Outsourcing in Clinical Trials East Coast 2025

At Certara, we accelerate medicines to patients, partnering with life science innovators. 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.

• Spend 50% less time formatting your document by applying your style guides to more than 275 eCTD compliant templates.
• Reuse any portion of your writing, from a compound name to complete paragraphs on mechanism of action, across all your documents.
• 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: Life Science Specialized GenAI for Regulatory Writing
• Factsheet: CoAuthor | Factsheet

• Factsheet: Regulatory Consulting and Regulatory Affairs
• Blog: Authoring & Assembling IND & CTA Applications – Insights & Updates
• White Paper: New EU Clinical Trial Regulation
• Factsheet: Certara Strategic Early Development Solutions

• Publication: Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future
• Case Study: Changing the Narrative on Narratives Using Technology-Enabled Authoring
• White Paper: Avoid & Fix Common Errors in Regulatory Submissions for Drug Products 
• Webinar: RAPS Sponsored Webcast: Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview | Certara

• Blog: 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
• Blog: FAQs on Developing EMA Policy 0070 Submissions
• Blog: How To Respond to Health Authority Questions