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The Assumption-Reality Paradox
Acute pain trials start with assumptions. How you execute—when reality sets in—determines the outcome. When you’re designing an acute pain clinical trial, it’s perfectly normal to have some early assumptions […]
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Regulatory Friction You Don’t See Coming in Clinical Development
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 […]
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When Early Decisions Shape Late-Stage Risk
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 […]
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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 […]
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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 […]
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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 […]
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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. […]
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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 […]
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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.
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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?
Maximizing the Use of Real-World Data (RWD): Beyond the Theory
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?
Splitting SDTM Datasets Using a Data Cutoff for Submission
In complex or longer duration clinical studies, it is common to submit the data up to a predetermined date, often known as the Data Cutoff Date. We will discuss how data cutoff is implemented in SDTM database, since SDTMs are the source data for submission.
New Drug Applications – When is it ok to not submit data to FDA?
New Drug Applications – When is it ok to not submit data to FDA? Generally speaking, the FDA wants to see all data collected during drug development – all clinical trials, across all indications, using any formulation of your drug, in any region of the world.
Successful Pediatric Investigation Plan (PIP) Application in the European Union – Part 1: Understanding the regulatory requirements
Regulation (EC) No 1901/2006 (the “Pediatric Regulation”) introduced the obligation for Sponsors to apply for a pediatric investigation plan (PIP) early in the drug development process and conduct their pediatric clinical trials accordingly to a PIP agreed with the EMA. Compliance with the Pediatric Regulation is mandatory for any Sponsor seeking marketing authorization for a new medicinal product in the EU.
Accelerated Approval Pathway Now Has Procedures for Expedited Withdrawal: Insights from FDA’s New Draft Guidance
The accelerated approval pathway has been instrumental in bringing groundbreaking therapies to patients facing serious or life-threatening conditions.
Should I up-version study SDTM and ADaM when it becomes time to submit a marketing application?
Do I need to up-version to the most recent versions of the standard from the current Catalog when preparing to submit clinical study data? How can I figure this out? Check out the latest blog from Rho to find out.
Best Practices for Hardcoding Clinical Trial Data
In clinical trials, the accuracy and integrity of data are paramount. While the goal is to handle data systematically and programmatically, there are occasions when hardcoding becomes necessary. Note the following considerations for when to hardcode and the importance of documenting these decisions.