1. Home
  2. /
  3. Phase I Clinical Trials

Phase I Clinical Trials

Our early development services are meticulously tailored to match your compound, your business model, and your study’s specific objectives. With a wealth of experience spanning over 25 years, our highly skilled team possesses unparalleled expertise in Phase I scientific and therapeutic domains. 

Lambda has successfully completed more than 40 Phase-1 studies in the past 5 years, encompassing a diverse range of formulations, including Oral, Parenteral, Inhalers, Topical, Transdermal, Nasal Sprays, Injectables, Pessaries, Suppositories, and more.

Our CPUs:

Our state-of-the-art Clinical Pharmacological Units (CPUs) in Ahmedabad (India), Las Vegas (USA), and Toronto (Canada) employ a synergistic approach across geographies, offering timeline and cost advantages. These specialized units excel in conducting early-phase studies on healthy volunteers, including special populations, across a diverse spectrum of therapeutic areas.

Ahmedabad, India:
  • Dedicated 16-bed capacity for Phase-I (FIH) studies
  • One of India's largest clinical pharmacology facilities featuring state-of-the-art infrastructure and an extensive safety set-up.
Las Vegas, USA
  • 37,000 sq ft facility
  • 4 clinics with 190 beds for early-phase trials
  • Dedicated 12-bed capacity for Phase-I (FIH) studies
  • Dedicated Outpatient/Returns clinic

Our Broad Spectrum of Phase-I Studies Includes:

Single / Multiple Ascending Dose (SAD/MAD)

First-in-human (FIH)

Bioavailability / Bioequivalence

Drug-Drug Interaction

Food-Drug Interaction

Drug-Device Combinations

PK-PD

Proof-of-Concept

Food effect studies

Vasoconstrictor and Cardiac Safety studies

Inhalation studies

Dermatology studies

NORTH AMERICA

  • FiH Or SAD study in Canada & US
  • Faster regulatory approval
  • Parallel submission for MAD study in India
  • Study starts with healthy subjects followed by patient cohorts

INDIA

  • Cost-effective option for subsequent Phase-1 studies
  • Easier Access for Renal and Liver impaired subjects study

VALUE PROPOSITION

  • Cost-effective business model (Hybrid)
  • Faster Turn Around Time
  • Global scientific overview
  • Flexible Operational approach

Let's Unveil New Therapies Together

Connect with our experts to leverage our proven track record of clinical research excellence.

Contact Now