Broadens European footprint with integrated regulatory services and statistical analysis PRINCETON, NJ.— 2021年3月2日– 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 data to global pharmaceutical and biotechnology companies. Founded in 1998, AUTHOR! is based near Amsterdam … Continued
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 therapy products supply chains and manufacturing While many people working in the pharmaceutical industry can … Continued
“You would not be able to tell 40 different writers were authoring these. まるで一人の担当者がすべて仕上げたかのように見えました。どのライターたちもシステムを活用して合理的かつ視覚的にまとまった一貫性のあるストーリーを書いていたので、数人しかいないレビュアーたちは非常に効率的に大規模なセットをレビューすることができました。This software is extremely valuable.” — Associate Director, Medical Writing … Continued
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 and potential discrepancies in the reporting of a drugs safety. Fortunately, through the advancement and use … Continued
By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and the following information will address a few popular topics. Health Canada implements eCTD for Clinical Trial Applications Health Canada accepts electronic Common Technical Document (eCTD) … Continued
Certara strengthens transparency and disclosure leadership with launch of new Podium™ platform for patient engagement and appointment of industry veteran PRINCETON, N.J.—2020年10月27日. Certara, a global leader in biosimulation, today announced that its regulatory science division, Synchrogenix, continues to build on its clinical trial transparency and disclosure position by introducing a new technology platform … Continued
講演者：Nirpal Virdee, Global Head, Transparency & Disclosure
Without careful execution and the ability to navigate unexpected challenges, marketing application submissions are prone to falling off track and costing valuable time and resources… and sleep. In this webcast, you’ll learn best practices for a marketing application submission which can be a significant undertaking. Regulatory experts will offer tips and guidance for acceleration, submission … Continued
As the regulatory submissions landscape evolves under pressures of COVID-19 related delays and new/updated regulatory agency requirements, companies must become more agile in evaluating current regulatory strategies. This webcast will feature an overview of best practices to create successful eCTD submissions in a rapidly changing environment. Learn how to evaluate current operational workflows and eCTD … Continued
