Almac IRT solution designed to speed startup

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The company’s Simplify technology is designed to help sponsors and CROs reduce the time required to launch a clinical trial.

Almac Clinical technologies has launched Simplify, an interactive response technology (IRT) offering designed to let sponsors and contract research organizations launch trials more quickly. It enables users to conduct patient randomization, site and drug supply management, reportedly in much less time than traditional solutions.

Matt Cocking, Almac’s director of marketing, told Outsourcing-Pharma that Simplify improves upon previous IRT solutions by offering a higher degree of flexibility, enabling the product to be deployed more quickly and used more nimbly.

From the onset, the goal was to provide a high-quality, rapidly deployed IRT that can accommodate a long list of study permutations and protocol amendments at any time,” Cocking explained. “Our IRT design consultants will evaluate your study objectives and ensure we’re providing the right solution.

The company analyzed more than 3,000 clinical trials supported with other Almac IRT solutions to pinpoint the most commonly requested and critical IRT functions. Additionally, Cocking told us, the company drew upon input from client and industry professionals.

Our product strategy committee really took note of the recurring theme that I mentioned previously: the frustration trial sponsors felt when they need a straightforward approach to patient randomization and trial supply management without the need for an extensively customized system, and couldn’t find exactly what they’re looking for. That was our starting point,” he said.

Valarie Higgins, Almac president and managing director, said Simplify offers the flexibility necessary to enable users to scale the solution whenever the needs of a trial warrant.

Unplanned, or unexpected, protocol changes that require custom solutions can be swiftly implemented without requiring a major redesign, and are guided by our expert team of biostatistical, integration, design and support consultants,” she said.

Simplify is built upon Almac’s IXRS 3 customizable IRT platform. IXRS 3 was chosen as the foundation for Simplify, Cocking said, because of its robust architecture and extensive capabilities.

The end result is a high-quality IRT solution that can accommodate a vast array of protocol designs, yet doesn’t require trial sponsors and CROs to spend so much time in meetings with their suppliers,” he said.

Cocking related an example of a customer who wanted to launch a COVID-19 trial and get the first patient in within 14 days.

We identified Simplify as the right approach and walked them through the capabilities. The next morning, we were given the green light, and within seven business days were ready to hand over the finished product to that sponsor,” he said.