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/The proliferation of AI models and GPTs has revolutionized how the life sciences industry consumes information and uses it for accelerating and validating research. By leveraging GPTs, researchers can complete what would normally be weeks long literature review and data extraction tasks in a matter of minutes or hours. In this webinar, Certara’s experts will … Continued
https://www.certara.com/on-demand-webinar/the-state-of-ai-in-in-silico-trials-and-drug-development-the-practical-application-of-ai-in-qsp-apac-webinar/Cleansing, mapping, programming and QC of in-scope nonclinical study data are all critical pieces of the regulatory submission process for both FDA Investigational New Drug (IND) Applications and New Drug Applications (NDAs). Certara’s expert biostats programmers provide submission ready CDISC SEND datasets and supporting documentation; these services are often utilized by biopharma companies without dedicated … Continued
https://www.certara.com/services/send-dataset-services-for-fda-ind-submissions/The impact and acceptance of Physiologically-Based Pharmacokinetic (PBPK) modelling continues to exhibit strong growth within the pharmaceutical industry, and PBPK approaches are increasingly being advocated by regulatory agencies to streamline drug development. The US FDA has released its draft guidance on this in Oct 2020: ‘The Use of Physiologically Based Pharmacokinetic Analyses.’ PBPK or Physiologically-Based … Continued
https://www.certara.com/live-events/workshop-in-japan-simcyp-biopharmaceutics-recent-advances-and-applications/Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content for drug development and regulatory submissions.
https://www.certara.com/blog/why-medical-writing-services-use-style-guides-lexicons/Report Review & Literature Screening A pharmaceutical company receives large volumes of unstructured documents from CROs, partners and departments across the organization that hold valuable data related to product attributes and the manufacturing life cycle. Manually analyzing these documents requires 2+ employees and 1+ full day of work per project, impacting over 200 total days of productivity … Continued
https://www.certara.com/certara-ai-real-world-applications/Accelerate data ingestion to submission with Pinnacle 21 It can be a challenge just getting external vendor data supplied in a reasonable timeframe! And even when you have it, typically a lot of work is needed to ensure data integrity and regulatory compliance. The data must be validated, reconciled and transformed into the correct structure … Continued
https://www.certara.com/pinnacle-21-enterprise-software/external-vendor-data-exchange/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
https://www.certara.com/blog/how-clinical-trial-software-helps-make-studies-more-efficient/The Quantitative Systems Pharmacology (QSP) Summit is a free conference dedicated to fostering an active community of industry and academic participants interested in topics relevant to QSP. In its seventh year, the QSP Summit is a one-day event featuring talks from key industry and academic researchers, a poster session, and networking time with peers. Date: May … Continued
https://www.certara.com/live-events/quantitative-systems-pharmacology-qsp-summit-cambridge-2024/