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 […]
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 […]
On 26 April 2023, the European Commission (EC) proposed reforming the European Union (EU) pharmaceutical legislation. This revision constitutes the first major overhaul of the pharmaceutical legislation since 2004. It will adapt the legislation to the needs of the 21st century.
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.
Sponsors are generally aware of the commonly held Type B FDA meetings, from pre-IND to End of Phase 2 (EOP2) to pre-NDA/BLA, but how often do you take advantage of additional Type C meetings for agency feedback? Continued discussion and input from the agency can be very beneficial, even outside of the milestones that allow for a Type B Meeting.
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.
