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 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. 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 few reviewers extremely efficient. 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.—October 27, 2020. 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
Speaker: 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
By Theresa Shalaby, MSN, RN Engaging the patient is key to support clinical trial recruitment and have truly patient-centric drug development. Writing for patients and the general public is vastly different from writing for regulatory authorities or clinicians. Plain language summaries (PLS) of clinical trial results ensure that study participants are informed about study results and … Continued
