The Company Core Data Sheet (CDS or CCDS) is one of the most important documents a pharmaceutical company creates. The CDS is a working document that contains information about the pharmaceutical product. It includes information from multiple sources, such as clinical trial data systems, clinical report documents, CMC data systems, CMC reports, and information stored in RIM and other systems. The CDS acts as a repository for reference information such as:
- Dosing requirements
- Methods of administration
- Indications
- Packaging and storage requirements
- Incompatibilities
- Pharmacological properties
The CDS is an internal document that is never published on its own. However, it contains content that is used in other documents, including:
- SmPC
- USPI
- PIL
- Medications Guide
- Regional labels for global markets
- Packaging
A lot of critical information goes into the CDS, and a lot of critical information is created from the CDS.
Why, then, are most pharma companies using a legacy, inefficient, and error-prone method of creating and managing the CDS?
I have asked myself this question dozens of times.
The CDS is almost always a Microsoft Word document. Over time, authors continue to add content to the CDS. They also copy and paste content from the CDS to other documents.
In this way, the CDS is treated as a repository, storing critical information in one location. Unfortunately, a Word document is not suited to be a repository. Word lacks necessary features that are basic to a content repository, such as content reuse, version control, and single-source publishing to multiple formats.
Why Word Doesn’t Work
There are many reasons why Word (or any word processor) is the wrong tool for the CDS. First and foremost is the mechanism by which we create Word documents.
Word is a document authoring tool that has a great feature set for a single writer creating a single document. Even though recent versions of Microsoft 365 allow for multiple authors, a Word document is still just a document.
To create the CDS, authors copy and paste content from source documents into the CDS Word file. As soon as this happens, there are two versions of the information: one in the source document and the second in the CDS.
As time goes on, iterations happen. Information is altered, corrected, and updated. Changes are made. Keeping all of the documents that contain the information in sync is a manual, and often overlooked, task. If even one change fails to be back-propagated, the information bifurcates and the copies are no longer identical.
When a document is created from the CDS, the same thing happens. Content is copied and pasted into the new document. Now, we have at least three versions of the very same content:
- The source content that is used to create the CDS
- The CDS
- The destination content that is created from the CDS
If changes are made to the SmPC or USPI, those changes might also need to be made to the CDS. In fact, the change might need to be propagated across multiple internal documents and throughout the dossier.
As time goes on, iterations continue. Information is altered, corrected, and updated. Changes are made. Keeping all these documents in sync is a manual task.
The more changes that are made, the more out of sync the information becomes.
A Better Solution
Rather than using a Word document as a repository, a much better solution is to use an actual repository in the form of a component structured content management (SCM) system.
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
Rather than creating documents, content is written in small chunks of information called components. A component is a piece of information that describes a single topic or idea. For example, therapeutic indications or methods of administration are components.
Each component is written, stored, and managed one time. If there is a change, it occurs once, in the only instance of the component.
To produce documents, components are assembled into the required order and hierarchy. You can choose to automate document assembly, assemble components manually, or combine automation and manual efforts.
Let’s take global labeling documents as an example. Regional labels provide much of the same information as the USPI and the SmPC. These labeling documents can be pre-populated from the CDS with reused content, boilerplate text, pre-formatted tables, and data retrieved from other sources. Authors can then add the unique content as required for the region or type of document.
Using structured content, content is created and data is integrated without a lot of formatting. Instead of authors assigning heading styles and manually creating every table, the system provides document formatting and layout based on your stylesheets and output templates. You can output the document to just about any file format you need, from PDF or Word to XML or Adobe InDesign.
Authors and SMEs can use their time to create valuable content rather than copying and pasting, formatting a Word document, or manually moving components into place.
Do We Still Need the CDS?
A case could be made that when you use an SCM and component-based content, the need for the CDS is eliminated. After all, the CDS is never published. It is simply a holding tank for pieces of information.
If you use a true repository to store those pieces of information, the need for the CDS as a document largely goes away. You can instead maintain a repository of components and use those components everywhere the information is needed.
That said, you can still publish a CDS if you need one. All you need to do is select all of the components you want, in the order you want them. Then publish your CDS to whatever output format you need.
Using an SCM and component-based content provides the most flexibility and security for the least amount of time and effort.
Content Rules, Inc. is one of the oldest and most established content strategy firms in the industry. Our content transformation methodology has been proven in life sciences over the past 20 years. Our content strategists are experienced with the unique challenges of pharma content, as well as the common content challenges that all enterprises face. Contact us to learn more about how we can help you solve your content challenges.
Val is on the Advisory Board for the Technical Communications Program at the University of North Texas. When not working with customers or students, Val can be found sitting behind her sewing machine working on her latest quilt. She also makes a mean hummus.
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