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Early in clinical development, it’s easy to focus on what’s directly in front of you. After all, your goal is to hit milestones, generate strong data, and keep the program […]

How confident are you that your acute pain study will behave the way it’s designed to? In planning sessions, most protocols look neat and predictable. But the moment your study […]

Early clinical decisions shape regulatory risk and the path to approval   Assumptions about study design and real-world execution don’t stay contained to a single milestone. Over time, they influence […]

Four scientific principles. One unifying concept. The Cohesion Effect experience. SCOPE Summit is a place where innovation thrives. Thousands of attendees and hundreds of exhibitors from around the world, all […]

When Tonix came to us, the stakes were high, and the timelines were tight. Their goal? To submit a New Drug Application (NDA) for TONMYA™ and, for the first time […]

Every CRO out there will tell you they’re site-centric, and on pitch decks, they use the right buzzwords to prove it.  Curious. Collaborative. Dependable. Problem-solvers. Sound familiar?   That’s great in […]

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. […]

Picture this: a complex trial is running, but it has been plagued with issues from the start. From multiple delays to cost overruns, and now with quality concerns creeping in—it […]

ICH E6(R3) is here, and with it, clinical teams are bracing for the impacts. Biotechs are being asked to develop clear and concise protocols, demonstrate oversight throughout the trial, integrate […]

Behind every enrollment milestone is a web of relationships—some strong, some strained, and some that make all the difference. At Rho, we don’t just talk about site engagement. We live […]