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      • 2. FY 2021-22
      • 3. FY 2022-23
  • Home
  • About Us
    • Our DNA
    • Our Core Values
    • Your Preferred Partner of Choice โ€“ WHY?
    • Our Focus
    • Our Leadership
    • Accreditations
    • Global Locations
  • Services
    • BA | BE Studies
    • PK | PD and Patient Studies
    • Bio-Analytical Services
    • Phase I
    • Phase II-IV
    • Project Management
    • PK | Biostatistics & Programming
    • Medical Writing
    • Regulatory Services
    • Quality Assurance and Compliance
    • Clinical Data Management
    • Clinical Central Lab
  • Careers
  • News & Media
  • Contact Us
  • Investors
    • Annual Report
    • Codes & Policies
      • 1. Vigil Mechanism Policy
      • 2. Corporate Social Responsibility Policy
      • 3. Criteria for Directors
      • 4. Nomination & Remuneration Policy
    • Corporate Social Responsibility
      • 1. Corporate Social Responsibility Policy
      • 2. Composition of CSR Committee
    • Annual Return
      • 1. FY 2020-21
      • 2. FY 2021-22
      • 3. FY 2022-23

PK | Biostatistics & Programming

You are here: Home / 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

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  • Home
  • About Us
    • Our DNA
    • Our Core Values
    • Your Preferred Partner of Choice โ€“ WHY?
    • Our Focus
    • Our Leadership
    • Accreditations
    • Global Locations
  • Services
    • BA | BE Studies
    • PK | PD and Patient Studies
    • Bio-Analytical Services
    • Phase I
    • Phase II-IV
    • Project Management
    • PK | Biostatistics & Programming
    • Medical Writing
    • Regulatory Services
    • Quality Assurance and Compliance
    • Clinical Data Management
    • Clinical Central Lab
  • Careers
  • News & Media
  • Contact Us
  • Investors
    • Annual Report
    • Codes & Policies
      • 1. Vigil Mechanism Policy
      • 2. Corporate Social Responsibility Policy
      • 3. Criteria for Directors
      • 4. Nomination & Remuneration Policy
    • Corporate Social Responsibility
      • 1. Corporate Social Responsibility Policy
      • 2. Composition of CSR Committee
    • Annual Return
      • 1. FY 2020-21
      • 2. FY 2021-22
      • 3. FY 2022-23

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  • About Us
  • Our DNA
  • Our Core Values
  • Your Preferred Partner of Choice
  • Our Focus
  • Our Leadership
  • Accreditations
  • Global Locations
  • Services
  • BA | BE Studies
  • PK | PD and Patient Studies
  • Bio-Analytical Services
  • Phase II-IV
  • Project Management
  • PK | Biostatistics & Programming
  • Medical Writing
  • Regulatory Services
  • Quality Assurance and Compliance
  • Clinical Data Management
  • Clinical Central Lab
  • Careers
  • News & Media
  • Contact Us

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