Meet the New Protocol Builder The only protocol writing software with a built-in AI Assistant*
Create a structured protocol writing environment to make the process of writing, collaborating and reviewing more efficient.
*Premium feature; setup required



Solutions for different organization types
- Solutions for Institutions, Biotech/Pharma and GME Programs
- Customize and configure software to your process needs
- Enterprise-strength cloud-hosted platform
New AI Assistant and other time-saving writing tools
- AI Assistant built into writing experience with familiar format
- Auto populate sample text for entire protocol
- Generate Informed Consent Form draft from protocol and consent form template
- New document dashboard with foldering and search capabilities


A structured environment to write protocols more efficiently
- Guided experience keeps investigators on track
- Built-in compliance at every step
- 16 protocol templates included (NIH and more)
- Template cohesion produces more predictable, compliant protocols
Reduce review delays with higher completion rates and compliance quality
- Progress dashboard reduces submission of incomplete protocols
- Tool tips guidance and sample text drives compliant writing
- Export options to fit IRB needs: Word or PDF, clean copy or with tracked changes
- Eliminate delays due version control issues


Automate Time-Consuming Tasks
- Sample Text: insert sample text by section or for entire protocols
- References Section: automatically numbers and orders references
- List of Table, Charts, Abbreviations and Glossary: automatically
- Consistent, professional formatting—no extra re-formatting effort
Collaborate seamlessly and eliminate version control issues
- Eliminate version control challenges with clear versioning
- Real-time alerts and notifications
- Select collaborators and access permissions
- “Needs Review” worklist highlights sections with changes


Informed Consent Builder – now with automatic draft generation
- Easier way to build, manage and generate compliant informed consent forms
- Instantly build consent form draft using protocol and informed consent form template language
- Built-in AI Assistant rewrites in 2nd person at 8th-grade level
Onboarding and on-going user support
- New user trainings and on demand one-on-one training
- Help Center with online tutorials
- Help Desk for users and administrators


Admin Control for Compliance and Customization
- Single sign-on setup
- Customize protocol and consent templates
- Tailor guidance, required text, and sample content
- User permissions and custom help center support
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Testimonials
“Our investigators really appreciate the step-by-step guidance, the collaboration tools and the protocol completeness dashboard features. Our goal is to use Protocol Builder as our protocol writing hub to enhance quality, reduce review time, and improve adherence to federal and IRB regulations.”
Clinical Research Navigator Clinical and Translational Science Institute
“Protocol Builder has helped us create a robust research infrastructure for our residency program. The collaborative features have increased research participation while significantly reducing the time spent in the protocol development phase. Protocol Builder offers guidance in protocol development that has allowed us to exceed our scholarly activity goals, and I strongly recommend it for any GME program.”