Narratives are an integral part of medical writing. Sponsors sometimes need to prepare large batches of these deliverables in a short period while most traditional methods prove unsuccessful in providing both consistency and quality. This can lead to questions...
Abstract During a pandemic caused by a novel pathogen (NP), drug repurposing offers the potential of a rapid treatment response via a repurposed drug (RD) while more targeted treatments are developed. Five steps of model‐informed drug repurposing (MIDR) are discussed:...
“You would not be able to tell 40 different writers were authoring these. It looked as though one person was writing them! The writers wrote a streamlined and visually-cohesive and consistent story that made reviewing the large set by only...
A global biotechnology company engineering precision genetic medicine for rare diseases was in need of expertise in early assessment of proposed clinical trial designs and their potential payer coverage. They engaged with Certara’s Cell & Gene Therapy practice because of...
By: James Zoshak The COVID-19 pandemic has added increased risk and uncertainty to gene therapy supply chains. To mitigate this risk, it is critical for biopharmaceutical manufacturers to properly maintain the documentation governing their continuity of operations. It’s complicated: Gene...
Broadens European footprint with integrated regulatory services and statistical analysis PRINCETON, NJ.— March 2, 2021– Certara, Inc., a global leader in biosimulation, today announced the acquisition of AUTHOR!, a company that provides medical writing and statistical analysis of clinical trial...
Certara's Dr. Piet van der Graaf, Senior Vice President, Professor of Systems Pharmacology, Leiden University, and Editor-in-Chief of Clinical Pharmacology and Therapeutics presents the opening lecture for Pharmacology 2020.
In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management software for their electronic common technical document (eCTD) submissions. The regulatory team at Prelude Therapeutics is very lean and responsible for more than 30 submissions...
© 2025 Certara. All Rights Reserved. | Privacy policy
