Jump to content

User:Dipeshgc/sandbox

From Wikipedia, the free encyclopedia
Lambda House (Ahmedabad)
Lambda Therapeutic Research Limited
IndustryClinical Research
Headquarters
Ahmedabad
,
India
Number of employees
1000
Websitewww.lambda-cro.com

Lambda Therapeutic Research is a full-service global clinical research organization (CRO) established in 1998. The company provides a comprehensive range of clinical trial solutions to the pharmaceutical, biotechnology, and generic drug industries. With a global presence, Lambda operates facilities in India, North America, and Europe, under the unified brand name of Novum Pharmaceutical Research Services in North America.

The company is recognized for conducting clinical research spanning from early-stage development to post-marketing studies. Lambda Therapeutic Research operates in a variety of therapeutic areas, with a particular focus on biosimilars, oncology, rare diseases, and early-phase studies.

History

[edit]

Lambda Therapeutic Research was founded in 1998 in Ahmedabad, India, with the goal of offering high-quality clinical trial services to the pharmaceutical industry. Over the years, Lambda expanded its operations internationally, setting up facilities in countries including the United States, Canada, the United Kingdom, and Poland. Through its acquisition of Novum Pharmaceutical Research Services in 2017, Lambda solidified its presence in the North American market, enhancing its capabilities in early-phase trials, clinical development, and bioanalytical services.

Services

[edit]

Lambda Therapeutic Research offers a wide array of services that support clinical trials across multiple phases of drug development:

  • Early Phase / Phase I Clinical Trials: Specializing in first-in-human (FIH) studies, pharmacokinetic (PK), pharmacodynamic (PD), and biosimilar studies.
  • Late Phase / Phase II-IV Trials: Conducting larger trials for efficacy, safety, and post-marketing surveillance.
  • Bioanalytical Services: Offering state-of-the-art laboratory services including bioanalysis for large and small molecules, immunogenicity testing, and pharmacokinetics.
  • Medical Imaging: Providing centralized imaging services that comply with regulatory requirements and support clinical trials in oncology and other therapeutic areas.
  • Pharmacovigilance: Comprehensive drug safety monitoring and regulatory reporting across global markets.
  • Regulatory Affairs: Supporting clients in meeting regulatory requirements for drug approval processes, including submissions to the USFDA, EMA, and other regulatory bodies.

Collaborations and Partnerships

[edit]

Lambda partners with pharmaceutical and biotechnology companies to deliver clinical trial solutions across all phases of development. The company's collaborations focus on accelerating the timelines for drug development and ensuring compliance with international regulatory standards. Through its partnerships, Lambda provides support for both large multinational companies and emerging biotech firms, particularly in the areas of biosimilars, oncology, and rare diseases.