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Early phase development and Innovation
Navigate the complex landscape of early-stage drug development
Early Phase Development & Innovation
With 25 years of legacy, Lambda Therapeutic Research, a trusted full-service CRO, brings unmatched expertise in early phase development with a track record of completing over 8,000 PK/PD studies.
Our highly specialized team, comprising global experts in early phase development and clinical pharmacology, meticulously designs integrated early-phase programs. We conduct a wide array of studies, including first-in-human (FIH), proof-of-concept, bioavailability/bioequivalence (BA/BE), drug-drug interaction (DDI), biosimilar, pharmacokinetic (PK), and single ascending dose/multiple ascending dose (SAD/MAD) studies.
With advanced facilities, operational expertise, and vast development experience, we ensure precise execution of trials involving both patients and healthy volunteers, enabling informed decisions and successful outcomes for your drug development journey.
Our Distinct Approach:
Extensive expertise in conducting studies across a wide array of therapeutic areas
- Analgesics
- Anticonvulsants
- Antidepressants
- Antifungal
- Antibacterial
- Antidementia Agents
- Antimigraine Agents
- Antiretrovirals
- Antiviral
- Blood Glucose Regulators
- Blood Modifiers
- Cardiovascular Agents
- Dermatological Agents
- Gastrointestinal Agents
- Central Nervous System Agents
- Hormonal Agents
- Immunological Agents
- Ophthalmic Agents
- Phytopharmaceuticals
- Respiratory Agents
- Vaccines
- Inflammatory Bowel Diseases
Phase I Clinical Trials
At Lambda, we understand that every drug is unique. 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.
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
Cardiac Safety studies
Inhalation studies
Dermatology studies
Human Factor studies
Self-administration Studies
Biosimilars
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 Turnaround Time
- Global scientific overview
- Flexible Operational approach
Biosimilar PK/PD & Immunogenicity Studies
Lambda excels in providing comprehensive services vital for successful clinical studies supporting biosimilar marketing applications. Developing biological products is a rigorous process due to their complex protein-based molecular structure, with molecular weights ranging from 3,000 to 150,000 Daltons. This category includes Growth Hormones, Insulin, Monoclonal Antibodies (MABs), and more. Unlike chemically derived products, biosimilars require specialized assessments of Pharmacodynamic and Immunogenicity, in addition to Pharmacokinetic evaluations. Our specialized expertise is essential for the successful clinical development of these products.
Our expertise ranges from PK bioequivalence to evaluating the similarity of effects in patients. Years of analyzing drug bioequivalence and bioavailability have honed our capabilities to craft precise comparative studies, establishing biosimilarity with marketed reference drugs.
We have an impressive track record of conducting numerous studies on various biological products, including but not limited to:
BA/BE
With a foundation of strong scientific expertise, our Bioavailability/Bioequivalence units provide a robust platform for handling challenging studies. As a Global CRO, we offer 700+ clinical beds, including 85+ specialized beds dedicated to complex Bioequivalence (BE) studies. These units are staffed by highly trained and experienced study teams, conducting numerous studies annually. Our services encompass a wide range, including clinical conduct, monitoring, bioanalysis, and project management, aligning seamlessly with regulatory requirements. Our approach emphasizes robust recruitment and customized housing options, tailored to meet sponsor and study requirements.
- Dedicated "State-of-the-art" ICUs
- Pioneering implementation of IRIS registration
- Availability of qualified doctors round the clock
- Well-defined Standard Operating Procedures (SOPs)
- Adherence to stringent subject compliance measures
- Broad experience encompassing over 8,000 studies.
- Extensive database of 50,000+ healthy volunteers, including specialty populations like elderly males, non-smoker males/females, surgically sterile/post-menopausal females.
- Exclusive implementation of a complete and accurate paperless data entry system (BizNET Software), ensuring ‘On Time-Real time’ data capture from screening to the conclusion of the study.
Comprehensive Dosage Form Capabilities
All oral dosage forms
Injectable
Inhalations
Topical Products
Nasal Sprays
Suppositories
Transdermal
Vaginal Products
Ointments & Creams
Intravaginal
Nutraceuticals & Consumer Products Studies
In the rapidly evolving landscape of natural products and dietary supplements, clinical trials play a crucial role in ensuring safety and efficacy. As a leading CRO, Lambda’s expert team partners with you throughout your clinical trial journey, helping you succeed in the Nutraceuticals & Consumer Products market, expand your reach, and differentiate your products. Our dedicated team is focused on understanding your unique needs and delivering solutions that align with regulatory standards.
Lambda has a proven track record of guiding key industry players in optimizing study designs, including dosage considerations. We specialize in understanding the interactions between study drugs, nutraceuticals, and individuals with specific health conditions.
Our tailored solutions offer a comprehensive range of services, from crafting study plans and executing studies to report publication and product registration. We excel in conducting safety and efficacy studies, substantiating advertising claims, increasing public awareness, and facilitating product registration across a wide range of products.
- De-Addiction Products
- Hair Re-growth Products
- Personal Hygiene Products
- Over The Counter (OTC) Products
- Multivitamins and Nutritional supplements
- Fortified Food Products - Edible Oil, Flours, Fruit Extracts, Milk Products, Rice Extracts
Let's Unveil New Therapies Together
Connect with our experts to leverage our proven track record of clinical research excellence.