Faster IRT Startup for a 10-year Global Study Across 45 Countries
A large global sponsor brought in YPrime after previous IRT vendors fell short. YPrime started the IRT 4x faster and implemented protocol amendments 8x faster, across 45 countries and 34 cohorts.
AT A GLANCE
YPrime delivered interactive response technology (IRT) for a large sponsor’s 10-year global clinical trial spanning 45 countries, with multiple treatment arms across 34 cohorts and a separate portal for each lab. YPrime’s IRT delivered 4x faster startup and 8x faster protocol amendment implementation. YPrime’s in-house help desk answered 100% of calls in under 30 seconds and connected callers to native-language support in under 1 minute.
The Technology Challenge
A large global sponsor needed an IRT partner for a 10-year study, plus the future protocols that would join the same system. Its previous IRT vendors had fallen short on timelines, study complexity, integrations, and country and material sourcing requirements.
The scope was big. 45 countries. Multiple arms across 34 cohorts. A separate portal for every lab, with room for future patient and sponsor partners who’d need portals of their own.
The sponsor wanted a long-term partner and a design built to take on new protocols without IRT system amendments. And with sites in 45 countries, support had to work in each site’s language, held to the same service levels as a smaller study.
The YPrime IRT Solution
YPrime configured its IRT platform around the sponsor’s workflow, system integrations, vendor management, protocol specifications, amendments, material sourcing, and country requirements. Pre-validated configurations shortened the build and reduced risk before go-live.
The study team got real-time KPIs and reports on drug transit, site performance and compliance, and product excursions. YPrime’s 24/7/365 in-house help desk, staffed by study-trained experts, supported sites in all 45 countries.
IRT case study
Study overview
4x
Faster IRT startup
8x
Faster protocol amendment implementation
45
Countries
34
Cohorts with multiple treatment arms
10 years
Global study duration
How YPrime IRT Supported a 10-year Global Study
- Start up 4x faster: Pre-validated configurations helped deliver 4x faster startup for a 45-country study.
- Implement amendments 8x faster: Protocol amendments went into the live system 8x faster, so study changes didn’t stall enrollment.
- Give every lab its own portal: Each lab across 45 countries had a dedicated portal, with room to add patient and sponsor partner portals later.
- Bring future protocols into one system: The IRT was designed so new protocols could join the existing system over the life of the program.
- Connect to other systems: 99.8% seamless integrations across the study’s connected systems.
- Track supply in real time: Cap management by country and site, participant status, and container orders and tracking.
- Keep a full audit trail: Audit logs at the patient, site user, and container level.
- Answer every call fast, in the site’s language: 100% of calls answered in under 30 seconds, with native-language support in under 1 minute.
- Ship to IATA standards: IATA (International Air Transport Association) logistics certification backed global drug shipments.
Frequently Asked Questions on IRT
For a 10-year global study across 45 countries and 34 cohorts, YPrime delivered 4x faster IRT startup. YPrime has also deployed IRT for an 8,000+ subject Phase 2/3 vaccine trial in under 4 weeks.
In this 45-country study, YPrime implemented protocol amendments 8x faster. Pre-validated configurations let the team make changes without rebuilding the system.
Yes. YPrime designed this sponsor’s IRT so future protocols could be added to the same system, along with new patient and sponsor partner portals as the program grew.
YPrime runs a 24/7/365 in-house help desk staffed by study-trained experts. In this 45-country study, 100% of calls were answered in under 30 seconds, and callers reached native-language support in under 1 minute.
YPrime recommends evaluating 3 fundamentals: service (is the team invested in your study?), execution (can they deliver to protocol consistently?), and accountability (how do they respond when problems come up?).
Interactive response technology (IRT) is software that sponsors and CROs use to manage participant enrollment and randomization, drug dispensation, and inventory. It directly affects trial timelines and data integrity.