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 ..read more

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 ..read more

Learn about biosimilars, their benefits for patients who take biologic drugs, and how pharmaceutical companies demonstrate their bioequivalence to approved biosimilars ..read more

Gain an understanding of CDISC SEND dataset creation challenges impacting the biopharma industry, and how these factors could delay regulatory submissions and strategic initiatives ..read more

This blog reviews the role of the endogenous biomarker, CP-1, for assessing OATP1B transporter-mediated drug-drug interactions and their clinical implications ..read more

Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best practices for addressing them ..read more

Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content for drug development and regulatory submissions ..read more

Learn how drug discovery tools can help pharmaceutical industry professionals make more informed decisions based on robust data analytics ..read more

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 ..read more

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 ..read more