Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator models describe the behavior of drugs in different body tissues and includes genetic, physiological and epidemiological databases that facilitate simulations in virtual populations. The Simcyp Simulator has been used to inform more than 250 label claims for 85+ novel drug approvals by the US Food and Drug Administration (FDA). … Continued
This recording shows an overall review of RsNLME using Pirana and an extensive explanation on how to use RsNLME from the command line. The recording also shows the new reporting capabilities with ModelResults and VPC Results added with RsNLME 1.1.
Reduce time to completion while providing consistency across your batches of patient safety narratives Managing your patient narrative projects with moving timelines is challenging, especially given the complexities that go into preparing your data for use. With the patient narrative building features in Certara’s Synchrogenix™ Writer, you can manage thousands of patient safety narratives to … Continued
Are you utilizing a 21 CFR Part 11 compliant repository for your SAS, R, & Python data? Certara Integral data repository is designed to be a 21 CFR Part 11 compliance bolt-on solution to your existing statistical computing environment. This means Integral is compatible with your cloud-based and on-premise computing environments and is agnostic to … Continued
Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams is a time-consuming, expensive, and often decentralized process. BaseCase is “no-code” platform that enables you to visualize large complex datasets and economic models, which demonstrates the value of products to key decision-makers.
Meet Rachel Bombara, Sr. Regulatory Operations Specialist at Certara Synchrogenix. In this brief video Rachel shares how she manages tight deadlines and how she leverages technology to support her daily submission work.
The pharmaceutical has made massive investments in complex biologics, a drug class that includes oligonucleotide therapeutics, immuno-oncology therapies, vaccines, antibody-drug conjugates, bispecific antibodies, and cell and gene therapies. These drugs can be challenging to develop for multiple reasons. Certara provides strategic approaches needed to optimize dosing, trial designs, payer plans, and regulatory strategy.
Vaccines are one of the greatest medical innovations. Worldwide, millions of lives are saved every year due to vaccines, which reduce disease, disability, and death from infectious diseases. Regulatory-approved vaccines go through rigorous clinical testing to show that they are safe and effective. We can all do our part by getting vaccinated. So when you … Continued