In the fast-paced and highly regulated world of clinical research, pharma and biotech leaders often have numerous questions regarding the processes, technologies, and compliance standards involved. At Lambda Therapeutic Research, we understand the importance of providing clear and comprehensive answers to these queries. This blog addresses the top Clinical Research FAQs we receive from industry leaders, highlighting our expertise and commitment to excellence in clinical research. By addressing these common concerns, we aim to demonstrate our capabilities and reassure potential clients of our ability to meet their clinical research project needs.

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What clinical trial phases does Lambda Therapeutic Research support?

Lambda Therapeutic Research offers comprehensive support across all phases of clinical trials, from early-phase to late-phase studies.

• Early Phase – Phase I (First-in-Human Studies): Our expertise includes first-in-man studies, bioavailability and bioequivalence studies, and complex PK/PD studies, ensuring safety and optimal dosing for new compounds.
• Phase II-III (Efficacy and Safety Trials): We manage trials that focus on therapeutic efficacy in larger patient populations, working across various therapeutic areas such as oncology, dermatology, immunology, psychiatry and CNS disorders.
• Phase IV (Post-marketing Studies): Lambda conducts observational studies, and pharmacovigilance programs to monitor the long-term safety and effectiveness of products post-approval.

What therapeutic areas do you specialize in?

Lambda has extensive experience across a broad range of therapeutic areas, enabling us to cater to the diverse needs of biotech and pharmaceutical companies:

• Oncology & Hematology
• Dermatology
• Neuroscience
• Biosimilar Development
• Infectious Disease
• Pulmonology
• Cardiovascular & Metabolic disorder
• Gastroenterology
• Nephrology
• Ophthalmology
• Musculoskeletal
• Cross-Therapeutic

What expertise does Lambda offer in biosimilar development?

In a world where access to life-saving biologics is often limited, the demand for cost-effective biosimilar solutions is more critical than ever. At Lambda Therapeutic Research, we understand the complexities involved in bringing these vital products to market. Our proven track record in biosimilar development positions us as a trusted partner for pharmaceutical and biotech companies.

Our expertise encompasses the design of effective development plans and regulatory strategies tailored specifically for biosimilars, ensuring successful program execution. We adeptly navigate global market requirements and operational challenges, expediting biosimilar development and increasing accessibility. We offer comprehensive clinical and bioanalytical services that are integral to the biosimilar development process.

Our biosimilar research spans therapeutic areas such as oncology, ophthalmology, immunology, and endocrinology.

How Lambda support global clinical trials?

Yes, Lambda conducts global clinical trials with facilities across North America, Europe, and Asia. Our strategic locations, combined with an extensive network of clinical sites, enable us to manage trials efficiently across diverse geographies. We are well-versed in global regulatory requirements, ensuring smooth trial operations and faster approvals.

Why should pharma and biotech companies choose Lambda?

We are dedicated to helping you bring innovative therapies to market faster and more efficiently.

How does Lambda overcome challenges in patient recruitment and retention for clinical trials?

Recruitment and retention of patients pose significant challenges in clinical trials, often leading to delays. At Lambda Therapeutic Research, we excel in navigating these challenges by utilizing our extensive global network of clinical sites across North America, Europe, and Asia. This enables us to access a diverse and representative patient population for our studies. Our team’s experience in fostering strong relationships with local healthcare providers enhances our ability to connect with potential participants effectively. We also prioritize patient engagement, ensuring a supportive experience throughout the trial process. Additionally, our unique strategies significantly improve patient retention rates.

Is biomarker testing common in clinical trials?

Yes, biomarker testing is increasingly common in clinical trials due to its vital role in improving study outcomes and advancing precision medicine.

Why is biomarker testing important in clinical trials?

Biomarkers are measurable indicators of biological processes, diseases, or treatment effects. Their inclusion in clinical trials offers several benefits, such as:

• Companion Diagnostics: Supporting the use of diagnostic tools to determine patient eligibility for targeted therapies.
• Patient Stratification: Identifying subpopulations more likely to respond to treatment.
• Efficacy Assessment: Acting as surrogate endpoints for early evaluation of a therapy’s effectiveness.
• Safety Monitoring: Predicting or tracking adverse events during the trial.
• Mechanism Validation: Confirming the drug’s mechanism of action.

Where are biomarkers commonly used?

• Oncology: Genetic testing (e.g., EGFR, BRCA) to guide targeted therapies.
• Cardiology: Biomarkers like troponin for assessing cardiovascular risks.
• Immunology: Cytokine level monitoring to evaluate immune responses.

The widespread use of biomarkers enhances trial efficiency, patient safety, and regulatory approvals, making them an integral part of modern clinical research.

What are 3rd party vendors in clinical trials?

A clinical research vendor is a third-party organization that provides specialized services to support the efficient conduct of clinical trials. These vendors offer a wide range of services, including trial design and management, patient recruitment and retention, data collection and analysis, home care support, and other essential functions. They play a critical role in the clinical research ecosystem by bringing expertise, resources, and technologies that may not be readily available within the sponsor’s or investigator’s organization. By streamlining trial operations, ensuring compliance with regulatory standards, and enhancing the quality and integrity of collected data, clinical research vendors contribute significantly to the successful execution of clinical trials.

What is a randomized clinical trial (RCT)?

A randomized clinical trial (RCT) is a type of clinical study in which participants are randomly assigned to different groups to compare the effects of a specific intervention. This gold-standard approach helps ensure that the results are unbiased and reliable. In an RCT, one group receives the experimental treatment (e.g., a new drug, therapy, or medical device), while the other group, often called the control group, may receive a placebo, standard treatment, or no intervention.

About Lambda: Lambda Therapeutic Research is a leading full-service Global Clinical Research Organization (CRO) headquartered in Ahmedabad (India), with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Barcelona (Spain), Toronto (Canada), Las Vegas (USA) and Pittsburgh (USA). Lambda provides comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. With a commitment to excellence, our experienced team of 1200+ professionals utilizes cutting-edge technology and innovative solutions to provide a full spectrum of clinical trial solutions spanning from preclinical research to post-marketing studies. Over two decades of dedication to excellence has earned us numerous accolades, including the distinction of ‘Best Indian CRO’ by Frost & Sullivan (USA) and the coveted title of ‘Great Indian Workplace’ by UBS Transformance. Lambda Therapeutic Research has been recently honored with the ‘Regulatory Excellence’ Award at the CPHI Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.