CDISC SDTM mapping made simple Is a drug working? Are there side effects? Is it safe to continue with a trial? These questions can be answered by clear, comprehensive data analytics. But to get this information, you must first produce quality CDISC SDTM datasets. Mapping your clinical trial data to CDISC’s SDTM format is no … Continued
Voice of the Customer Founded in 2016, Zhejiang Longcharm Biomedicine Technology Co., Ltd. provides one-stop R&D outsourcing services for the Chinese pharmaceutical industry. They can support BA/BE/PK clinical testing and data analysis services that comply with Chinese and American regulatory requirements for both novel and generic drug development programs. In 2023 July, Zhejiang Longcharm Bio-medical … Continued
When you think of clinical data standardization, you might think of forms and datasets, or of CDISC’s CDASH, SDTM and ADaM models. And while these are an excellent and necessary starting point for standardization, it’s important to understand the many other ways you can use standardization to improve the efficiency of your clinical trials. Clinical … Continued
New therapeutics development in rare diseases presents both opportunities and complexities. Because of the small patient pool available in these indications, there are challenges in designing and conducting clinical trials and the data interpretation that follows, and the ultimate path to registration. The top 3 critical downfalls in rare diseases development include Poor understanding of … Continued
Create effective CRFs using our comprehensive design checklist Simple yet effective Case Report Forms (CRFs) are crucial to the success of a clinical trial. Quality CRFs reduce the chance of mistakes or ambiguity in collected data, or redundant data collection. Our CRF design checklist can help you create high quality CRFs that meet all the requirements … Continued
As the clinical research industry moves towards more efficient and automated processes, clinical metadata repositories are becoming a must. You’ve probably heard of them; sometimes they are referred to as ‘clinical MDRs’ or simply ‘CMDRs’. But you might not know exactly what they do and how they can make your clinical study build more efficient. … Continued
Whether you want to expand your knowledge of CRFs in clinical trials, or learn the dos and don’ts of CRF design, you’ve come to the right place! Let’s start with the basics. What are case report forms? A case report form (CRF) is a document designed to record all patient information that needs to be … Continued
Unlocking Efficiency in Drug Development with Simcyp PBPK Modeling Complex drug-drug interactions (DDIs) are a significant roadblock in drug development. While crucial for safety, traditional methods like extensive clinical trials can be time-consuming, cost millions of dollars, and delay the delivery of potentially life-saving treatments to patients in need. This white paper introduces Simcyp PBPK … Continued
Clinical trials play a crucial role in advancing medical research and improving patient outcomes. The effectiveness of studies relies heavily on cutting-edge technology to optimize and accelerate the study build and submission processes. In this blog, we look at some of the innovative software solutions revolutionizing the way researchers design, manage, and analyze trials. Armed … Continued
Find out all you need to know about CDISC SDTM, from the SDTM implementation guide to a step-by-step process for SDTM dataset creation.
