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Zero compromise delivery of Cross-Continental Biosimilar Study

DiagnoSearch enabled smooth execution of a complex biosimilar program across Phase I (Australia) and Phase III (India), delivering high-quality outcomes through tailored IWRS, fast eligibility verifications, and complete clinical oversight—culminating in expedited product approval.

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Situation & Challenge

A global sponsor initiated clinical development of a biosimilar Trastuzumab across two distinct phases:

  • Phase I in Australia
  • Phase III in India

The program spanned 34 sites and 236 subjects, requiring seamless integration of operations across regions, along with:

  • Rapid subject eligibility verification
  • Complex IWRS setup for stratified dosing
  • High-quality data and documentation aligned with regulatory timelines
  • Full-spectrum services across monitoring, data management, and project oversight

Our Solution

DiagnoSearch deployed an integrated, multi-regional team to deliver

Comprehensive project management, monitoring, data management, and regulatory coordination
A custom-built IWRS system tailored to dosing and stratification needs
Eligibility verifications completed within 2 business days, minimizing site delays
On-schedule execution of recruitment, site monitoring, and data cleaning
Real-time collaboration and centralized oversight to keep milestones on track

Results and Impact

  • All study milestones met—including recruitment, site activations, and final data submissions
  • Regulatory approval achieved within a shortened timeframe
  • Seamless coordination across two regions and phases demonstrated DiagnoSearch’s ability to:
    • Execute complex, multi-phase studies with precision
    • Adapt technology to protocol-specific needs
    • Align trial operations with regulatory strategy
    • Deliver results through speed, flexibility, and scientific rigor

Multi-Phase Trastuzumab Trial Across Australia & India

236

Subjects

34

Sites

Early &
Late Phase

Accelerated
Approval

DiagnoSearch supported a biosimilar Trastuzumab program from Phase I in Australia to Phase III in India, delivering clinical and operational excellence across continents. With adaptive IWRS, real-time verification, and full-spectrum services, the study met all milestones and achieved swift regulatory clearance.

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