EudraCT has been Europe’s clinical trial database for almost twenty years. But, now it’s the time to say goodbye to EudraCT and hello to the new Clinical Trial Information System (CTIS). CTIS will be the single entry point for submitting, assessing, authorizing, supervising, and reporting clinical trials in all EU Member States (Figure 1). It … 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
In the ever-evolving pharmaceutical landscape, advancing drug development requires innovative tools that seamlessly integrate science and regulatory standards. The release of Simcyp™ PBPK Simulator Version 23 provides an even more comprehensive platform for all stages of drug development. Physiologically Based Pharmacokinetic (PBPK) modeling is a cornerstone in drug development, providing predictive insights into drug behavior … Continued
Learn about biosimilars, their benefits for patients who take biologic drugs, and how pharmaceutical companies demonstrate their bioequivalence to approved biosimilars.
This blog reviews the role of the endogenous biomarker, CP-1, for assessing OATP1B transporter-mediated drug-drug interactions and their clinical implications.
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
Gain an understanding of CDISC SEND dataset creation challenges impacting the biopharma industry, and how these factors could delay regulatory submissions and strategic initiatives.
Join us for an in-person event where you can learn from drug development experts, network with peers, and discover the latest trends and best practices in biosimulation.
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
Learn how drug discovery tools can help pharmaceutical industry professionals make more informed decisions based on robust data analytics
