###### ICH DOCUMENT TEMPLATES

# 450+ Pre-Formatted ICH Templates

Kickstart authoring with pre-formatted ICH Document and Protocol Templates at your fingertips - fully integrated with your DMS workflow.

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## Pre-Formatted ICH Clinical Protocol Templates for Regulatory Agencies

##### Always Up-to-Date Templates for ICH Compliance and Efficiency

Using templates is a great way to not only improve structure and consistency - but also speed up document authoring. That’s why we built Kivo’s ICH Templates directly into MS Word - with guidance references, placeholder content, and complete customization options.

###### ICH DOCUMENT TEMPLATES

## Streamline Clinical Trial Protocols with Kivo’s ICH Document Templates

We’ve taken care to implement 450+ ICH templates in our MS Word authoring and DMS in ways that speed up authoring and improve consistency across your teams. We've designed our documents without macros, so you don't need to worry about local installs or technical issues, whether your team is on Macs or PCs.

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#### Benefits of using Kivo’s ICH Document Templates:

##### Templates for Multiple Agencies

Our package includes templates for the FDA, Health Canada, EU M1 and IMPD, Clinical templates following M11, and additional non-clinical templates.

##### No Installation Required

With Native MS Word implementation, no macros and no ‘master template’, everyone can use Kivo templates with no installation needed.

##### PDF-Ready Styles

Designed to be saved as PDF, our templates properly generate TOCs and convert to PDF without any hiccups.

##### Customization Options

Save your own edits, such as M3 heading style customization (3.2.A.1 vs. 1), custom Company and Product names and flexible header/footer alignment - or upload your own entirely.

##### Smart Instructional Text

Clear instructions are included with every template. Toggle on and off while authoring, and remove the instructions if/when you are ready.

##### Built-in Content Guidance

Built in Guidance includes reference text, placeholder content, and shell content (tables, list of abbreviations, confidentiality statements, etc.)

## Accelerate Your Workflow with Kivo

See how Kivo can help your team reduce manual work and improve compliance.

## Kivo FAQs

### What is an ICH protocol template, and why is it important?

An ICH protocol template ensures standardized formatting and content structure for clinical trial documentation, helping meet ICH compliance for a variety of submission types and agencies. Kivo's templates support medical device, pharmaceutical, biologic, and combination product submissions.

### Can Kivo's ICH templates be customized?

Yes, Kivo templates are fully customizable. Tailor templates with headings, product names, or even upload your own.

### Do I need to install special software to use Kivo’s templates?

No, Kivo’s templates integrate directly with MS Word without requiring macros or additional installations, ensuring seamless functionality across devices.

### How do Kivo’s ICH templates support ICH compliance?

Kivo templates include built-in content guidance, instructional text, and standardized formats that align with ICH guidelines and other regulatory requirements. Templates are updated regularly.

### Are Kivo’s templates compatible with both Mac and PC?

Yes, Kivo’s ICH protocol templates are fully compatible with both Mac and PC, making them accessible for all team members.

### What does Kivo cost?

We pride ourselves on our affordability - [visit our pricing page](/content/pricing/index.html) to learn more!