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Phase 1 Clinical Trials

With 25 years of legacy, Lambda Therapeutic Research, a trusted full-service CRO, offers meticulously tailored early phase development services to align with your compound, business model, and specific study objectives.

Backed by decades of experience, our highly skilled team brings unparalleled expertise in Phase-I scientific and therapeutic domains. Over the past five years, Lambda has successfully conducted more than 40 Phase 1 Clinical trials across a diverse range of formulations, including Oral, Parenteral, Inhalers, Topical, Transdermal, Nasal Sprays, Injectables, Pessaries, Suppositories, and more.

Partner with us to ensure your early development programs are driven by precision, innovation, and reliability.

Our CPUs:

Our state-of-the-art Clinical Pharmacological Units (CPUs) in Ahmedabad (India) and Las Vegas (USA) 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 191 beds for early-phase trials
  • Dedicated 15-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) Studies

First-in-human (FIH)

Self-administration Studies

Drug-Drug Interaction, Food-Drug Interaction

Human Factor Studies

Drug-Device Combinations

PK-PD Proof-of-Concept

Biosimilars

Food effect studies

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.

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