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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.​

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StartingPoint Submission Authoring Suite

  1. 1. Copyright © 2019 Accenture. All rights reserved. Efficiently Author Your Submission Documents STARTINGPOINT Patient Inspired. Outcomes Driven.
  2. 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 450 CTD 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. 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. 4. Copyright © 2019 Accenture. All rights reserved. AN INDUSTRY’S LEADING AUTHORING SOLUTION 4 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. 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. 6. Copyright © 2019 Accenture. All rights reserved. 6 Learn more: Accenture.com/StartingPoint