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IRT

Randomization and supply management for clinical trials with flexible protocol adaptation and real-time visibility.

Solution by YPrime
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Overview

YPrime's Interactive Response Technology (IRT) is a purpose-built clinical trial platform designed to help sponsors and CROs manage randomization and trial supply with speed, accuracy, and regulatory confidence. Built for global, complex protocols, YPrime IRT addresses the most persistent challenges in clinical research — including trial delays, protocol amendments, and supply complexity — by combining operational flexibility with expert governance and inspection-ready execution.

Recognizing that 62% of clinical trial teams cite their IRT platform as a source of delay, and that 65% report protocol amendments take approximately six weeks to implement, YPrime IRT is engineered to reduce these friction points while maintaining the data quality standards that 88% of teams identify as the top attribute when selecting an IRT platform.

Flexible IRT with Expert Governance

  • Sponsors and sites can manage routine operational updates independently to keep trials moving without unnecessary delays
  • YPrime experts implement, validate, and document higher-impact IRT changes to ensure alignment with protocol requirements and regulatory standards
  • Built-in oversight and auditability support inspection-ready execution across the full study lifecycle
  • The platform balances adaptability with control, ensuring that changes to protocol logic, supply strategy, or system behavior are handled with appropriate rigor

Industry-Leading Quality and Data Monitoring

  • Transparent access to clinical trial data throughout the study lifecycle enables proactive oversight rather than reactive remediation
  • Preventive actions can be enabled and issues addressed in real time
  • Enrollment, drug distribution, and study progress can be monitored with confidence
  • End-to-end issue resolution benchmarks are achieved within a month, reflecting top-tier quality standards
  • Trend analysis tools help identify potential risks and optimize decision-making
  • Normalized and readily available clinical trial data supports in-depth monitoring and analysis
  • Seamless connectivity with EDC, CTMS, and other clinical systems supports unified trial oversight

Performance and Execution at Scale

  • IRT startup times are achieved 50% faster compared to industry norms
  • A 97.6% ticket SLA achievement rate demonstrates consistent operational reliability
  • An in-house help desk with a 26-second speed-to-answer ensures rapid site and sponsor support
  • The platform is designed to support complex, global trials while maintaining control, compliance, and data integrity

Adaptive Oncology Trial Case Study

  • A top pharmaceutical sponsor selected YPrime IRT for an adaptive, early-phase oncology trial with complex stratification and supply requirements
  • YPrime delivered flexible clinical supply management, sponsor-controlled cohort management, and easy adjustment of dispensing levels
  • Seamless integration with EDC and CTMS systems was achieved
  • Measured outcomes included a four-week study startup, strong quality assurance across integrated systems, seamless participant transition between study phases, and 100% successful data exchange with existing clinical trial technology platforms

Key Capabilities Summary

  • Randomization and trial supply management (RTSM) for complex, multi-phase protocols
  • Protocol amendment support with rapid implementation and full documentation
  • Drug transit visibility and dispensing level management
  • Real-time enrollment and supply monitoring dashboards
  • Integration with EDC, CTMS, and other clinical data platforms
  • Audit-ready reporting and governance controls throughout the study lifecycle

YPrime IRT is available to sponsors and CROs seeking a clinical trial technology partner that reduces site burden, improves execution quality, and protects data integrity without sacrificing compliance. The platform is backed by deep clinical trial expertise and is designed to scale across global, complex study designs.

Meta

Domain
Clinical Trial Management
Subdomain
Randomization & Trial Supply Management
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP