• AXIS Clinicals successfully completes 14th US FDA audit (June 2016)
  • AXIS Clinicals successfully completes US FDA audit for ICP-OES services (March 2016)
  • AXIS Clinicals successfully completes 7th ANVISA – Brazil audit (March 2015)
  • AXIS Clinicals successfully completes WHO audit (March 2015)
  • AXIS Clinicals successfully completes 3rd MHRA audit (Sep 2014)
  • BA-BE studies conducted at AXIS Clinicals are accepted by Chile – ISP

Phase II- IV

Our integrated capabilities can help you minimize risk, ensure trial feasibility and drive regulatory and commercial success of your program. Our team of clinical research professionals are efficient in designing the protocol, conducting the study, generation of the clinical study report and the regulatory submissions. Our well-trained and highly qualified Project Managers, Senior Clinical Research Associates, Clinical Research Associates and Clinical Trial Assistants having years of clinical monitoring experience  across various therapeutic areas are working with more than 200 clinical investigators across 110 research sites to execute the projects.

AXIS Clinicals offers a full range of clinical research services for the pharmaceutical, medical device, biopharmaceutical and CRO industries including:

  • Study Development
  • Site Qualification visit
  • Site Initiation visit
  • Interim monitoring visit
  • Site Close out visit
  • Intellectual Advisory Board
  • Translational Science Specialists
  • Protocol Development
  • CRF Design & Distribution
  • Patient Recruitment

Additionally, we have the proven track record to conduct New Drug Application (NDA) and Biologics License Application (BLA) clinical studies across range of therapeutic areas for vast study types with diverse healthy volunteers and patient population.

 

Fact sheet

  • Over 1,600 clinical studies completed since inception
  • Over 290 bioanalytical methods developed
  • Over 38 successful Regulatory audits
  • Global footprint of operations with sites in India, U.S, Mexico & Thailand.
  • Two clinical facilities in India
  • 60+ National and International Pharma/Biotech Sponsor companies working with AXIS
  • US FDA : 200+ approvals, EMEA : 70+ approvals, Canada : 20+ approvals, Australia : 30+ approvals
  • 350+ staff working globally
  • Huge database of patient population in various therapeutic areas viz. Cardiology, Opthalmology, Schizophrenia, Diabetology, Oncology. Orthopedics etc..

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