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Partnership simplifies digital data flows between Veeva RIM and Certara’s CoAuthor™ generative AI solution for regulatory and medical writing

RADNOR, PA– 2025 年 10 月 21 日 – Certara, Inc. (纳斯达克股票代码:CERT), a global leader in model-informed drug development, today announced it has joined the Veeva AI Partner Program. The planned integration by Certara with Veeva RIM aims to significantly enhance document automation by simplifying digital data flows between existing content stored in Veeva RIM and CoAuthor’s generative AI technology.

Rapidly changing study data often poses a significant roadblock for regulatory writers – from preparing first drafts to submission ready documents. This scenario costs the industry valuable time and creates tension between writers and the individuals in charge of preparing data for submission. In addition, the application of generative AI requires access to relevant data in near real time to provide acceptable results. Providing seamless access to content between data preparer, technology, and writer is critical to meeting shrinking submission deadlines.

By joining the Veeva AI Partner Program, Certara will allow its customers using CoAuthor and Veeva RIM to seamlessly work in both systems. Using CoAuthor, regulatory writers can directly link their source files from Veeva RIM, eliminating the need to import them into CoAuthor. This integration will streamline the initial content sourcing process, improving collaboration between data providers and regulatory writers throughout the document draft life cycle.

“Medical writers are embracing generative AI like CoAuthor to cut first-draft time by 30%. The integration with Veeva Rim allows us to deliver a seamless, end-to-end regulatory writing experience that drives greater value,” said Christopher Bouton, Chief Technology Officer at Certara.

To learn more, visit the CoAuthor webpage.

关于Certara

Certara 致力于通过生物模拟软件、技术和服务加速药物研发,改变传统的药物研发方式。其客户包括超 2,400 家生物制药公司、学术机构和来自 70 个国家的监管机构。了解更多信息,请访问 www.certara.com.cn。

Certara 联系人:

Sheila Rocchio
[email protected]

媒体联系人:

Alyssa Horowitz
[email protected]

利用人工智能解决方案简化法规撰写工作

Pharmaceutical regulatory writing can be overwhelming. Medical writers spend countless hours on compiling, reviewing, and formatting documents. Mistakes in this critical process can lead to significant delays in drug approvals, thus impacting patient care. The emergence of AI has brought new opportunities to streamline medical writing processes. However, implementing AI into regulatory writing requires an industry-specific approach beyond everyday AI applications’ basics. Certara is revolutionizing regulatory writing with an industry-specific GenAI solution. This white paper explores how your organization can deploy AI safely and securely to enable efficiency while ensuring accuracy

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常见问题解答

What is the Certara–Veeva partnership about?

This partnership integrates Certara’s CoAuthor™ generative AI solution with Veeva’s regulatory document management systems. It simplifies digital data flows, enabling regulatory writers to seamlessly access and use source files from Veeva Vault without manual imports.

How does this integration benefit regulatory writers?

Regulatory writers can now:

  • Quickly source and update content from Veeva Vault directly in CoAuthor.
  • Spend less time managing document transfers and more time focused on writing and analysis.
  • Collaborate more effectively with data providers to meet tight submission deadlines.

Why is this important for regulatory submissions?

Life sciences teams often face challenges with rapidly changing study data, which delays drafting and submission readiness. By providing near real-time data access and automated content integration, this collaboration accelerates document preparation, reduces friction, and helps bring therapies to patients faster.

Who can use the integrated solution?

The integration is available to organizations that use both Certara CoAuthor and Veeva Vault as part of their regulatory writing and submission processes.

What makes this partnership unique?

This collaboration combines Certara’s expertise in generative AI with Veeva’s robust data management capabilities. The result is a solution that not only automates document creation but also ensures accuracy and compliance by leveraging real-time data.

Where can I learn more about Certara CoAuthor and Veeva Vault?

Visit the Certara CoAuthor webpage for more details about CoAuthor. For information on Veeva Vault and its capabilities, explore the Veeva Vault Platform.

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