Fonto One for pharma

Structured content authoring and publishing for highly regulated content, in any language, with any LLM

Why Fonto One?

Electronic documents have been around for decades. As humans, we like them because they mimic printed materials, but they are very inefficient and poor input for AI-driven processes. It’s time to abandon tedious management of documents, and step into the era of structured content with

Fonto One

Our end-to-end online platform for securely managing structured content provides all the capabilities you need for managing document templates, AI-enabled authoring and review, translation, collaborative workflows and project management. All while solving the inefficiencies of traditional word-processing by using:

Content building blocks (components) instead of monolithic documents

Content reuse and automatic data ingestion instead of copy/paste duplication

Dynamic output for each use case (e.g., new layout or file type for same content)

Use cases

Clinical

Create and update even the most complex documents more efficiently across the clinical development cycle, with granular content reuse and other automations that minimize manual effort and error. From study protocols to manuals and clinical study reports, you’ll produce more consistent and accurate documents, significantly faster.

Regulatory

Simplify submission preparation with automated data ingestion, approved content reuse, precise version control, reliable audit trails and dynamic output from a single source –directly into your RIM system or to any other destination – all of which minimize risk and help you respond faster to regulatory change.

Manufacturing

Transform the creation of critical CMC documentation with sophisticated workflow controls that help stakeholders focus just on their piece of the puzzle in a timely manner. Also tailor to different local requirements, including translations, with the help of highly automated control of content variations.

Safety

Take the pain out of pharmacovigilance by easily generating PBRERs, RMPs and aggregate safety reports across the product lifecycle. Customized templates help you fulfil the needs of each document type (e.g., PSUR, DSUR), while the principles of structured content minimize errors and accelerate authoring, review and approval.

Key benefits of Fonto One

Generate first drafts faster with AI

Shrink authoring time by using pre-approved content and leveraging the large language model (LLM) of your choice to generate a first draft for narrative text chunks. With these two approaches you can significantly slash authoring, review and approval times.

Collaborate more easily

Improve quality and streamline processes by allowing authors, reviewers and SMEs to work collaboratively in real-time in an intuitive Word-like tool. Any number of users can work on the same document, no matter how complex or lengthy, and use comment threads to exchange feedback.

Improve content consistency and variation control

Enable editors to reuse pre-approved content components, so they never waste time again rewriting existing content for different variations of a document. With Fonto One, it’s easy for editors to see when content or data changes, so they can decide whether or not to propagate it automatically through all applicable documents.

Translate faster and cheaper

Fonto One, combined with the RWS translation management system (TMS) Trados Enterprise, supports efficient translation by tracking the relationships between source and target language components. Reviewed and approved content components are pushed to the TMS, translated using the desired translation method, then sent back to Fonto One.

Save time and effort with automated output

From a single working document, you can generate different types of output (such as Word, PDF, XML, JSON, FHIR), and apply various output templates to produce specific document layouts and designs. You can also push files to connected systems such as your RIM system, or give applications such as AI-powered services access to your structured content.

Comply with a smile

Reduce risk and simplify compliance with vastly improved content consistency, dependable translations, precise version control and reliable audit trails that track all changes in each content component, working document and output file.

How Fonto One works for users

Working in Fonto One is based on the following principles:

Templates prescribe what needs to be authored and where to ingest data. They are built from reusable components and smart fields

Jumpstart your work with powerful templates

Easily build a library of templates, starting from scratch with new components or reusing ones previously created. Add smart fields (placeholders) where you want data from connected sources to flow into tables, charts or text areas as a working document is instantiated.

Working documents encourage a focus on content accuracy and completeness. They reuse data, guide the writing of new content, and simplify authoring and review

Use automation and AI to be more efficient

Create a working document from a template, auto-populated with components and with data. Deliver first drafts much faster with content reuse, guidance for authors and AI writing assistance, and accelerate document completion with advanced workflows, controls and permissions for commenting on, editing, approving and translating content.

Once a document is approved, it can be used to generate multiple forms of output: different layouts, designs and file types (e.g., PDF, Word, XML, JSON, FHIR)

Publish dynamic output anywhere

Easily preview and generate document outputs based on the layouts, styles and file formats you need. You can also easily transfer content to any other connected system for further processing, storage and delivery.

Fonto One solution architecture

Dashboard

The Fonto One dashboard shows users their assigned tasks, due dates, workflow states and other information to help them manage their work effectively, from building templates to authoring and finalizing working documents.

Data ingestion

This capability of Fonto One enables you to pull data from external data sources such as a data warehouse or data lake. It enables data-driven content authoring, automatically populating tables, charts and more with the right information.

Structured content authoring (SCA)

The Fonto One SCA module comprises the Fonto Editor, Fonto Review, Fonto Content Quality and Fonto Document History modules, which together allow authors and SMEs to work collaboratively in a familiar Word-like interface and reuse content to save time and reduce errors, while employing GenAI tools to speed up work.

Localization

Fonto One integrates seamlessly with RWS Trados Enterprise translation management technology. The translation process can be initiated by an author and the integration streamlines it like never before. The CCMS manages the ongoing relationships between source and target language components, to ensure ongoing consistency when updates are made to the source.

Output

The Output module turns working documents into the output format of the user’s choice (dynamic output). Users can preview documents in their final form before exporting them for publication or submission. The flexible Fonto One API can be used to connect to target systems that need direct, programmatic access to content.

Component content management system (CCMS)

At the heart of Fonto One, the CCMS securely stores and manages all templates, components, outputs, associated metadata, language versions and underlying data structures. The CCMS also manages all the relationships between these objects and provides a flexible API to support integration.

Click on the elements below to discover more.

Features summary

Robust CCMS

Replace monolithic documents with component content management

User-friendly SCA

Simplify structured content authoring with a Word-like interface

Workflows and dashboard

Configure the system to work the way you need

Audit trail

Achieve 100% accurate change history at component level

Data-driven documents

Assemble documents tailored to different external data conditions

Data ingestion

Include/reference data from approved sources without copy-paste

Content reuse

Resuse content (as-is and derivative) without duplication

Word / PDF / XML / FHIR

Generate submission-ready documents in the required output format

In-browser preview

See what documents will look like before finalizing them

Integration

Publish directly to Veeva, Documentum and similar systems

Cloud hosting

Choose between public and private cloud deployment

Security

Have full control of user permissions and content access

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