pleasetech presentation to the american medical writers association
TRANSCRIPT
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Realize the power of document collaboration
and ease the pain of medical writing
Dave Cornwell CEO, PleaseTech
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• Introduction
• Current processes
• The document collaboration maturity model
• Case study
• Technology options
• Further information
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Agenda
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• 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:
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The reality
1 review had just under 140 documents 1 review had over 60 participants 1 review had over 3000 comments
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• 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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The reality (contd.)
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Each has its own drawbacks:
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Current processes
email attachments (Word, PDF)
review meetings
PDF mark up generic online tools
SharePoint
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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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Resulting in…
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• 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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Current processes
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Q. Why create a document collaboration maturity model?
A. To ascertain whether your processes meet your requirements.
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The model
Technologies exist that enable controlled document collaboration – have your processes kept up with the times?
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• “Collaboration is implicitly assumed, without regard to how it’s achieved”
• User expectations are often low
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The model
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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
Methodology
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Methodology
existing processes against key criteria
all answers considerations for improvement, if required
2-part questionnaire
Your document collaboration requirements
If doc collaboration needs are being met
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Methodology
Criteria evaluated include:
‒ Participation ‒ Document characteristics ‒ Process constraints ‒ Frequency ‒ Functionality
Your document collaboration requirements
Existing processes
Criteria evaluated include: ‒ Process automation ‒ Functionality provided ‒ IT/user alignment ‒ Usability ‒ Reporting capability
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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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• 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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Case Study
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• 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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Case Study contd.
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• 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
Case Study contd.
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• 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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Case Study contd.
1 Quote from Clinical Research Manager
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Technology options – online editing solutions
- browser-based - simultaneous access - works through firewall
- basic editing only - no review management,
control or process - users can overwrite/ delete
others’ edits (uncontrolled co-authoring)
- no offline option - no reporting cloud
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Technology options – collaborative platforms
cloud
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- 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
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Technology options – document/content management solutions
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cloud
- some control - secure - typically a ‘process’
- annotation only = consolidation issues
- external access difficult - tends to be ‘worked around’
by users - no reporting
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Technology options – SharePoint 2010/2013
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cloud
- some control - secure - co-authoring - single document
- similar to a shared drive (i.e. sequential access); or
- users can overwrite/ delete others’ edits (uncontrolled co-authoring) = real mess potential
- no process, no management, no reporting, no offline option, etc.
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Technology options – specialist solutions
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cloud
- specialist review functionality
- co-authoring - management & control - secure - online/offline access - reporting
- cost
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• 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
Concluding remarks
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• 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)
About PleaseTech Ltd
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Thank you
Try out the questionnaire yourself at:
http://www.pleasetech.com/collaborationquestionnaire.aspx
Dave Sheppard [email protected]
www.pleasetech.com