With Pinnacle 21’s clinical data validation software Provision of accurate, compliant clinical trial data is essential for submission to regulatory agencies like the FDA and PMDA. Without correct data, you risk costly delays – and worst case scenario, a failed submission. But with Pinnacle 21 (P21), you can be confident your study data is … Continued
https://www.certara.com/pinnacle-21-enterprise-software/validation/The eCTD v4.0 standard introduces several changes to the submission process, including updated granularity, context groups, re-used files, and more. The change will require new habits and new technology, but one upside is better harmonization across regulatory agencies. Join our webinar to discuss some of the nuanced changes in the v4.0 standard and discover how … Continued
https://www.certara.com/webinar/ectd-4-0-new-standard-new-technology-new-opportunities/Location: BeiGene Innovation Center (Xinghan 2nd Road, International Bio-Island, Huangpu Zone, Guangzhou) In the field of modern biomedicine, the development of innovative drugs faces unprecedented challenges. Drug discovery is characterized by long lead times, high costs, and low success rates. In order to overcome these core challenges, this workshop will focus on the topic of … Continued
https://www.certara.com/live-events/using-model-informed-early-development-to-attack-the-core-challenges-of-innovative-medicines/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.
https://www.certara.com/blog/dont-miss-our-inaugural-event-for-biosimulation-users/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
https://www.certara.com/blog/everything-you-need-to-know-about-crfs-in-clinical-trials/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
https://www.certara.com/white-paper/pbpk-for-drug-drug-interactions-ddi/Automate creation of define.xml – without coding Define-XML is a mandatory part of your regulatory submission for SDTM, SEND and ADaM datasets. But preparing your define.xml files, dataset metadata, aCRF, and reviewer’s guide, is a time-consuming manual task. Many studies fail because of faulty define.xml files. So, you need to make sure your submission is … Continued
https://www.certara.com/pinnacle-21-enterprise-software/define-xml/Learn how drug discovery tools can help pharmaceutical industry professionals make more informed decisions based on robust data analytics
https://www.certara.com/blog/how-drug-discovery-tools-aid-pharma-decision-making/