Certara Launches New Synchrogenix™ Writer Software to Accelerate the Regulatory Submission Process

Rhea-AI Summary

Certara has launched Synchrogenix Writer, a cloud-based regulatory SaaS product aimed at automating and improving the quality of patient narratives critical for clinical study reporting. This innovative solution addresses the inefficiencies of the traditional manual writing process, which is costly and time-consuming. By enabling data-mapping and early drafting, the software ensures consistency, reduces risk, and accelerates the time to regulatory filing. With over 10,000 patient narratives already delivered, Synchrogenix Writer is positioned to meet evolving global regulatory requirements.

Positive

• Launch of Synchrogenix Writer, enhancing efficiency in patient narrative creation.
• Automation of patient narratives addresses time and cost inefficiencies.
• Potential for quicker regulatory filing due to advanced drafting capabilities.
• High demand indicated by delivery of over 10,000 patient narratives.

Negative

• None.

Cloud-based and validated regulatory software automates and advances quality of patient narratives

PRINCETON, N.J., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Certara, a global leader in biosimulation, today announced the launch of Synchrogenix™ Writer, a new regulatory SaaS product that expedites the authoring and review of patient narratives. Patient narratives describe adverse events or adverse drug reactions and are critical to clinical study reporting across every therapeutic area throughout the clinical phases.

“In today's automated and standards driven clinical and regulatory processes, authoring patient narratives remains primarily a manual process,” said Daniel R. Matlis, Founder and President of Axendia, a leading life science industry analyst firm. “As the number of clinical trials increases globally, this approach is not sustainable. The availability of a product like Synchrogenix Writer provides life science organizations a solution to help automate the writing process, shortening the time to regulatory filing.”

The traditional, manual narrative writing process is time consuming and costly due to integration of information from various sources, large authoring teams, and multiple rounds of drafts and reviews. Spearheaded by Certara’s regulatory writing experts, Synchrogenix Writer software automates data-mapping and enables earlier drafting before database lock, resulting in increased consistency, reduced risk and expedited time to regulatory filing.   

“Managing patient narrative projects with tight timelines is challenging, especially given the complexities that go into preparing important clinical documents to meet regulatory requirements,” said Leif E. Pedersen, President of Software at Certara. “With Synchrogenix Writer, organizations can manage thousands of patient narratives in a fraction of the time while ensuring quality, consistency and compliance.”

Certara’s Regulatory Science team has leveraged Synchrogenix Writer to deliver more than 10,000 patient narratives, through technology-driven services for the life science industry. The team provided expert insight during the product development process to ensure that 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.

About Certara

Certara accelerates medicines using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.

Certara Contact:
Jieun W. Choe
jieun.choe@certara.com

Media Contact:
Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com

Investor Relations Contact:
David Deuchler
Gilmartin Group
ir@certara.com

FAQ

What is Synchrogenix Writer and how does it benefit Certara?

Synchrogenix Writer is a regulatory SaaS product launched by Certara that automates the authoring and review of patient narratives, improving efficiency and reducing costs.

How many patient narratives has Certara delivered using Synchrogenix Writer?

Certara has delivered over 10,000 patient narratives using Synchrogenix Writer.

What challenges does Synchrogenix Writer address in clinical trials?

Synchrogenix Writer addresses the inefficiencies of the traditional manual narrative writing process, aiding in faster regulatory filing.

What are the primary features of Synchrogenix Writer?

Key features include automation of data-mapping, enabling early drafting before database lock, ensuring quality and consistency.

When was Synchrogenix Writer launched?

Synchrogenix Writer was launched on September 30, 2021.