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Clinical Trial

At

galaxbiotech.com

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India

Bengalore

Mexico

Monterrey

USA

5473 Blair Rd Ste 100 PMB 861103 Dallas, Texas 75231-4227 US

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This is what
we do best

Our services

Clinical Data
Management & EDC

Capture clean, compliant clinical data with configurable eCRFs and edit checks.

  • Protocol Review & eCRF Design
  • Edit Checks, Validations & SDV Strategy
  • Central Data Cleaning & Query Management
  • CDISC Standards & Mapping (SDTM/ADaM)
  • Medical Coding & Safety Reconciliation
  • Database Lock & Submission Readiness
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Biostatistics, CDISC &
TLF Programming

Plan, randomize and track your studies end-to-end in a single platform.

  • Study Design & Sample Size Estimation
  • Statistical Analysis Plan & Mock Shells
  • CDISC SDTM & ADaM Conversion
  • TLF Programming & Automation
  • PK/PD, Biomarker & Special Analyses
  • CSR, ISS/ISE & Regulatory Support
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Pharmacovigilance &
Safety Analytics

Centralized case management, signal detection and safety reporting.

  • Global Safety Strategy & Governance
  • Case Intake, Triage & ICSR Management
  • Medical Review, Coding & Signal Detection
  • Aggregate Reporting: PSURs, DSURs & PBRERs
  • Safety Data Reconciliation & Quality Oversight
  • Safety Analytics Dashboards & Insights
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CTMS / eTMF / LUP &
Trial Operations

Risk-based quality oversight with real-time dashboards and trial performance metrics.

  • Study Startup & Site Feasibility
  • Site Activation & Contract Management
  • Visit Planning, Monitoring & Action Items
  • Enrollment, glxestones & Risk Tracking
  • eTMF Management & Inspection Readiness
  • Vendor Oversight, Portfolio & Executive Reporting
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Looking to make your mark? We'll help you turn
your project into a success story.

Let’s make an impact
together. Ready when you are

Contact us