Outsourcing in Clinical Trials East Coast 2025

在 Certara，我们携手生命科学领域的创新者，以更快地向患者提供药物。Together we advance modern drug development with biosimulation, regulatory science, and market access solutions. We use software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

Regulatory writing technology needs to be smarter, user-friendly, and collaborative—and CoAuthor delivers. It streamlines the process with fast template selection, structured content authoring, and generative AI within Microsoft Word.

• 通过应用样式指南到超过 275 个符合 eCTD 标准的模板，可节省 50% 的文档格式设置时间。
• 在您的所有文档中，都可以重复使用您写作中的任何部分，从化合物的名称到关于作用机制的完整段落。
• Leverage a biomedically-specialized GPT behind your firewall, for secure, prompt-based text generation

GlobalSubmit enables teams to manage the regulatory process so they can successfully publish, validate, and review eCTD submissions across a global footprint of regulatory health authorities.

• Create submissions that conform to any or all of 9 health authorities’ required structure, XML, and validation report.
• Review eCTD submissions across stakeholders prior to submitting

• Brochure: From Protocol to Submission: Essential Regulatory Writing Resources
• Schedule a CoAuthor Demo: 针对法规撰写的生命科学专业通用人工智能
• Factsheet: CoAuthor | Factsheet

• Factsheet: 申报审批咨询及相关事务
• 博客：Authoring & Assembling IND & CTA Applications – Insights & Updates
• White Paper: New EU Clinical Trial Regulation
• Factsheet: Certara 战略早期开发解决方案

• Publication: Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future
• 案例研究：使用技术辅助创作功能，改变有关叙事的叙述
• White Paper: Avoid & Fix Common Errors in Regulatory Submissions for Drug Products
• 网络研讨会：RAPS Sponsored Webcast: Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview | Certara

• 博客：在汇总安全报告中分类和管理风险
• White Paper: DSUR、RMP 和 PSUR — 统一药物警戒文件
• 网络研讨会点播：RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind
• 博客：制定 EMA 政策0070 提交材料的常见问题解答
• 博客：How To Respond to Health Authority Questions