vaginal Products
Vaginal
Rectal Products
Rectal

A Track Record of Excellence in Complex Early Phase Research

From inhalation and hormonal studies to long housing, cardiac monitoring, biosimilars, and intensive PK/PD sampling — delivering consistent, high-quality outcomes across diverse therapeutic and study designs.

Accelerated First-to-File Execution

▼

Successfully completed an Open First-to-File study with integrated global operations, delivering final analysis and report within 39 hours of last PK sample collection.

Buprenorphine Buccal Film: Complex Phase I Study with Intensive Safety Monitoring

▼

Executed Buprenorphine Buccal Film study involving controlled cheek-pouch dosing until dissolution (~60 minutes), continuous respiratory monitoring, scheduled ConMed administration, and intensivist oversight.

Liposomal Amphotericin B Infusion Study

▼

Managed precise 2-hour IV infusion using calibrated infusion pumps, with proactive monitoring and effective management of infusion-related reactions through controlled medical intervention.

High-Precision PK/PD Injectable Study Execution

▼

Conducted Diclofenac Sodium PK/PD study requiring ultra-frequent early sampling and real-time pharmacodynamic assessments within minutes of blood collection.

Ipratropium Bromide HFA Study in Controlled Negative Pressure Environment

▼

Successfully executed Ipratropium Bromide HFA inhalation study with intensive volunteer training and dosing in specially designed negative pressure rooms to prevent cross-contamination.

Norelgestromin + Ethinyl Estradiol patch study : Global Multi-Phase Irritation & Sensitization Study

▼

Flawlessly conducted all three phases — Induction, Challenge, and Re-challenge — of Norelgestromin + Ethinyl Estradiol patch study across US and India, enrolling 310 female subjects.

Extensive Experience in Intensive Monitoring Studies

▼

Executed 70+ studies with continuous cardiac monitoring, including advanced telemetry and safety oversight.

Long-Housing Long-Duration Study Expertise

▼

Delivered 40+ long housing studies, 50+ long washout studies, and extended residential monitoring protocols with high subject compliance.

Hormonal and Endocrine Study Expertise

▼

Successfully completed 150+ studies involving hormonal preparations, including complex safety and PK evaluations.

Clinical Research in Special Populations

▼

Conducted 40+ studies in elderly populations, ensuring enhanced safety monitoring and protocol precision.

Multiple Dose Phase I Study

▼

Executed Phase I multiple-dose placebo-controlled topical study involving 15-day continuous housing for safety and tolerability assessment.

Thorough QT (TQT) Study Capability

▼

Successfully conducted QT/QTc studies with dedicated infrastructure for 24-hour Holter and telemetry monitoring.

Sublingual Studies Demanding Frequent Blood Sampling

▼

Completed multiple Nitroglycerin sublingual tablet studies requiring frequent blood sampling and rapid PK assessment.

Biosimilar Clinical Study Experience

▼

Executed clinical studies for complex biologics and biosimilars including Darbepoetin, Enoxaparin, Pegfilgrastim, Erythropoietin, Adalimumab, and Trastuzumab.

Large-Scale Depot Injection Studies

▼

Managed depot injection studies with large subject cohorts (up to n=220) and extended ambulatory sampling periods up to 70 days.

HRIPT Studies with Large Sample Size (>200 subjects)

▼

Executed 10+ HRIPT studies having large number sample size and  involving different geographic locations.

Experience

BA/BE 400+
VASO Studies 125+
Skin Irritation and Sensitization Studies 70+
PK & Adhesion Studies 50+
New Drug Applications 50+
FIH Studies 25+
SAD/MAD Studies 20+
Food Effect Studies 5+
Phototoxicity and Photoallergic Studies 5+

Precision research enabled by state-of-the-art clinic infrastructure

  • ✓ 64 bed capacity
  • ✓ 12-bed Phase I unit
  • ✓ Volunteer Database : >6,500
  • ✓ On-Site Pharmacy with control substance license Level 5
  • ✓ 2 independent clinical units
  • ✓ 60 bed capacity & 6 bed ICU
  • ✓ 1 temperature/humidity-controlled room
  • ✓ 3 Specialized Environmental Rooms for Allergy, Dry Eye and Pollutants
  • ✓ On-Site Pharmacy with control substance license Level 5

Leverage Full-Service Solutions for Early-Phase Studies

The continuously expanding pharmaceutical industry and ongoing innovations in drug development demand a high level of competence to conduct a diverse range of studies. Cliantha Research has demonstrated expertise in conducting a wide spectrum of study designs, encompassing variations in doses, dosage forms, single and double-blind designs, Phase I (SAD, MAD, DDI) studies, proof of concept, special population research, bridging studies (PFS vs AI, PFS Vs OBI), 505b(2) studies, inhalation studies, and many more.

Early Phase Offerings

  • Single-dose
  • Multiple-dose (Steady-State)
  • Special population
  • Topical and Transdermal
  • Pulmonary
  • Special route of administration
  • Single and Multiple Dose Escalation
  • Dose proportionality
  • Food Effect
  • Drug-Drug Interaction
  • Proof of Concept

Route of Administration

Oral Solid Dosage
Oral
Injectable
Injectable
Inhalation
Inhalation
Topical Products
Topical
Nasal Sprays
Nasal
Transdermal
Transdermal
Vaginal Products
Vaginal
Rectal Products
Rectal

A Track Record of Excellence in Complex Early Phase Research

From OSD, injectables, topicals, inhalation and Biologics / Biosimilar studies to long housing, biosimilars, and intensive PK/PD sampling — delivering consistent, high-quality outcomes across diverse therapeutic and study designs.

Complex Phase I Biosimilar studies:

Abtacept (PFS Vs PFS)

▼

Successfully executed Phase I study in healthy subjects, enrolled 300 subjects in <30 days, with 98% subject retention. Long return visits (day 70)

Omalizumab (PFS Vs AI)

▼

Successfully executed Phase I study in healthy male subjects, enrolled 150 only male volunteers in <35 days, Long return visits (day 126)

Pegfilgrastim (PFS Vs AI)

▼

Timely execution of Crossover study N=180 healthy subjects

505 b (2) studies

▼

Successfully executed complex 505 b(2) study of injection versus infusion (time dependent), ultra-frequent early sampling within minutes of dosing.

Nicotine Mist

▼

Executed complex 05 period crossover Nicotine study (ODT Vs Mist), with oral assessment and rapid PK timepoints

Multiple dosing

▼

Successfully executed Multiple dose study of IR (twice a day) Vs ER (once daily).

Rotigotine TDS : Single Centre (N=280) Irritation & Sensitization Study

▼

Flawlessly conducted all three phases — Induction, Challenge, and Re-challenge — of Rotigotine patch study @ US site, enrolling 280 subjects in a day.

A full-scope partner in clinical development that accelerates your path to market

  • Study Designing
  • Medical Writing
  • Trial Master File (Electronic/Paper)
  • Clinical Services
  • Bioanalytical Services
  • Project Management
  • Clinical Data Management
  • Statistical Services
  • CDISC Data Sets (SDTM & ADaM)
  • Study Material Archival

What Sets Us Apart

  • Extensive Experience

  • Extensive Capabilities

  • State-of-the-art Infrastructure

  • Regulatory Compliance

  • Global Inspections

  • Volunteer Database

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TRIAL WITH SCIENTIFIC EXPERTS

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