PleaseTech presentation to the American Medical Writers Association

AMWA Annual Conference AMWA Annual Conference

Realize the power of document collaboration

and ease the pain of medical writing

Dave Cornwell CEO, PleaseTech


• Introduction

• Current processes

• The document collaboration maturity model

• Case study

• Technology options

• Further information

2

Agenda


• 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:

3

The reality

1 review had just under 140 documents 1 review had over 60 participants 1 review had over 3000 comments


• 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

4

The reality (contd.)


Each has its own drawbacks:

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Current processes

email attachments (Word, PDF)

review meetings

PDF mark up generic online tools

SharePoint


Email chaos

Lack of control

Multiple reviewed copies

Comment and change consolidation issues

Meeting frustration

Frayed tempers

Wasted time

Missed deadlines

6

Resulting in…


• 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

7

Current processes


Q. Why create a document collaboration maturity model?

A. To ascertain whether your processes meet your requirements.

8

The model

Technologies exist that enable controlled document collaboration – have your processes kept up with the times?


• “Collaboration is implicitly assumed, without regard to how it’s achieved”

• User expectations are often low

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The model


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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11

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


• 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

14

Case Study


• 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.


• 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

17

Case Study contd.

1 Quote from Clinical Research Manager


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


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


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.


Technology options – specialist solutions

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cloud

- specialist review functionality

- co-authoring - management & control - secure - online/offline access - reporting

- cost


• 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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AMWA Annual Conference

Thank you

Try out the questionnaire yourself at:

http://www.pleasetech.com/collaborationquestionnaire.aspx

Dave Sheppard [email protected]

www.pleasetech.com

http://www.pleasetech.com/collaborationquestionnaire.aspx

mailto:[email protected]

http://www.pleasetech.com/