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
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
Iberoamerican Pharmacometrics Network
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
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
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
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
Various methods exist to calculate the absorption profile. In this webinar, Dr. JM Cardot will explore the various methods while highlighting the advantages and drawbacks of each of them along with the prerequisites. It will also explore the risks of using already available data in combination with newly obtained data in a new group of … Continued
