Presentation to the American Medical Writers Association, which asks: Why create a document collaboration maturity model? Whether your document collaboration processes meet your requirements?

1. Realize the power of document
collaboration
and ease the pain of medical writing
Dave Cornwell
CEO, PleaseTech
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2. Agenda
• Introduction
• Current processes
• The document collaboration maturity model
• Case study
• Technology options
• Further information
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3. The reality
• Creating the many complex documents required for clinical
trials, QA and regulatory submissions involves significant
editing and review
5+ participants and frequently many more
• An extreme (known and recent) example:
1 review had just under 140 documents
1 review had over 60 participants
1 review had over 3000 comments
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4. The reality (contd.)
• Requires secure collaboration with others both within and
outside the organization
• This collaboration is not easily achieved
Work around inflexible in-house systems
Geographically diverse teams
Working with external parties
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5. Current processes
Each has its own drawbacks:
email attachments
(Word, PDF)
review meetings
PDF mark up
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SharePoint
generic online tools
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6. Resulting in…
Email chaos
Lack of control
Multiple reviewed copies
Comment and change
consolidation issues
Meeting frustration
Frayed tempers
Wasted time
Missed deadlines
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7. Current processes
• For some: sufficient for requirements
e.g. few collaborators;
simple, short content
• For others: inefficient,
unsatisfactory and expensive
e.g. multiple reviewers, complex/large documents,
deadlines, content/layout must meet regulatory and
compliance standards
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8. The model
Q. Why create a document collaboration maturity model?
A. To ascertain whether your processes meet your
requirements.
Technologies exist that enable controlled
document collaboration – have your processes
kept up with the times?
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9. The model
• “Collaboration is implicitly assumed, without regard to
how it’s achieved”
• User expectations are often low
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10. Methodology
The document collaboration maturity model:
• Provides a detailed understanding of your requirements
• Assesses the existing process
• Identifies if there’s a disparity between the two
• Draws conclusions and suggests recommendations
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11. Methodology
Your document
collaboration
requirements
existing processes
against key criteria
all answers
If doc
collaboration
needs are being
met
considerations for
improvement, if
required
2-part questionnaire
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12. Methodology
Your document collaboration requirements
Criteria evaluated include:
‒
‒
‒
‒
‒
Participation
Document characteristics
Process constraints
Frequency
Functionality
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Existing processes
Criteria evaluated include:
‒
‒
‒
‒
‒
Process automation
Functionality provided
IT/user alignment
Usability
Reporting capability
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13. Methodology
Responses to both requirements and existing process are
scored
The results fall into categories from basic to advanced
Whether your existing process is underperforming,
over delivering or is just right!
-
No action required
Improvements should be considered
Do something now
… recommendations are provided, tailored to
responses
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14. Case Study
• Major branded eye healthcare business (~11,000 employees)
• Produces complex documents within RA, RO, QA and Clinical
Research departments
• Require review by multiple individuals (160+ reviewers, typically 25
reviewers/document)
• Had a ‘chaotic’ process: shared directories, PDF and email
• Issues included:
sequential review, no control, manual processes
very time consuming
external parties couldn’t easily access the document
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15. Case Study contd.
• Assessed requirements: 2 key challenges to resolve
simultaneous access to same copy of document
control over the review
• Identified appropriate solution
to meet key process requirements above
to meet IT approval
attended Industry conferences
online research and demos
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16. Case Study contd.
• Actual implementation
company selected not based in the US
selected private cloud solution
•
•
•
•
rapid deployment (up and running in 5 days)
dedicated URL
managed system administration
fully secure and stable
remote training incl. post go-live re-training
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17. Case Study contd.
• Post implementation:
happier users
review owner has control over changes to document
externals have secure simultaneous access to review
time taken to review documents has been ‘cut in half’:
“What used to take days is often achieved in hours”1
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Quote from Clinical Research Manager
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18. Technology options – online editing solutions
- browser-based
- basic editing only
- simultaneous access
- no review management,
control or process
- works through firewall
- users can overwrite/ delete
others’ edits (uncontrolled coauthoring)
- no offline option
cloud
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- no reporting
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19. Technology options – collaborative platforms
- browser-based
- works through firewall
- similar to a shared drive (i.e.
sequential access)
- no review management,
control or process
- users can overwrite/ delete
others’ edits
- can create a real mess!
- no reporting
cloud
cloud
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20. Technology options – document/content management solutions
- some control
- secure
- typically a ‘process’
- annotation only = consolidation
issues
- external access difficult
- tends to be ‘worked around’
by users
- no reporting
cloud
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21. Technology options – SharePoint 2010/2013
- some control
- secure
- co-authoring
- single document
- similar to a shared drive (i.e.
sequential access); or
- users can overwrite/ delete
others’ edits (uncontrolled coauthoring) = real mess potential
- no process, no management,
no reporting, no offline option,
etc.
cloud
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22. Technology options – specialist solutions
- specialist review
functionality
- cost
- co-authoring
- management & control
- secure
- online/offline access
- reporting
cloud
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23. Concluding remarks
• Document collaboration is a key business process
• Drawbacks to many practices
• Market is ‘immature’ though the technology is there
• Education is required
• May need IT’s buy-in
• ROI
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24. About PleaseTech Ltd
•
Established 2002, based in UK
•
Document review and co-authoring specialists
•
Growing & profitable
•
Focus on controlled document collaboration
•
PleaseReview
Collaborative document review and co-authoring
75,000 users across more than 100 organizations
Across Industry sectors and business disciplines
65% business in Life Sciences (incl. medical writing consultancies,
biotech start-ups & ‘top 10’ pharma)
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25. Thank you
Try out the questionnaire yourself at:
http://www.pleasetech.com/collaborationquestionnaire.aspx
Dave Sheppard
david.cornwell@pleasetech.com
www.pleasetech.com
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