Realize the power of document
collaboration
and ease the pain of medical writing

Dave Cornwell
CEO, PleaseTech
AMWA Annua...
Agenda
• Introduction
• Current processes
• The document collaboration maturity model
• Case study
• Technology options
• ...
The reality
• Creating the many complex documents required for clinical
trials, QA and regulatory submissions involves sig...
The reality (contd.)
• Requires secure collaboration with others both within and
outside the organization
• This collabora...
Current processes
Each has its own drawbacks:

email attachments
(Word, PDF)

review meetings

PDF mark up
AMWA Annual Con...
Resulting in…
Email chaos
Lack of control
Multiple reviewed copies
Comment and change
consolidation issues
Meeting frustra...
Current processes
• For some: sufficient for requirements
e.g. few collaborators;
simple, short content
• For others: inef...
The model
Q. Why create a document collaboration maturity model?
A. To ascertain whether your processes meet your
requirem...
The model
• “Collaboration is implicitly assumed, without regard to
how it’s achieved”
• User expectations are often low

...
Methodology
The document collaboration maturity model:
• Provides a detailed understanding of your requirements
• Assesses...
Methodology

Your document
collaboration
requirements

existing processes
against key criteria

all answers

If doc
collab...
Methodology
Your document collaboration requirements
Criteria evaluated include:
‒
‒
‒
‒
‒

Participation
Document charact...
Methodology
Responses to both requirements and existing process are
scored
The results fall into categories from basic to ...
Case Study
• Major branded eye healthcare business (~11,000 employees)
• Produces complex documents within RA, RO, QA and ...
Case Study contd.
• Assessed requirements: 2 key challenges to resolve
simultaneous access to same copy of document
contro...
Case Study contd.
• Actual implementation
company selected not based in the US
selected private cloud solution
•
•
•
•

ra...
Case Study contd.
• Post implementation:
happier users
review owner has control over changes to document
externals have se...
Technology options – online editing solutions

- browser-based

- basic editing only

- simultaneous access

- no review m...
Technology options – collaborative platforms

- browser-based
- works through firewall

- similar to a shared drive (i.e.
...
Technology options – document/content management solutions

- some control
- secure
- typically a ‘process’

- annotation ...
Technology options – SharePoint 2010/2013

- some control
- secure
- co-authoring
- single document

- similar to a shared...
Technology options – specialist solutions

- specialist review
functionality

- cost

- co-authoring
- management & contro...
Concluding remarks
• Document collaboration is a key business process
• Drawbacks to many practices
• Market is ‘immature’...
About PleaseTech Ltd
•

Established 2002, based in UK

•

Document review and co-authoring specialists

•

Growing & profi...
Thank you
Try out the questionnaire yourself at:
http://www.pleasetech.com/collaborationquestionnaire.aspx
Dave Sheppard
d...
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PleaseTech presentation to the American Medical Writers Association

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

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PleaseTech presentation to the American Medical Writers Association

  1. 1. Realize the power of document collaboration and ease the pain of medical writing Dave Cornwell CEO, PleaseTech AMWA Annual Conference AMWA Annual Conference
  2. 2. Agenda • Introduction • Current processes • The document collaboration maturity model • Case study • Technology options • Further information AMWA Annual Conference 2
  3. 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 AMWA Annual Conference 3
  4. 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 AMWA Annual Conference 4
  5. 5. Current processes Each has its own drawbacks: email attachments (Word, PDF) review meetings PDF mark up AMWA Annual Conference SharePoint generic online tools 5
  6. 6. Resulting in… Email chaos Lack of control Multiple reviewed copies Comment and change consolidation issues Meeting frustration Frayed tempers Wasted time Missed deadlines AMWA Annual Conference 6
  7. 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 AMWA Annual Conference 7
  8. 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? AMWA Annual Conference 8
  9. 9. The model • “Collaboration is implicitly assumed, without regard to how it’s achieved” • User expectations are often low AMWA Annual Conference 9
  10. 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 AMWA Annual Conference 10
  11. 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 AMWA Annual Conference 11
  12. 12. Methodology Your document collaboration requirements Criteria evaluated include: ‒ ‒ ‒ ‒ ‒ Participation Document characteristics Process constraints Frequency Functionality AMWA Annual Conference Existing processes Criteria evaluated include: ‒ ‒ ‒ ‒ ‒ Process automation Functionality provided IT/user alignment Usability Reporting capability 12
  13. 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 AMWA Annual Conference 13
  14. 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 AMWA Annual Conference 14
  15. 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 AMWA Annual Conference 15
  16. 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 AMWA Annual Conference 16
  17. 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 AMWA Annual Conference 1 Quote from Clinical Research Manager 17
  18. 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 AMWA Annual Conference - no reporting 18
  19. 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 AMWA Annual Conference 19
  20. 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 AMWA Annual Conference 20
  21. 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 AMWA Annual Conference 21
  22. 22. Technology options – specialist solutions - specialist review functionality - cost - co-authoring - management & control - secure - online/offline access - reporting cloud AMWA Annual Conference 22
  23. 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 AMWA Annual Conference 23
  24. 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) AMWA Annual Conference 24
  25. 25. Thank you Try out the questionnaire yourself at: http://www.pleasetech.com/collaborationquestionnaire.aspx Dave Sheppard david.cornwell@pleasetech.com www.pleasetech.com AMWA Annual Conference

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