Blog
Rho’s Annual March of Dimes Activities
Read More
Explore Blog
Find what matters to you
Blog
“What Non-statisticians Need to Know about Statistics in Clinical Trials” Follow Up
Read More
Blog
Conducting CNS Clinical Trials? Overview and Considerations of the New Tools from NIH for Assessment of Neurological and Behavioral Function
Read More
Blog
Choosing the Right System for your Clinical Trial: Understanding the Differences between EDC and IVR/IWR
Read More
Blog
FDA Issues Draft Guidance on Developing Drugs for Treatment of Early Stage Alzheimer’s Disease
Read More
Blog
4 Types of Dose Finding Studies Used in Phase II Clinical Trials
Read More
Blog
4 Types of Efficacy Outcomes to Consider in Phase II Clinical Trials
Read More
Blog
5 Ways Smart Animal and Manufacturing Work Can Mitigate Risks to Your Clinical Development Plan
Read More
Blog
Thoughts from Rho’s CEO: Fostering Innovation in a Clinical Research Organization
Read More
Blog
Thoughts from Rho’s CEO: Our Commitment to Outstanding Customer Service in Clinical Trials Services
Read More
The Cohesion Museum Convergence
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
The Sponsor and CRO Symbiosis Effect: How cohesion carried us through a high-pressure NDA
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
The CRO Decoder: What Site-Centric Really Means (And What it Doesn’t)
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
The Lean Team Playbook: How small biotechs can nail ICH E6(R3) without a large QA team
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.
The MythBusters Revelations: Debunking compliance myths to keep your trial on track
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
Reform of the European Union Pharmaceutical Legislation (Adoption Stage TBD)
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.
Making History: Supporting Breakthroughs That Change Lives
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.
Taking Advantage of a Type C FDA Meeting for ISS Planning
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.
Study Data Standardization Plan (SDSP) – What it is and why it’s needed?
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.
Traceability: The Breadcrumb Trail of Clinical Trial Data
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?