2 min read
Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies' interactions with global health authorities. Over the past two decades, eCTDs have evolved from a basic electronic substitute for paper to a robust, standardized...
2 min read
Medical writing plays an essential role in clinical development and regulatory approval. As scientific advancements grow more complex, well-structured documentation ensures the success of clinical trials, facilitates regulatory review, and accelerates...
3 min read
Many sponsors underestimate how much support the Food and Drug Administration (FDA) can offer during early drug development, often believing they need more data than is truly required before engaging. But once your proof-of-concept data, clinical...
3 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
5 min read
The FDA recently released a draft guidance on the use of multi-regional clinical trials (MRCTs) in oncology research. A well-planned MRCT can be an efficient approach to the global clinical development of a novel product, allowing for access to a wider...
3 min read
Data Monitoring Committees (DMCs) play a vital role in clinical trials by providing independent oversight to ensure patient safety, maintain scientific validity, and uphold data integrity. With clinical trials becoming increasingly complex, especially...
3 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
1 min read
The U.S. Food and Drug Administration (FDA) is undergoing significant change. Recent announcements have highlighted budget constraints, hiring freezes, and reductions in force (RIFs) across federal health agencies, including the FDA. These shifts have...
2 min read
We’re hearing more and more about the value of radiopharmaceuticals in medicine today—but what does it take to ensure their safe and effective development throughout a clinical trial?
2 min read
Real-world evidence (RWE) offers the potential to serve as a valuable tool in regulatory decision-making, offering insights derived from the real world that can complement traditional clinical trials. By capturing data from diverse sources such as...