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Therapeutic Areas
Proven Expertise Across Therapeutic Areas
From early development to regulatory approval across multiple therapeutic areas, Q2BI delivers comprehensive end-to-end biometrics support that accelerates drug development. With 1800+ studies and 50+ NDA/BLA approvals, we help bring life-changing therapies to patients faster.
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Studies Delivered
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NDA/BLA Approvals
Oncology
Deep expertise across solid tumors, hematological malignancies, and immuno-oncology. Our teams have supported Phase I-III trials for checkpoint inhibitors, ADCs, CAR-T therapies, and targeted small molecules. Experience spans lung, breast, colorectal, prostate cancers, lymphomas, and leukemias with complex endpoint analyses including RECIST 1.1 and PCWG3.
CNS & Neurology
Comprehensive experience in Alzheimer's disease, Parkinson's disease, multiple sclerosis, epilepsy, and psychiatric disorders. Our biostatisticians understand the complexities of CNS endpoints including cognitive assessments (ADAS-Cog, MMSE), rating scales, and long-term safety monitoring required for regulatory success in this challenging therapeutic area.
Cardiovascular & Metabolic
Proven track record in heart failure, atherosclerosis, hypertension, and diabetes trials. Expertise in MACE endpoint adjudication, cardiovascular outcome trials (CVOTs), and complex safety analyses. Our teams have supported multiple successful submissions with FDA and EMA requiring extensive integrated safety summaries.
Therapeutic Areas
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