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India’s Landmark Rotavirus Phase III Trial

DiagnoSearch led the successful execution of a 7,500-infant Phase III vaccine trial in India, using custom-built offline IWRS technology to overcome low-connectivity barriers while ensuring full compliance from start to finish.

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Situation & Challenge

A pivotal Phase III trial for a rotavirus vaccine requiring enrolment of 7,500 paediatric participants (aged 6–8 weeks) across 6 sites in India. The study faced key challenges:

  • Remote or low-connectivity satellite sites
  • High-volume SAE management and reporting
  • Intensive protocol training
  • Technological customization for seamless dose management

Our Solution

DiagnoSearch provided end-to-end clinical support across all critical areas:

Site Enablement & Training
  • Customized site operational plans
  • Face-to-face and virtual training modules
  • Train-the-Trainer workshops with evaluations
Project Management & Monitoring
  • Risk-based monitoring framework
  • Over 2,100 site monitoring man-days
Core Services
  • Data Management and Biostatistics
  • SAE Management with 100% compliance
  • IWRS design and implementation
  • Lab and site supply management
  • Analytical lab oversight

Offline IWRS Innovation

To address unreliable internet access, DiagnoSearch developed a custom offline IWRS module, enabling uninterrupted randomization and dose dispensation even at remote sites.

Results and Impact

DiagnoSearch’s scientific agility and field-driven innovation ensured smooth execution of this high-volume pediatric trial.

Key outcomes included

  • 7,500 infants enrolled across 6 sites within ~10 months
  • ~375,000 eCRF pages processed with clean, audit-ready data
  • Over 3,300 SAEs managed with 100% compliance
  • 22,500 IWRS doses dispensed, powered by the offline module
  • 2,100+ monitoring man-days delivered through a risk-based model

DiagnoSearch’s blend of scientific rigor and field-driven innovation ensured smooth execution of a large-scale pediatric trial. The study played a critical role in advancing rotavirus vaccine development for infant populations in India and beyond.

Rotavirus Vaccine Trial with Offline IWRS Innovation

6 Sites

in India

Phase
III

7500

Infants

~10

Months

DiagnoSearch delivered full-spectrum support for a high-stakes rotavirus vaccine trial in India. Leveraging operational rigor and offline IWRS technology, the study achieved rapid enrollment, robust safety reporting, and high-quality data across low-connectivity sites.

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