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Blog Post
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.
Blog Post
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?
Blog Post
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?
Blog Post
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.
Blog Post
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.
Blog Post
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.
Blog Post
Accelerated Approval Pathway Now Has Procedures for Expedited Withdrawal: Insights from FDA’s New Draft Guidance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.
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.