Pharmaceutical and Biotechnology

Pharmaceutical companies share a primary business goal of reducing time to market for new drug products. Unfortunately, the traditional processes and systems that most pharma companies use to create, store, revise, and manage content no longer serve this business goal.

Our pharma customers know that their traditional methods are holding them back. They cannot reduce time to market or increase the number of submissions without a serious transformation in how they “do” content. They need to break free of the document paradigm and adopt a structured content ecosystem.

That’s why they turn to Content Rules.

We have decades of experience guiding companies through the transformation to a structured content ecosystem that supports their business goals. We are the only end-to-end content services provider with experience in pharma.

Solutions

To produce content at scale, pharma companies need:

Content reuse
Automation

Pharma content has tremendous opportunity for content reuse and automation across the dossier and beyond. The only way to achieve reuse and automation at scale is by using structured content.

Download our white papers:

The Pharma Content Evolution: Content Reuse and Automation

The Five Dimensions of Content Standardization™ for Pharma

The CDS is Dead! Long Live the CDS!

Structured Content for Pharma: Making the Case for XML

Content reuse

Content reuse eliminates redundancy from your content and processes.

Automation

Automation eliminates time-consuming manual processes that increase risks and costs.

Why Content Rules

Content Rules is the only end-to-end content services provider with decades of experience in pharmaceutical content. In fact, our very first customer is one of the top five largest pharma companies in the world. We still work with them today.

Our services include content strategy, global content strategy, content transformation, content development, and content optimization. We are experts in structured content management, content standardization, and content governance.

We’ve helped numerous customers successfully complete their content transformation from unstructured documents to structured content ecosystems. We are the only content services provider with expert knowledge of Acrolinx, Congree, and Natural Language Processing (NLP) software.

Structured Content for Pharma

Pharmaceutical companies share a common goal to get drugs to market faster. To achieve this goal, they need to reduce the time it takes to create regulatory and associated content. Most pharma companies know that there is a better way to reduce the time spent creating and managing content.

Structured Content Authoring 101: Everything Pharma Needs To Know

The History Of Structured Content Authoring

Ever since people started sharing thoughts and information using the written word, the organization of content has been a principal consideration. This is because content organization is essential to ensure findability, comprehension, and overall communication.

Over the millennia, writers have grouped content in various ways. Sometimes content is grouped by theme or topic. Sometimes it is grouped sequentially, chronologically, or even alphabetically. When content is not grouped in some way, it can be impossible to find meaning. It could be said that content without structure is nothing more than random words on a page.

As young children in elementary school, we learn how to organize a simple essay: introduction, main body, conclusion. When we get a little older, we are taught about the structure of a novel: exposition, rising action, climax, falling action, denouement.

Some of us even structure our grocery shopping list. For example, produce, meat/chicken/fish, canned foods, dairy, and so on. Or we structure the list by what is in each aisle at our local supermarket. Structuring content comes very naturally to people.

In more modern days, writers often organize content in a hierarchy:

Books
Parts
Chapters
Heading 1
Heading 2
Heading 3
Bulleted list
Numbered lists

With this hierarchy comes rules and expectations. We expect everything in a numbered list to be sequential. We expect bullets in a list to relate to each other. Multiple heading 3s should all be related in some way, and should “roll up” into the larger heading 2. And so on.

Scientific writing often exposes the structure explicitly by using numbered headings. For example, the sections of a United States Prescribing Information (USPI) are mandated to include are:

Indications And Usage
Dosage And Administration
Dosage Forms And Strengths
Contraindications
Warnings And Precautions
Adverse Reactions
Drug Interactions
Use In Specific Populations
Drug Abused And Dependence
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
References
How Supplied/Storage And Handling
Patient Counseling Information

And so on.

Structure makes it easier for people to find the information they need. A consistent structure sets an expectation for what information goes first, second, third, and what the reader will find in each section.

What Is Structured Content Authoring?

Structured content authoring is the process of writing content using a defined organization. It codifies the concept of organizing content and makes content findable, accessible, interoperable and reusable (FAIR).

