TG Therapeutics Streamlines a Complex Phase 2 RTSM Build with Korio

Overview

TG Therapeutics’ Phase 2 study in generalized myasthenia gravis put the logic of several studies inside one protocol: multiple treatment pathways, blinded and open-label treatment, and a planned transition in how participants would move through the study. Daniel Betton, Director of Clinical Vendor and Program Management at TG Therapeutics, called it “one of the trickier IRT builds I’ve had to do.”

TG selected Korio for speed and expertise: a platform that could carry the protocol’s logic, and a service team that could mobilize immediately and decide at the pace the FPI date required. The build tested both, and Korio delivered the RTSM within TG’s target FPI date.

“Speed and expertise are the two big things, and Korio ticked both of those boxes for us.”

Daniel Betton
Director of Clinical Vendor and Program Management, TG Therapeutics

The Challenge

The RTSM decisions a protocol generates do not scale down with the size of the Sponsor running it. TG’s study carried the configuration complexity of a much larger program, and the question during startup was how much of that work the vendor would take on and how much would land on TG’s team.

Participants began with induction before moving into either blinded randomized treatment or open-label treatment based on clinical response. Later, the randomized phase would close and participant pathways would change again. The RTSM had to support those workflows, manage the supply requirements that came with them, and hold the blind wherever the protocol required it.

“There are several different avenues, almost like several studies in one, which makes it tricky from an IRT perspective,” said Betton. “There’s a lot of levers and switches that need to be pulled while maintaining a blind, and that makes it probably one of the trickier IRT builds I’ve had to do.”

TG also needed a vendor team that could move. Protecting the FPI date required prompt mobilization, quick decisions, and an RTSM ready for UAT on schedule.

The Korio Approach

A requirements review can run to hundreds of pages, and most of those pages describe standard system behavior rather than anything particular to the study in front of you. Korio brought established platform standards into the process, so TG’s review covered the decisions that were specific to the protocol: treatment pathways, dosing, and the planned phase transition.

“There are so many IRT builds where I’ve flipped through these pages thinking these shouldn’t be my decisions to make as a Sponsor,” said Betton. “Here’s a 150-page document, and maybe 20% of it is relevant. Cutting down that workload of document review was massive.”

Protocol knowledge and system knowledge in the same conversation

Korio’s service team worked through participant pathways, dosing requirements, and blinding considerations with TG, then configured the platform to support the design, adding functionality where the protocol called for it. Because the people on the call knew both the protocol and the platform, the team resolved questions in the call they came up in.

“The service team really understood the protocol, understood the complications, and married that with an understanding of your own system and product, and it made the build infinitely easier,” said Betton. “When we were discussing things on a call, we could get an answer immediately and make a decision immediately.”

Korio absorbed protocol changes without moving the go-live date

Korio’s configuration-driven approach took on protocol changes during startup while TG’s target go-live held. The service team assessed each change with TG and translated it into system requirements that matched the protocol and the operational workflow the study team intended.

The site interface factored into the decision

Site experience weighed on TG’s evaluation, and Betton pointed to the Korio interface as a strength.

“What sites think is a pretty huge decision maker for us, and the user interface of Korio is well beyond any other IRT I’ve personally experienced,” he said. “It’s simple, it’s clean, it’s fast.”

The Outcome

Korio delivered the RTSM within TG’s target FPI date and took on changes during startup.

What TG noticed was where the work sat. A build with this much conditional logic can consume a large share of a Sponsor team’s startup capacity in document review and decision escalation. On this study it did not, which kept TG’s team on the clinical and operational questions the protocol actually raised.

“I would absolutely recommend Korio as a system other biotech partners should consider. I think they’d be pretty happy with what they find.”

Daniel Betton
Director of Clinical Vendor and Program Management, TG Therapeutics