• 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

PK | Biostatistics & Programming

PK | Biostatistics Team at Axis is competent and offers accurate statistical analysis for BA | BE studies and Phase II-IV clinical trials. Our diversely experienced personnel bestow intuition into trial design, develop complex statistical analysis plans and support clients throughout the regulatory filing process.

Biometrics services at AXIS Clinicals include protocol writing, statistical analysis and report writing. Our Biometrics Division is well equipped with the latest software like Win NonLin and SAS (SDMS & MED X view).

Our Biostatistics team is capable of handling amendments in Sponsor requirements and is swift to respond, striving for complete satisfaction with the best quality or timelines. Our services include:

Database Programming

  • CRF Design (paper & electronic)
  • CRF Annotation
  • Database Programming
  • Validation Checks

 

Data Management

  • Data Acquisition
  • Data Reconciliation
  • Discrepancy Management
  • Medical Coding (MeDRA & WHODD)
  • Database Lock
  • Data Extraction for Reporting

 

Biostatistics

  • Randomization
  • Sample size estimation
  • Trial Design Inputs
  • Statistical Analysis Plan
  • Statistical Analysis
  • Biostatistics Subject Matter Expert (Tie up with global consultants)

 

Statistical Reporting

  • TLF Programming
  • CDISC Data Mapping (SDTM & ADaM)
  • Clinical Data Repository
  • Pooled Data Analysis & Reporting
  • Safety (ADR) Reporting
  • Patient Profiles & Data Cleaning Reporting
  • Feasibility analysis
  • Help in SAP & TLG|F mock shell preparation | CDISC | SDTM | ADaM standards
  • Uploading for EDC | Blinded envelops
  • Work on PK | PD Calculations
  • Evaluate statistical analysis & reporting
  • Provide preliminary results review
  • Give timely responses to regulatory query
  • Stay informed about the up-to-date statistical techniques approved by regulatory authorities such as USFDA, EMEA and DCGI


 

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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