You’re responsible for showing risk oversight, protocol clarity, and a site-friendly design—but you’ve got a lean team, a looming trial, and no time to decode the 110-page ICH E6(R3) guidance.
Here’s the good news: You don’t need a 20-person QA team to run a compliant, audit-ready trial. You just need the right moves—and the right teammate. Take a few pointers from Rho’s ICH E6(R3) playbook.
Play 1: Check your quality essentials early and often
COACH’S TIP: R3 prescribes that you develop critical-to-quality factors and check your protocol against them. We identify risk early to minimize the downstream effects—with no added burden for you, just clarity.
Play 2: Oversight that speaks for itself
COACH’S TIP: R3 requires active sponsor involvement with clear documentation. We create frameworks for oversight that reduce noise and meet expectations.
Play 3: Design backward from the finish line
COACH’S TIP: R3 expects protocols to be devised with the end in mind. We have experts who can step in without taking over, sharpen the strategy, and design a protocol to get you where you want to be.
Play 4: Treat burden like a protocol risk
COACH’S TIP: R3 asks you to evaluate how the trial impacts sites and participants. We assess site feasibility and reduce friction before it can start any fires.
Play 5: Build your data system like a team, not a patchwork
COACH’S TIP: R3 calls for integrated systems that speak to each other—not ones patched together with digital duct tape. We unify platforms and optimize current systems so data flows and remains audit ready.
The gist is: You’re still responsible—even if you outsource. But Rho can confidently give you the strategy, systems, and support to meet R3 without burning out your lean team.
