Our Blog
Blog Post
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.
Blog Post
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.
Blog Post
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.
Blog Post
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.
Blog Post
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.
Blog Post
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?
Blog Post
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.
Blog Post
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?
Blog Post
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.
Blog Post
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.