StartingPoint Submission Authoring Suite

Accenture's StartingPoint Submission Authoring Suite helps pharmaceutical and biotech companies enable greater speed and efficiency in eCTD authoring, reviewing and publishing submission documents. Visit https://accntu.re/2YlhBp6 to learn more.​

1. Copyright © 2019 Accenture. All rights reserved.
Efficiently Author Your
Submission Documents
STARTINGPOINT
Patient Inspired. Outcomes Driven.

2. Copyright © 2019 Accenture. All rights reserved.
STARTINGPOINT
OVERVIEW
2
Accenture’s industry-
leading submission
authoring solution…
Copyright © 2019 Accenture. All rights reserved.
CONTENT
FEATURES
FUNCTIONALITY
FEATURES
Over 450CTD content templates, each relating to a particular CTD section
•Preset heading styles with appropriate CTD numbering –“boilerplate”
text
•Instructional text –from ICH & regional Guidelines
•Sample text from our Regulatory Affairs group based on our 15+ year
history as a regulatory operator
•A tool to facilitate efficient document authoring through automation in
Microsoft Word. Uses custom styles and macros designed to assist in the
authoring process and to ensure consistent use of styles and standards
•Custom toolbar integrated into the MS Word ribbon as an independent
tab to make commonly-used MS Word functions more accessible
•Offers predefined heading styles, fonts, margins and table formats to
ensure a consistent look and feel across all submission documents
•Advanced authoring tools such as document validation, PLR, Replace
Styles

3. Copyright © 2019 Accenture. All rights reserved.
WHAT IS STARTINGPOINT?
3
Facilitate the preparation
of eSubmission-ready
documents
Help authors to write
in accordance with
relevant specifications
and guidelines
“Turbo-charged”
Microsoft Word
Automated creation of
bookmarks from predefined
styles
Conversion of cross-references
to hyperlinks
Automation of both complex
and routine tasks in MS Word

4. Copyright © 2019 Accenture. All rights reserved.
AN INDUSTRY’S LEADING
AUTHORING SOLUTION
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Used in thousands of electronic submissions
to multiple global agencies
Launched in 2002, with over 25 successful
major and minor releases throughout the tools
tenure

5. Copyright © 2019 Accenture. All rights reserved.
STARTINGPOINT DEPLOYMENT
5
End-user training
is included in the
software license
One full day of end-user
training
Admin/Super-User Training
1
Support
1 hour response time
2
Simple to set up
and maintain
No formal software “install”
One set of StartingPoint
files work across multiple
versions of Microsoft
Windows and Word
3

6. Copyright © 2019 Accenture. All rights reserved. 6
Learn more:
Accenture.com/StartingPoint