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CLINICAL RESEARCH

AXIS

Specialty insurance and reinsurance for complex risks

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AXIS

Clinical ResearchHyderabad, India

Specialty insurance and reinsurance for complex risks

About AXIS

Founded in 2004 and headquartered in Hyderabad, Telangana, Axis Clinicals Limited has grown into an internationally recognised contract research organisation operating across India, the United States, and Mexico. With a workforce of more than 500 professionals, the company serves pharmaceutical, biotechnology, and generic drug sponsors seeking a single partner for early- and late-phase development.

The company's core strength lies in bioavailability and bioequivalence (BA/BE) studies, which account for approximately half of annual revenue and are conducted from dedicated facilities in Hyderabad and Ahmedabad. Alongside BA/BE work, Axis Clinicals delivers pharmacokinetic and pharmacodynamic (PK/PD) patient studies, Phase I through Phase IV clinical trials, bio-analytical laboratory services, and a clinical central laboratory. Supporting disciplines include project management, PK biostatistics and programming, medical writing, regulatory affairs, clinical data management, and quality assurance and compliance.

Facilities carry DCGI and NABL accreditation under ISO 15189 and have been inspected and approved by the US FDA, UK MHRA, Brazil ANVISA, and France ANSM, confirming adherence to ICH GCP and GLP guidelines across international markets. A parallel US entity, Axis Clinicals USA, serves North American sponsors seeking early-phase trial unit capabilities.

Further information is available at axisclinicals.com.

Areas of Expertise

Clinical Data ManagementClinical ResearchRegulatory Affairs

Services & Capabilities

Clinical Data ManagementClinical ResearchRegulatory Affairs
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