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What I Brought Back from PAINWeek 2026
Attending PAINWeek this year was especially meaningful because pain research has been a major part of my career. Over the past 12 years, I have worked on more than 50 […]
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The Parkinson’s Trial Alignment Principle
Staying cohesive through long and complex Parkinson’s disease trials Parkinson’s disease trials, like most clinical trials, are rarely a straight path from start to finish. Protocols evolve, real-world conditions change, […]
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The Real-World Dynamics Dilemma
Six challenges in acute pain trials and one differentiator—coordinated execution We’ve all been there before. Your acute pain trial strategy is sound, the protocol looks solid, and everything progresses as […]
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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. […]
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.
Bringing a Medical Device or Drug to Market-Part 2: How to Use the Request for Designation (RFD) Process to Classify Your Product
Distinguishing between a medical device and a drug may be challenging to define for some products. We turn our attention to a crucial tool that Sponsors may use to have the FDA classify your product: the Request for Designation (RFD). In this blog, we’ll describe what an RFD entails and its significance in the regulatory realm, providing a comprehensive overview of the process.
Blinded Variance Estimation Sample Size Adjustments
Interim sample size adjustments and their many approaches are a frequent discussion point between Sponsors and statisticians during protocol development. One such approach is a blinded assessment of variance, favored by some Sponsors for its lack of alpha penalty. We will discuss how this method works, the pros, the cons, and if this approach might be appropriate for your protocol.
Implementation of ICH M12 Guidance in 2024: What’s New for Drug Interactions?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted a harmonized drug-drug interaction (DDI) guidance (ICH M12) in May 2024. The next step is for this guidance to be implemented by ICH members; the FDA and EMA have already implemented the guidance. Read our blog for key highlights of the 2024 ICH M12 Guidance.
FMQs vs SMQs
Sponsors often rely on Standardized MedDRA Queries (SMQs) to group adverse events for detection of safety signals across clinical trials. Additionally, the FDA has introduced their own version of adverse event groupings – FDA MedDRA Queries (FMQs). So, what’s the difference?
Successful Orphan Drug Designation Application in the European Union
Are you developing a new medicinal product for a rare disease and interested in applying for orphan drug designation (ODD) in the European Union (EU)? This blog lists the main areas that you will need to address in your ODD application.
Diversity Action Plans: A New Requirement for Phase 3 Clinical Trials. Are You Ready?
Diversity Action Plans will soon be required for phase 3 clinical trials and other pivotal studies of drugs and biological products conducted in the US. Are you ready for this requirement?
Statistical Challenges with Site Enrollment in Clinical Trials
Did you know that insufficient enrollment is the leading cause for clinical trials being halted? Study sponsors rightly embrace those sites which are high performing as they give a study the best opportunity to meet its enrollment targets. However, is it possible for there to be overreliance on these high enrolling sites? Unfortunately, the answer is yes.