SCA is based on structured content. Structured content is content that is modular, consistent, and reusable. Structured content is:

Created as a set of building blocks of information (components)
Created and stored with minimal formatting
Tagged with metadata
Organized and stored in a centralized repository
Publishable to a variety of formats

To produce pharmaceutical documents, components are assembled into the required order and hierarchy. The assembly can be automated by a structured content management (SCM) system. Much of the document can be pre-populated with reused content, boilerplate text, pre-formatted tables, and data retrieved from other sources.

With structured content authoring, authors can use their time to create valuable content rather than copying and pasting, formatting a Word document, or manually moving components into place.

What Are The Differences Between Structured And Unstructured Content?

There are many differences between structured and unstructured content. Three main differences are:

How information is written, stored, and updated
Whether the information is written with or without formatting
Whether different copies of the content are needed for each type of final output

This table shows the differences between structured and unstructured content.

Structured Content	Unstructured Content
Information is written, stored, updated, and managed in small components.	Information is written, stored, updated, and managed in a single file.
A “document” contains one or more components that are assembled in a particular order.	A “document” is a single, monolithic piece of content that contains all of the information in a specific order.
Information is written and stored with minimal formatting. Formatting is applied when content is published. The same component can be used for different formats, devices, screen sizes, and so on.	Information is formatted as it is written. A different version of the information is required for different formats, devices, screen sizes, and so on.
Content can be reused from a single source of truth.	Content is reused by copy and paste, resulting in multiple versions of the same content.
Updates and changes made to the single component are reflected in all assemblies that use the component.	Updates and changes need to be made to every instance of the content. Redundant content increases the risk of content drift.
Data can flow automatically into a component.	Data is manually typed into a document.
Provides detailed traceability of every change made within a component, as well as changes made to the full document. Only the affected component must be versioned.	Provides traceability at the document level. A change to a single word necessitates a new version of the entire document.
Can send a single component or a subset of components to another system directly, without creating a full document or duplicating content.	Must create a separate file to send a subset of content to another system.
Supports omnichannel publishing from a single source of content.	Each delivery channel needs its own file or files.

What Are The Benefits Of Structured Content Authoring?

There are many differences between structured and unstructured content. Three main differences are:

How information is written, stored, and updated
Whether the information is written with or without formatting
Whether different copies of the content are needed for each type of final output

This table shows the differences between structured and unstructured content.

Structured content offers tremendous benefit to the business. The benefits of structured authoring include reduces risk, saves time, and produces higher quality content. Structured content costs less to create, manage, review, publish, and translate.

The benefits of structured content authoring are achieved by providing the following:

Reuse of a single content component
A single source of truth
Updates in one place to update all documents and outputs
Fewer documents to manage
Lower translation cost
Use the same content in different output formats

Who Creates Structured Content?

All authors in the company can create structured content. Structured content authoring streamlines development of all types of pharmaceutical documents.

The first adopters of structured content authoring within a pharma company may be technical writers in CMC, regulatory writers in global labeling, or medical writers in clinical. We also see SCA adoption starting in commercial or medical information teams.

How Do You Manage Structured Content?

Structured content is best managed with a combination of processes and technologies. The processes for managing structured content are developed and defined in your structured content strategy.

The technologies for managing structured content typically include the following systems:

Structured content management system (SCMS)
Structured content authoring (SCA) interface
Submission document management system (DMS)
Integrations between the SCMS and data sources

The SCMS provides content lifecycle management at a very granular level. You’ll manage content reuse, authoring templates, metadata, variables, and component workflows in the SCMS. The SCMS tracks all changes to content structures, content reuse, and the textual content itself.

The SCA interface provides authors and reviewers with a collaborative workspace. The authoring interface enables content creators to develop content in a familiar document-like environment. Behind the scenes, the SCA interface ensures that all content is created according to the defined structures.

The DMS provides document management capabilities such as assembling final documents into submissions. Final approvals for document and submission readiness is typically managed in the DMS.

Structured content makes it feasible to build integrations with data sources such as clinical data management systems (CDMS), laboratory information management systems (LIMS), and product quality systems (PQS). These integrations eliminate the need for authors to copy and paste data from one document to another. Instead, the data can be retrieved from a source of truth

What Is A Structured Content Strategy?

