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Blog Post
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.
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.
News
Breaking New Ground in Food Allergy Treatment: Xolair Approval
Nicole Rogers, Associate Director, Project Management, shares a powerful perspective on what it means to be part of the OUtMATCH study, a groundbreaking food allergy study that supported the approval of Xolair.
News
Clinical Trial Enrollment Caps: What They Are and When to Use Them
What’s the secret to optimizing your clinical trial? It could be understanding enrollment caps and knowing exactly when to set them.