Case Study: Two Protocols, One Portal = Efficiency and Cost Savings

IVRCC Randomization and Trial Supply Management applications for two pivotal studies

IVRCC collaborated with the client on a multi-center, randomized, double-blind, parallel group, vehicle-controlled study.

Highlights

  • The client realized a significant cost savings by combining two protocols, IRT application build, validation, hosting and maintenance costs into one application.
  • Users and data of the system for one protocol were completely invisible from the other.

Objective

To compare the efficacy and safety of the Investigation Material in Lotion to Vehicle Lotion in subjects with acne vulgaris after 12-weeks of topical treatment.

Statistics

  • Phase 3 pivotal Acne Study using topical lotion
  • Two operationally identical protocols, to be run contiguously
  • Web-based Registration, RTSM (Randomization & Trial Supply Management), CTM Management (Clinical Trial Material: Dispensation, Resupply, Tracking/Inventory)
  • 420 enrolled subjects per protocol for a total of 840 over a 12-20 week treatment period
  • Subjects enrolled had moderate to severe facial acne vulgaris
  • 1:1 randomized, double-blind, parallel group, vehicle-controlled study
  • 30 sites in the US

Challenges

This particular study required two identical protocols to be running at virtually the same time. The client initially anticipated running two completely separate applications and portals, which turned out to be cost-prohibitive.

IVRCC Solutions to Meet Challenges

IVRCC proposed building one application to run both studies which would simultaneously collect data to be saved and stored for each separate protocol. Our unique Trial Administration Module completely and invisibly controlled access via the appropriate protocol’s separate data tables. Even with the same entryway portal to the two studies, we were able to accommodate one protocol’s dataset of uniquely identified sites, patients, randomization codes, medication lists and system users from the other by using unique IDs and credentials.

By not having to run two distinct and parallel applications, the client was able to administer both studies with lower build, hosting, and maintenance costs. This innovative solution resulted in a savings of tens of thousands of dollars for our client.

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Download the Case Study Here