• AXIS Clinicals successfully completes 25th US FDA audit (November 2018)
  • AXIS Clinicals successfully completes 4th MHRA audit (June 2018)
  • AXIS Clinicals successfully completes 2nd WHO audit (December 2017)
  • AXIS Clinicals successfully completes AEMPS Spain (December 2018)
  • AXIS Clinicals successfully completes INFARMED Portugal (June 2018)
  • AXIS Clinicals successfully completes NPRA Malaysia (June 2018)
  • AXIS Clinicals successfully completes GCC audit (February 2016)
  • AXIS Clinicals successfully completes MCC South Africa audit (March 2017)
  • BA-BE studies conducted at AXIS Clinicals are accepted by Chile – ISP

Clinical Central Lab

Axis Clinicals has a fully equipped in-house central clinical chemistry laboratory, which supports analysis for in-house and multi-center clinical studies. Apart from having a central standard procedure, the presence of an in-house fully equipped clinical laboratory is ideal for investigating blood coagulation parameters or undertaking intensive blood processing protocols. All our integrated and stand alone services are delivered with maximum degree of control to minimize variability and enhance data quality.  

The laboratory is NABL (National Accreditation Board for Testing and Calibration Laboratories), ISO 9001:2008 and Brazil-ANVISA accredited.

Standard assays include:

  • Project Specific Clinical Data Management Plan
  • Standard Hematology and Clinical Chemistry, Serology, Urinalysis
  • Special proteins and hormone analysis
  • Drugs of abuse
  • Urinalysis (microscopy and dipstick)
  • Virology (HIV, HBV, HCV by PCR)
  • Immunology/ Serology
  • Cytology (cervical PAP smear)

Specialty assays include:

  • Platelet aggregation (routinely with up to seven agonists)
  • Coagulation factors (routine and special)
  • Electrophoresis
  • Whole blood/PBMC stimulation assays

Central Laboratory:

  • Provides all necessary materials (sample collection kits, sample storage materials, sample shipping materials and manuals/ instructions)
  • Act as logistics coordinator for both incoming and outgoing shipments
  • Receive samples, reconcile sample data with the protocol requirements and forward the samples to the laboratory for analysis. All queries are communicated with sites and CRAs to prevent delays in result reporting
  • Generate customized result reports accessible online
  • Archive laboratory data

Fact sheet

  • 2,600+ clinical studies completed since inception
  • 350+ bioanalytical methods developed
  • 50+ successful Regulatory audits
  • Global footprint of operations with sites in India, U.S & Mexico.
  • Two clinical facilities (Hyderabad & Ahmedabad) in India
  • 100+ National and International Pharma/Biotech Sponsor companies working with AXIS
  • US FDA : 500+ approvals, EMEA : 100+ approvals, Canada : 50+ approvals, Australia : 50+ approvals
  • 500+ experienced employees working globally
  • Huge database of patient population in various therapeutic areas viz. Cardiology, Opthalmology, Schizophrenia, Diabetology, Oncology. Orthopedics etc..

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