• 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

Clinical Data Management

Our Clinicals’ Data Management team has valuable experience working with global and domestic sponsors and renders well timed, accurate, highest standard clinical trial data, helping you to make prompt and more effective decisions with regards to the safety, tolerability and PK |PD properties of your compound.

The team has handled both paper and EDC on all standard industry platforms. Axis offers 21 CFR Part 11 compliant integrated service | stand-alone data management support on Oracle Clinical® v4.6 with RDC platform or remotely through a secure, direct-access connection to your clinical data management system.

Our services includes but not limited to:

  • Project Specific Clinical Data Management Plan
  • Customized Database Design & Development
  • Independent Double‐Data Entry
  • Design pCRF / eCRF
  • Develop CRF completion guidelines
  • Query Management
  • Medical Coding, SAE Data Reconciliation
  • Edit, Validation and Design check
  • Programming
  • Data Validation
  • Database Testing & UAT
  • Data Migration
  • Data Loading
  • Data Cleaning
  • Quality Control and Data Quality Audits
  • Database Lock and Export to SAS
  • Project Data Archival and Storage
  • Documentation CDM Report

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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