The first document writer built specifically for regulatory documents. We streamline the most time-consuming stages of setting up Investigator Brochures (IBs), Clinical Study Reports (CSRs), Clinical Study Protocols (CSPs), Informed Consent, Trial Disclosure Forms, and similar documents.
Start with templates based on ICH, GCP, and TransCelerate guidelines.View More
Easily add data graphs and tables to your regulatory documents.
Review your documents with writers, reviewers, and study experts.View More
Our software automatically builds an audit log of changes.View More
How it Works
Regulatory DocWriter™ features the necessary guidelines to ensure writers are within compliance when creating, reviewing, and submitting their documents to regulatory bodies. The platform works with you to provide the structure to create documents based on the regulatory templates, while providing you tools to ensure the content meets your specific needs.
No up-front costs, and a simple monthly subscription that pays off with increased productivity, collaboration, and compliance.
I love Otium Regulatory DocWriter™ because it saves me hours of time when setting up a new regulatory document, and incorporating feedback from reviewers is so easy!
Finally a writing tool that is designed for medical writing documents. I love the DocWriter™ system!
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