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
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
Every CRO claims to value sites. But the true nature of their site relationships could determine the outcome of your trials. You deserve a partner that builds site relationships the
For the first time, some children with life-threatening food allergies can safely eat in the school cafeteria and celebrate at a friend’s birthday party without fear of accidental allergen exposure. That’s not just progress—it’s the kind of outcome that reshapes lives and changes what’s possible in clinical development.
According to the Study Data Technical Conformance Guide (October 2024), sponsors should prepare a document called the study data standardization plan (SDSP) for each of their development programs to describe the submission of standardized non-clinical and clinical study data to the FDA.
