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
As seen on CNBC** Certara is the global leader in biosimulation, a powerful and proven technology. We transform traditional drug development by helping our customers create safe and effective medicines, faster. Certara (CERT) is proudly listed on Nasdaq.
PK Submit automates the time consuming, error-prone and complex task of creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions. It allows you to automatically create a complete electronic regulatory submission-ready package within minutes during the normal process of setting up and executing a non-compartmental analysis (NCA).
Children, the elderly, pregnant women, and other different populations may need different medication and vaccine doses to optimize safety and efficacy. But using conventional clinical trials to determine dosing for different populations can be difficult for ethical and logistical reasons. Virtual patients that vary physiologically can be used to understand how new vaccines and medicines … Continued
Pharmacyclics’ (now AbbVie) Imbruvica (ibrutinib) is an anticancer drug targeting B-cell malignancies. Leveraging the US FDA’s accelerated approval programs, the company generated PBPK models using the Simcyp Simulator to inform dose, dosing regimens, and DDIs. Approved initially for mantle cell lymphoma as a breakthrough therapy, Imbruvica is now approved for multiple uses, including first-line CLL.