What are biosimilars & how are they developed?
Learn about biosimilars, their benefits for patients who take biologic drugs, and how pharmaceutical companies demonstrate their bioequivalence to approved biosimilars.
Category: ブログ
An Endogenous Biomarker for Predicting OATP1B DDIs
This blog reviews the role of the endogenous biomarker, CP-1, for assessing OATP1B transporter-mediated drug-drug interactions and their clinical implications.
What Should a Clinical Metadata Repository Do?
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
What’s Driving the Increased Demand for SEND Dataset Services?
Gain an understanding of CDISC SEND dataset creation challenges impacting the biopharma industry, and how these factors could delay regulatory submissions and strategic initiatives.
Don’t Miss Our Inaugural Event for Biosimulation Users
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.
Everything You Need to Know About CRFs in Clinical Trials
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
How Drug Discovery Tools Aid Pharma Decision-Making
Learn how drug discovery tools can help pharmaceutical industry professionals make more informed decisions based on robust data analytics
Why Medical Writing Services Use Style Guides & Lexicons
Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content for drug development and regulatory submissions.
How Clinical Trial Software Helps Make Studies More Efficient
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
Everything You Need to Know About SDTM
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.
