This blog reviews the role of the endogenous biomarker, CP-1, for assessing OATP1B transporter-mediated drug-drug interactions and their clinical implications.
https://www.certara.com/blog/an-endogenous-biomarker-for-predicting-oatp1b-ddis/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
https://www.certara.com/blog/what-should-a-clinical-metadata-repository-do/Since the FDA passed regulations requiring submitted datasets to be compliant with the CDISC Study Data Tabulation Model (SDTM), clinical trial sponsors have faced a dilemma. Should they design electronic case report forms (eCRFs) in line with SDTM from the outset? Or should they retrospectively convert data to CDISC SDTM at the end? A retrospective … Continued
https://www.certara.com/on-demand-webinar/optimizing-the-quality-of-cdisc-sdtm-compliance-apac-webinar/Gain an understanding of CDISC SEND dataset creation challenges impacting the biopharma industry, and how these factors could delay regulatory submissions and strategic initiatives.
https://www.certara.com/blog/whats-driving-the-increased-demand-for-send-dataset-services/Scientists in drug discovery often spend excessive time managing research data instead of concentrating on identifying the most promising compounds for new drugs. The right technology streamlines the drug discovery process, providing a seamless workflow for data-driven design, analysis, and research tracking of small molecules. In this webinar, experts from Certara and Chemaxon will guide … Continued
https://www.certara.com/webinar/closing-the-loop-how-to-improve-the-management-of-your-design-make-test-analyze-cycle/Transcript: Did you know that eighty percent of life sciences data is unstructured? This data is messy, difficult to search, often resides in silos. Having unstructured data means that you could be missing valuable insights that can inform prioritizing new molecules for designing, executing, or submitting clinical trials. The proliferation of powerful AI models such … Continued
https://www.certara.com/video/certara-ai/In this episode of Certara Talks, Jeff Abolafia, Kristin Kelly, and Julie Ann Hood recap their fantastic presentations from PHUSE US Connect earlier this month. The team covered inspirational and innovative topics, and Julie Ann and Jeffrey won Best in Stream for their presentations ‘Sowing Seeds of Inspiration: Letters to a Pre-Scientist’ and ‘Future Clinical … Continued
https://www.certara.com/video/certara-talks-phuse-2024-recap/Transcript:In pharmaceutical research and development, R&D, companies utilize biosimulation and PBPK modeling technologies to identify and develop new therapeutic agents. Biosimulation technology holds immense potential for expediting FDA approvals while predicting toxicities and drug to drug interactions. Within the field of oncology, kinase inhibitor drug have shown efficacy in targeting complex diseases with over fifty … Continued
https://www.certara.com/video/precision-predictions-simcyp-simulator-for-kinase-inhibitors/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/