Certara Launches New Synchrogenix ™ Writing Software to Speed Up Regulatory Submission Process | Your money
PRINCETON, NJ, September 30, 2021 (GLOBE NEWSWIRE) – Certara, a global leader in biosimulation, today announced the launch of Synchrogenix â¢ Writer, a new regulatory SaaS product that speeds up writing and reviewing patient stories . Patient stories describe adverse events or adverse drug reactions and are essential for clinical study reports in all therapeutic areas throughout clinical phases.
âIn today’s automated and standardized clinical and regulatory processes, writing patient stories remains primarily a manual process,â said Daniel R. Matlis, Founder and President of Axendia, a leading analyst firm. plan in the life sciences sector. âAs the number of clinical trials increases worldwide, this approach is not sustainable. The availability of a product like Synchrogenix Writer provides life science organizations with a solution to help automate the writing process, thereby shortening the regulatory filing time.
The traditional manual narrative writing process is long and expensive due to the integration of information from various sources, large writing teams, and multiple rounds of drafts and revisions. Led by Certara’s regulatory drafting experts, Synchrogenix Writer software automates data mapping and enables earlier drafting before database lockdown, resulting in increased consistency, reduced risk, and delay. expedited regulatory filing.
âManaging patient narrative projects with tight deadlines is a challenge, especially given the complexity of preparing important clinical documents to meet regulatory requirements,â said Leif E. Pedersen, president of software at Certara. âWith Synchrogenix Writer, organizations can manage thousands of patient stories in a fraction of the time while ensuring quality, consistency and compliance. “
The Certara Regulatory Sciences team has leveraged Synchrogenix Writer to deliver more than 10,000 patient stories, through technology-driven services for the life science industry. The team provided expert information during the product development process to ensure the software meets high quality standards and evolving global regulatory requirements.
For more information on Synchrogenix Writer, please visit https://www.certara.com/synchrogenix-writer.
Certara is accelerating drugs by using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its customers include more than 1,650 global biopharmaceutical companies, leading academic institutions and key regulators in 61 countries.
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