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@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Bridging Pharma Content Silos: Managing Content From Clinical Through Labeling and Marketing
Ann Rockley, CEO, The Rockley Group
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
The Rockley Group
More than 15 years’ experience in Healthcare
Clinical
Labeling
Promotional
Industry experts
Structured content strategy
Content reuse
Structured content management systems
Content globalization strategy
Multichannel delivery
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Rockley customers
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Ann Rockley
Known as the “mother of content strategy”
Forefront of content strategy, reuse, structured content management, multichannel delivery (print, Web, eBook, mobile)
Passionately committed to defining and sharing industry best practices
Master of Information Science
Fellow of the Society for Technical Communication
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Disclaimer
This presentation is not a recommendation for your pharmaceutical content, only your regulatory group and other authorized personnel can specifically identify your requirements.
This presentation is designed to provide an understanding of how you can more effectively create and manage your content
The list of documents is a partial list and not intended to be all inclusive
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Produce more than just pharmaceuticals
• Produce content… and lots of it!
As molecules are discovered and formulated into deliverable forms
As compounds/products are tested for safety and efficacy
As applications for regulatory review and approval are created
As labeling is developed
As marketing, sales and training materials are created for approved products
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Many types of documents
Investigational New Drug Applications (eIND)
New Drug Applications (NDA)
Clinical Study Protocols
Clinical Study Reports
Common Technical Document (eCTD)
Formulary Dossier
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Documents (cont.)
Core Data Sheet
United States Package Insert (USPI)
Medication Guide
Summary of Product Characteristics (SmPC)
Patient Information Leaflet (PIL)
Carton and package/container label
Medical letters
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Documents (cont.)
“Fair Balance Statement”
Preparation and administration/Dosage and administration
Sell Sheets
Reimbursement guides
Presentations
Training
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
In many areas
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
From the CSR we can use:
Clinical trial summaries
Charts/tables
Dosages
Adverse reactions
Etc.
Into
CDS
Presentations
Medical letters
Etc.
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
From the PI we can use:
Indications
Contraindications
Adverse reactions
Warnings and precautions
Storage and handling
Into
Fair Balance Statement
Dosage and Administration
Training
Medical letters
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Common content
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Share content
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Issues
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Issues
Content is stored in monolithic documents in multiple systems
The content is created, recreated and recreated over and over again for multiple documents
Content is copied and pasted, or copied and pasted and rewritten
Changes aren’t reflected across documents
The further the content gets from clinical, the greater the level of variation
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Manufacture our contentlike we manufacture our product
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Manufacturing consists of
Product Content
Component parts/ingredients Content components (text, graphics, tables)
Assembled in a defined way Consistently structured content and documents
Using repeatable processes
For a consistent outcome
With consistent quality Content is the same wherever it appears
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Good Manufacturing Processes
Product Content
Processes are clearly defined and controlled
Rigorous workflow
Any changes are evaluated Content that is reused is locked; changes must be approved. Not all documents will use/reuse the changed component(s).
Complete history of a batch can be traced Every component is versioned. A complete audit trail of changes/reviews/approvals is available.
Complaints and quality defects are investigated
Issues with content can be reviewed. Changes in one can be automatically reflected in all.
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Following content through documents
Content is often written a specific way for inclusion in a specific document. The content may not always apply in subsequent documents:
Too long/short
Different focus
Different Health Authority requirement
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Content can be identical
Refined
Package Insert
Fair Balance Statement
Standardized content
Statements
Regulatory content
Corporate information
Presentations/training
Refined content reformatted for display
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Identical vs. derivative
Identically reuse content where possible While identical content in all outputs is desirable it isn’t always
possible due to Health Authority feedback, different document purposes
Derivatively reuse content when necessary Content is reused then a variation on the source is created
(derivative) A relationship exists between source and derivative, when the
source changes the creator/owner of the derivative is notified of the change
The creator/owner can choose to incorporate the changes or not Complete audit trail of changes and derivatives Authors can only reuse source not derivatives unless the derivative
is promoted to alternate source (e.g., common regions)
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Assess variations (derivatives)
When authors write in isolation content varies
When authors work together, common content that does not compromise the quality or the message of the content can be created more often than you think
When a derivative is necessary, create the derivative then reuse it as much as possible
Fair Balance Statement
Presentation versions of content
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Where/how to start
Pick a content area:
Clinical
Labeling
Promotional
Create good content processes
Create consistently structured and written reusable components
Define standardized document structures
Manage the content through rigorous workflow
Manage change
When the first area is under control expand control into another area, merging content sources into a unified whole over time
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Summary
Pharmaceutical organizations:
Create massive amounts of content in multiple areas and stored in multiple systems
Content is recreated and recreated, or copied and pasted into diverging content streams
Manufacture content like you do product
Consistently written and structured content for reuse
Rigorously controlled for quality and consistency
Choose an area to control first then select another area to incorporate based on content that is reused from area to area
@arockley www.rockley.com ©2015 The Rockley Group, Inc.
Additional resources
Whitepaper: Challenges in Creating, Managing, and Delivering Pharmaceutical Content ([email protected])
Whitepaper: Addressing the Challenges of Pharmaceutical Content (coming soon, [email protected])
Book: Managing Enterprise Content: A Unified Content Strategy (Amazon, Barnes & Noble)
You can watch this webinar with Ann Rockley on the BrightTalk Channel at:
https://www.brighttalk.com/webcast/9273/146095