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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) 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.
- 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.
- 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.