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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.
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.
Marketing Application Reviews: Best Practices for Responding to Information Requests
Responding to information requests (IRs) from FDA during review of a marketing application can be stressful. How do you survive the rollercoaster of requests? We have outlined useful tips and best practices for managing responses to IRs during FDA review of your marketing application.
Overcoming statistical challenges in rare disease drug development
Regulatory agencies like the FDA require substantial evidence of the drug’s effectiveness for its intended use and sufficient information to conclude that the drug is safe. However, flexibility is given in how the standard can be met given the challenges associated with the limited number of subjects available in rare disease.
Where did the odds ratios go?
Reviewing recent FDA approvals, you may be struck by the total absence of odds ratios. Browsing the labels from the 2023 novel approvals, you can find proportions, differences in proportions, Chi-Squared analyses, CMH and variants, but logistic regression and odds ratios have practically disappeared from labeling. What gives?