Outsourcing in Clinical Trials East Coast 2025

サターラはライフサイエンス業界のイノベーターと連携することで、患者さんに医療を迅速に届けます。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.

• 275以上のeCTD準拠テンプレートにスタイルガイドを適用することで、文書のフォーマットに費やす時間を50%削減できます。
• 複合語から作用機序に関する段落まで、あらゆる文章をすべてのドキュメントで再利用できます。
• 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

• パンフレット：From Protocol to Submission: Essential Regulatory Writing Resources
• Schedule a CoAuthor Demo: 薬事規制文書のための生成AIとライティングソフトウェア
• Factsheet: CoAuthor | Factsheet

• Factsheet: 規制対応と薬事申請コンサルティング
• ブログ：Authoring & Assembling IND & CTA Applications – Insights & Updates
• White Paper: New EU Clinical Trial Regulation
• Factsheet: サターラ の戦略的早期開発ソリューション

• 論文: Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future
• 事例：テクノロジーを駆使したオーサリングで患者ナラティブに変革をもたらす
• White Paper: Avoid & Fix Common Errors in Regulatory Submissions for Drug Products
• ウェビナー：RAPS Sponsored Webcast: Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview | Certara

• ブログ：Categorizing & Managing Risks in Aggregate Safety Reports
• White Paper: DSURs, RMPs, and PSURs – The Harmonization of Pharmacovigilance Documents
• On-demand webinar: RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind
• ブログ：FAQs on Developing EMA Policy 0070 Submissions
• ブログ：How To Respond to Health Authority Questions