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. […]
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 […]
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.
Most of those who work with Clinical Data Interchange Standards Consortium (CDISC) datasets have probably heard of the term “traceability.” But why is it important and how can it best be implemented?
Real-world data (RWD) has become a buzzword phrase in recent articles in clinical trial research. But there is often a difference between the idealistic and future use of RWD and how it can and is practically being used to advance drug development. What is RWD? How is RWD being applied now? What are the potential uses for it in the future?
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.
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
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.
Most of those who work with Clinical Data Interchange Standards Consortium (CDISC) datasets have probably heard of the term “traceability.” But why is it important and how can it best be implemented?
Real-world data (RWD) has become a buzzword phrase in recent articles in clinical trial research. But there is often a difference between the idealistic and future use of RWD and how it can and is practically being used to advance drug development. What is RWD? How is RWD being applied now? What are the potential uses for it in the future?