A structured content ecosystem starts with a structured content strategy.

A structured content strategy is a business plan for content. A structured content strategy defines the structures necessary to ensure that content is nimble, usable, reusable, findable, and relevant. It includes your information architecture, your governance model, and your business goals.

Without a strategy, the new processes and systems you implement to support structured content authoring will not be as successful. In fact, most of the failed attempts at adopting structured content in the past failed due to a lack of strategy, not a lack of technology.

A complete structured content strategy includes these elements:

Content Models	A set of rules that define what content to include, under what conditions, in what order.
Structured Authoring Guidelines	Provides authors with guidelines and examples to help them create reusable, modular content according to standards.
Reuse Strategy	Rules and guidelines that define which content to reuse where and which mechanism to use to accomplish the reuse.
Reuse Map	A specification for configuring automated content reuse.
Taxonomy	An organizational structure that ensures authors and systems can find components to retrieve or reuse.
Metadata	A controlled set of tags that identifies content so that machines canprocess it appropriately.
Workflow	Status and transition indicators that streamline processes and provide an audit trail for all content.
Governance	Rules and guidelines for how people interact with the content now and in the future.

What Are Structured Content Standards?

Content standards are the set of rules and guidelines that govern content. They help ensure a successful integration of people, processes, and systems.

Content standards include:

Words that are preferred and words that are not allowed
Style and grammar rules
Voice and tone (such as scientific paper or lay summary)
How sentences combine to create paragraphs (and where the data comes in)
How paragraphs combine to create sections or content components
How components combine to create the final output
Standards also define how content is written, stored, managed, published, and retired

Content standards enable you to make your content FAIR: findable, accessible, interoperable, and reusable.

What Are The Fair Principles Of Content Standardization?

When thinking about enforcing standards, it is nearly impossible to avoid talking about FAIR principles. FAIR is a set of guidance principles developed by data standards bodies. These standards ensure that data can be used and reused effectively and efficiently.

Like data, content must be FAIR so we can view, exchange, and manage it. With FAIR data and content, we can build automation, connect applications, and ensure a successful flow of data from a single source of truth to wherever that information is needed. Content standardization enables pharma companies to truly take advantage of the benefits of standardized content such as:

Automate content creation, revision, assembly, and delivery
Integrate data with content
Create more content, more quickly, with less overall risk

The Five Dimensions Of Content Standardization

Content Rules developed the Five Dimensions of Content Standardization framework using
knowledge gained over decades of helping companies transform to component-based structured
content. The Five Dimensions of Content Standardization framework is designed to treat content like data, ensuring that it is FAIR.

The Five Dimensions of Content Standardization are:

Output type
An output type is an assembly of content that is delivered as a complete unit. Some common output types in pharma include:
- Clinical Study Report
- SmPC
- PBRER
- Clinical trial summary on ClinicalTrials.gov
- P.8.2 Post-Approval Stability Protocol and Stability Commitment
Component
A component is an independent unity of content that can be combined with other components to create an output. Some common components in pharma include:
- Adverse Event
- Therapeutic Indication
- Mechanism of Action
- Stability Data
- Analysis Set
Paragraph
The paragraph is the central building block of content. Paragraph standards include criteria such as:
- Recommended maximum length
- Voice and tone guidelines
- Target reading level
- When to use lists or tables instead of paragraphs, particularly for integrating data into the content
- When to use notes
Sentence
Grammar and style rules govern how words and data are combined into sentences. Sentence standards are particularly important for ensuring that data flows logically into the content. Sentence standards include:
- Grammar
- Style
Word
A word is the smallest standardized content using. A collection of standardized words is called terminology. Terminology standards improve clarity. For example, in a clinical trial, a “patient” can mean something different than a “participate” or a “volunteer.”

The Five Dimensions of Content Standardization ensure that content can be reused everywhere it is needed, and that data and content can be integrated. When content is standardized across all five dimensions, processes from authoring to archiving can be automated, streamlined, and standardized. Content accuracy and quality increase. Risks are minimized.