Regulatory Operations Best Practices for Health Canada Submissions Blog Post
Health Canada submissions now require eCTD/CESG; regulatory operations expert support can streamline the process and ensure compliance.
Getting Real with RWE Press Coverage
By Taren Grom Real-world evidence, important for regulatory decision-making, is beginning to touch all areas of the healthcare value chain.
Certara’s Phoenix software supports training of the next generation of the pharmacometricians in China Press Coverage
The Pharmacy department of the Shanghai Chest Hospital is dedicated to developing and applying model-informed precision dosing (MIPD) and model-informed drug development (MIDD) models to optimize dosing for patients in China. Certara has partnered with Professor Jiao for 20 years...
Mechanistic model-informed discovery & development of bispecific antibodies for immuno-oncology: It takes 2 to tango On-Demand Webinar
More than 50 bispecific antibodies are in oncology clinical development with a large diversity in formats, directed at a range of immune and tumor targets. Bispecifics have demonstrated the potential for enhanced efficacy and reduced systemic toxicity. However, they are...
Certara Announces Pricing of its Upsized Initial Public Offering Press Release
PRINCETON, NJ.— December 10, 2020 – Certara, Inc. (“Certara”), a global leader in biosimulation, today announced the pricing of its upsized initial public offering of 29,055,000 shares of its common stock at $23.00 per share. Certara is offering 14,630,000 shares...
Be Honest, Be Reliable, Be Human: Insights from a Global Drug Development Expert Blog Post
One of the most exciting things about working in the pharmaceutical industry is the ability to meet and work with colleagues all over the world. In particular, China is one of the fast-growing centers for drug development. Indeed, a report...
The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries Publication
Alison Dillman,1 Michael J Zoratti,2 Jay JH Park,3 Grace Hsu,2 Louis Dron,2 Gerald Smith,2 Ofir Harari,2 Craig R Rayner,4 Noor-E Zannat,2 Alind Gupta,2 Eric Mackay,5 Paul Arora,6 Zelyn Lee,7 Edward J Mills2 A multitude of randomized controlled trials (RCTs) have emerged in response to the novel coronavirus disease (COVID-19) pandemic. Understanding the distribution...
“Where do I start?”: Strategies for selecting the first dose for human clinical trials White Paper
This guide to dose selection for first-in-human studies explains the conceptual framework, methods, and tools for extrapolating in vitro and animal study data to humans.
