According to The University of Texas at Austin, pharmaceutical companies lose an average of $1 Million per day when drug approvals are delayed. Several factors can contribute to approval delays. Some of these factors relate directly to content.

Compared to other industries, it takes pharma companies about five times longer than it should to create content. Many factors contribute to the increased time it takes for these companies to create their content including:

  • The submission or application is delayed
  • The submitted content is incomplete or inaccurate
  • The submitted content is difficult to read, forcing health authorities to work harder and go slower to decipher it
  • The submitted content is locked in long documents and any change triggers a new review of the entire document
  • Content is not standardized beyond the minimum requirements to comply with the eCTD tree

The tools are behind

The truth is, the content ecosystem used by most pharma companies does not support their business objective: to get safe drugs to market faster. The tools used to support, create, and manage submission content are outdated, inadequate and hampered by legacy processes and traditions. The result is a vast amount of content — much of it redundant — locked in monolithic documents where it is hard to find, hard to update, and hard to use.

While each tool has its optimal usage depending on the function and purpose, these tools do not solve the industry’s unique content challenges:

  • Microsoft Word to create documents
  • A document control system such as Sharepoint or Documentum
  • A Regulatory Information Management (RIM) system used to consolidate, format, and submit documents to health authorities and regulators
  • Systems to publish physical labels and packaging
  • Files in many formats (including documents, spreadsheets, and presentations) to exchange information with internal and external partners, CROs, sites, and regulators

The ecosystem can’t support the process

In addition to old tools, the processes used to create and manage the content are complex and cumbersome.

Here’s a simplified view of a typical workflow for a clinical summary report provided in Module 2 of the eCTD:

  1. Medical writer copies content from an existing Word document into a new Word document.
  2. Writer makes additions, deletions, and changes for new document.
  3. Data is copied from various sources and pasted into the document.
  4. Content is copied and pasted into additional documents, often with minor tweaks such as verb tense or punctuation.
  5. Writers and reviewers revise content, including all the redundant content created through copy, paste, and tweak.

Even if only one section of the document needs review, the entire document must be checked out and opened. Writers and reviewers may get distracted by content in other sections. It may take several iterations before they can complete their reviews, especially when discrepancies or inconsistencies in the redundant content require someone to find and update the information in several documents.

The result is multiple variations of the same information, spread across dozens or hundreds of documents. The risk of inaccurate information making it into a submission and being sent back by regulators is high, wasting time and costing money.

The inefficiency of manually creating the same information multiple times during the content lifecycle results in lower quality and more expensive content that is fraught with risk.

Insufficient methods are the risk

Take the company Core Data Sheet (CDS) for example. The CDS includes information from multiple sources. These sources may include clinical trial data systems, clinical report documents, CMC data systems, CMC reports, and other product information stored in RIM and other systems. The CDS acts as a repository for reference information though 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

Many companies maintain their core data sheets in Microsoft Word files. Writers copy and paste content from source documents into the CDS creating two versions of the information: one in the source document and the second in the CDS.

When labeling teams create the SmPC, USPI, and other documents based on information stored in the CDS, the same thing happens. Authors copy and paste content into their new documents.

  • The content used to create the CDS
  • The CDS
  • The content created from the CDS

If changes are made to the SmPC or USPI, those changes might also need to be made to the CDS. One change might need to be propagated across multiple internal documents and throughout the dossier. As time goes on, iterations happen. Information is altered, corrected, and updated. Changes are made. The more changes that are made, the more out of sync the information becomes.

Content Reuse is the Solution

Content reuse ensures that there are no discrepancies in the data and no mixed messages when one document needs to convey the same information as another document.

With content reuse, there is no copy and paste. You write and store the content one time. Then you use that one version everywhere you need it. To read about how content reuse reduces risk, download the eBook Structured Content for Pharma: Making the Case for XML.

Pharma deserves better. Legacy tools and processes no longer support the business objectives. The only way to meet the growing demands for more content, faster, is to adopt a structured content ecosystem and Content Rules can help.

Content Rules is the only end-to-end service provider with experience in pharmaceutical content. We have helped numerous companies transform from document-based publishing to component-based, structured content management. We developed our Five Dimensions of Content Standardization FrameworkTM to help pharmaceutical companies standardize content in all five dimensions to ensure that content is FAIR: findable, accessible, interoperable, and reusable. We can help you solve your complex content challenges. Contact us to see how we can help you!

Val Swisher
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