An IRT live in under 4 weeks for an 8,000-subject COVID-19 vaccine trial
YPrime built and launched a full-featured IRT for a Phase 2/3 randomized, blinded, placebo-controlled vaccine study, from contract signing to go-live in less than 4 weeks.
AT A GLANCE
YPrime deployed a full-featured interactive response technology (IRT) system for a Phase 2/3 COVID-19 vaccine trial in under 4 weeks, measured from contract signing to go-live. The study was randomized, blinded, and placebo-controlled, with more than 8,000 subjects across nearly 50 sites and a two-visit design.
A leading pharmaceutical sponsor came to YPrime during the height of the COVID-19 pandemic with a Phase 2/3 vaccine study that had to start fast. More than 8,000 subjects. Nearly 50 sites. A public health timeline that wasn’t going to move.
The IRT had a lot to carry. It needed to randomize and blind subjects across 2 vaccination visits, account for every kit at every site, connect to the sponsor’s existing clinical system, and meet regulatory and data integrity requirements from the first randomization. A shortened build couldn’t mean a thinner system. The sponsor needed full functionality on a timeline most IRT projects don’t get.
YPrime delivered a complete IRT in less than 4 weeks from contract signing to go-live. The team’s experience with vaccine trial requirements kept the build moving, and YPrime’s configurable IRT platform handled the study design.
The system covered randomization and blinding for the two-visit design, treatment arm and placebo assignment, drug supply and accountability, site inventory tracking, automated shipment triggers, and real-time reporting on study metrics.
Study overview
Go live in under 4 weeks: The full IRT went from signed contract to live system in less than 4 weeks, with regulatory compliance maintained through launch.
Randomize and blind across 2 visits: Treatment arm assignment and placebo controls ran inside the IRT for both vaccination visits.
Account for every kit at every site: Drug supply management and accountability covered nearly 50 sites, with site-level inventory tracked in the system.
Resupply sites automatically: Automated shipment triggers handled site resupply, so the study team spent less time chasing orders.
Connect to existing clinical systems: The IRT was set up to work with the sponsor’s clinical systems already in place.
Watch the study in real time: Live reporting and study metrics gave the team a current view of randomization and supply across every site.
Frequently Asked Questions
For this Phase 2/3 COVID-19 vaccine trial, YPrime went from contract signing to go-live in less than 4 weeks, supporting more than 8,000 subjects at nearly 50 sites. YPrime has also deployed IRT for an early-phase oncology trial with complex stratifications in under 4 weeks.
Randomization and blinding across a two-visit design, treatment arm and placebo assignment, drug supply and accountability, site inventory, automated shipment triggers, and real-time reporting.
IRT assigns each subject to a treatment arm while keeping the blind, and it tracks investigational product from depot to site. With 8,000+ subjects and a placebo arm, both jobs have to be right at every visit.