Automate Your Patient Narratives for Clinical Study Reports | Synchrogenix Writer

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

Biostatisticians | Protect Your SAS, R, & Python Data Integrity

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

What is BaseCase?

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.

Your First Choice in Complex Biologics Drug Development

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.

When you have a spot, get your shot!

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

PK Submit CDISC Technology

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).

Accelerating Medicines & Vaccines Using Virtual Patients

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

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