Using AI to gain efficiencies for medical writers
PRINCETON, N. J.— October 3, 2023— Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation software and advanced drug development solutions, today announced the launch of CoAuthor, a writing software suite designed to revolutionize the creation and review of critical clinical trial documents in the pharmaceutical industry.
CoAuthor, previously branded as Synchrogenix Writer, incorporates the latest technologies for medical writing all within one turnkey solution. With recent advancements in generative AI and structured content authoring, medical and regulatory writers are looking for industry specific solutions that can be implemented today to accelerate drug development timelines. By utilizing a solution like CoAuthor, submission teams have reduced document development timelines in excess of 20%, giving them a key advantage while simultaneously improving consistency.
“Generative AI is accelerating digital transformation across Regulatory Affairs and writing,” said Max Kanevsky, Chief Technology Officer at Certara. “CoAuthor is designed for regulatory teams looking to modernize and accelerate their productivity with a platform approach that automates end to end workflow.”
CoAuthor Features for an Optimal Writing Experience:
Built with the feedback of Certara’s premiere team of regulatory writing and scientific communication experts, CoAuthor is the most expansive system built to date that aids medical writers with capabilities such as:
- Extensive Clinical Document Support: Efficiently accelerate development of clinical trial documents such as Protocols, Synopsis, Clinical Study Reports (CSRs), Patient Narratives, and more, in one turnkey system.
- Data Integration: Directly incorporate analysis datasets, CDISC data, tables, listings, and figures within a report, providing a real-time preview. With the ability to refresh results at any point, teams work in advance to reduce cycle times.
- Digital Data Flow: Define study-level information and metadata that flows into and across documents, promoting consistency and saving time through content reuse.
- Auto-Generated Content: Writers can select eTemplates from the library that auto-populates content, headings, styles, etc. to streamline the writing process and automate time-consuming tasks. Assistance in crafting messaging and concluding results is further aided by the Certara.AI generative AI plugin.
Proven Results
Using many of the advanced capabilities included in CoAuthor, Certara experts have completed 300 regulatory submissions and authored over 24,000 clinical documents.
To learn more about all the features of CoAuthor, click here.
About Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.