Advancing Clinical Development in Women’s Health

Advancing Clinical Development in Women’s Health - Lambda-Novum CRO

At Lambda and Novum, we understand the need for clinical research that addresses the unique medical needs of women across different life stages. From reproductive health to postmenopausal care, our experience in conducting clinical trials is helping advance therapies that improve health outcomes and quality of life for women.

A Comprehensive Approach to Women’s Health

Clinical development for Women’s health requires a deep understanding of gender-specific physiology, disease progression, and therapeutic response. With a growing portfolio in women’s health, Lambda and Novum remain focused on developing therapies across a wide range of gynaecological health conditions. We understand that clinical trials can be complex for female participants, which is why we emphasize a patient-centric approach throughout the study lifecycle. At Lambda & Novum, we’ve built meaningful expertise across gynaecological and reproductive health conditions through our work on 15+ clinical trials to date. Our experience spans indications such as:

  • Vulvovaginal Atrophy (VVA)
  • Vulvovaginal Candidiasis
  • Birth Control / Contraceptive Products
  • Assisted Reproductive Technology (ART)
  • Urethral Stricture
  • Hormone Replacement Therapy (HRT)
  • Postmenopausal Women with Osteoporosis

Delivering End-to-End Excellence

Lambda & Novum’s comprehensive clinical research services—spanning study design, regulatory strategy, patient recruitment, site management, and data delivery—help our clients effectively navigate the complexities of women’s health trials. Our cross-functional teams—including clinical operations, medical affairs, regulatory, and data management—collaborate closely with pharmaceutical and biotech organizations to ensure studies are executed with scientific rigor, operational efficiency, and regulatory alignment. With a global site network, we support timely patient recruitment and access to diverse populations—key to achieving meaningful outcomes and regulatory success.

Our end-to-end capabilities—including medical imaging, biostatistics, bioanalytical & pharmacovigilance services—allow us to provide comprehensive solutions for our clients. By maintaining the highest standards of quality and regulatory compliance, we ensure reliable, high-quality trial outcomes. Our successful regulatory track record highlight our deep understanding of global regulatory frameworks and our expertise in navigating the complexities of the approval process.


About us

Lambda & Novum delivers comprehensive, end-to-end clinical research services to the innovator, biotech, and generic pharmaceutical industries worldwide. With a strong global presence in India, the USA, Canada, the UK, Spain and Poland, we bring specialized expertise to every project. Our focus on secure IT infrastructure and automation ensures timely project delivery and strict adherence to international regulatory standards. Lambda’s exemplary regulatory track record includes over 60 successful inspections and audits by esteemed authorities, including the USFDA, EMEA, MHRA, EU member states, and other global regulatory bodies, in the past five years.

Lambda’s commitment to excellence has garnered significant recognition, including the ‘Best Indian CRO’ award from Frost & Sullivan (USA) and the ‘Great Indian Workplace’ title from UBS Transformance. Recent accolades include the ‘Regulatory Excellence’ Award at the CPhI Pharma Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.

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