SlideShare a Scribd company logo
1 of 6
Download to read offline
Copyright © 2019 Accenture. All rights reserved.
Efficiently Author Your
Submission Documents
STARTINGPOINT
Patient Inspired. Outcomes Driven.
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
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
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
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
Copyright © 2019 Accenture. All rights reserved. 6
Learn more:
Accenture.com/StartingPoint

More Related Content

What's hot

Dossier format and filing.pptx
Dossier format and filing.pptxDossier format and filing.pptx
Dossier format and filing.pptxPrachiSharma575050
 
Electronic Common Technical Document (eCTD)
Electronic Common Technical Document (eCTD)Electronic Common Technical Document (eCTD)
Electronic Common Technical Document (eCTD)Md. Zakaria Faruki
 
New drug and ct rules 2019
New drug and ct rules 2019New drug and ct rules 2019
New drug and ct rules 2019Prasad Bhat
 
Clinical Research Regulation in European Union
Clinical Research Regulation in European Union Clinical Research Regulation in European Union
Clinical Research Regulation in European Union ShantanuThakre3
 
overview of Japan pharmaceutical regulatory authority - PMDA
overview of Japan  pharmaceutical regulatory authority - PMDAoverview of Japan  pharmaceutical regulatory authority - PMDA
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
 
Paper crf design_tools
Paper crf design_toolsPaper crf design_tools
Paper crf design_toolsDave John
 
US DMF Preparation and submission
US DMF Preparation and submissionUS DMF Preparation and submission
US DMF Preparation and submissionBhanu Chava
 
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPANMEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPANDeveshDRA
 
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTS
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTS21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTS
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
 
common technical document vs electronic common technical document
common technical document vs electronic common technical document common technical document vs electronic common technical document
common technical document vs electronic common technical document MayankGupta851
 
NDA Application.pptx
NDA Application.pptxNDA Application.pptx
NDA Application.pptxVenugopal N
 
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...Until ROI
 
Importance of aggregate reporting in pharmacovigilance
Importance of aggregate reporting in pharmacovigilanceImportance of aggregate reporting in pharmacovigilance
Importance of aggregate reporting in pharmacovigilanceSollers College
 
Commonwealth of independent states
Commonwealth of independent statesCommonwealth of independent states
Commonwealth of independent statesgarimasaini33
 
Pharma regulatory affairs
Pharma regulatory affairsPharma regulatory affairs
Pharma regulatory affairsGirish Swami
 
Risk Management In Pharmacovigilance
Risk Management In PharmacovigilanceRisk Management In Pharmacovigilance
Risk Management In PharmacovigilanceRosmirella Cano Rojas
 

What's hot (20)

Dossier format and filing.pptx
Dossier format and filing.pptxDossier format and filing.pptx
Dossier format and filing.pptx
 
Electronic Common Technical Document (eCTD)
Electronic Common Technical Document (eCTD)Electronic Common Technical Document (eCTD)
Electronic Common Technical Document (eCTD)
 
Fda guidance for pharmaceutical post marketing reporting professor pirouzi
Fda guidance for pharmaceutical post marketing reporting   professor pirouziFda guidance for pharmaceutical post marketing reporting   professor pirouzi
Fda guidance for pharmaceutical post marketing reporting professor pirouzi
 
New drug and ct rules 2019
New drug and ct rules 2019New drug and ct rules 2019
New drug and ct rules 2019
 
Clinical Research Regulation in European Union
Clinical Research Regulation in European Union Clinical Research Regulation in European Union
Clinical Research Regulation in European Union
 
Ghtf study group 4
Ghtf study group 4Ghtf study group 4
Ghtf study group 4
 
overview of Japan pharmaceutical regulatory authority - PMDA
overview of Japan  pharmaceutical regulatory authority - PMDAoverview of Japan  pharmaceutical regulatory authority - PMDA
overview of Japan pharmaceutical regulatory authority - PMDA
 
Paper crf design_tools
Paper crf design_toolsPaper crf design_tools
Paper crf design_tools
 
US DMF Preparation and submission
US DMF Preparation and submissionUS DMF Preparation and submission
US DMF Preparation and submission
 
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPANMEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
 
Ctd and e ctd
Ctd and e ctdCtd and e ctd
Ctd and e ctd
 
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTS
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTS21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTS
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTS
 
common technical document vs electronic common technical document
common technical document vs electronic common technical document common technical document vs electronic common technical document
common technical document vs electronic common technical document
 
NDA Application.pptx
NDA Application.pptxNDA Application.pptx
NDA Application.pptx
 
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
 
Importance of aggregate reporting in pharmacovigilance
Importance of aggregate reporting in pharmacovigilanceImportance of aggregate reporting in pharmacovigilance
Importance of aggregate reporting in pharmacovigilance
 
Commonwealth of independent states
Commonwealth of independent statesCommonwealth of independent states
Commonwealth of independent states
 
Pharma regulatory affairs
Pharma regulatory affairsPharma regulatory affairs
Pharma regulatory affairs
 
Japanese regulatory affairs
Japanese regulatory affairsJapanese regulatory affairs
Japanese regulatory affairs
 
Risk Management In Pharmacovigilance
Risk Management In PharmacovigilanceRisk Management In Pharmacovigilance
Risk Management In Pharmacovigilance
 

Similar to StartingPoint Submission Authoring Suite

Accenture Regulatory Services
Accenture Regulatory ServicesAccenture Regulatory Services
Accenture Regulatory Servicesaccenture
 
Information Systems and Security Grading Guide BIS221 Versi.docx
Information Systems and Security Grading Guide BIS221 Versi.docxInformation Systems and Security Grading Guide BIS221 Versi.docx
Information Systems and Security Grading Guide BIS221 Versi.docxjaggernaoma
 
Using Checker Software for Clear, Concise and Consistent Content | Berry Braster
Using Checker Software for Clear, Concise and Consistent Content | Berry BrasterUsing Checker Software for Clear, Concise and Consistent Content | Berry Braster
Using Checker Software for Clear, Concise and Consistent Content | Berry BrasterLavaConConference
 
Sumithranandan_TechnicalWriter_10+Yrs_Exp
Sumithranandan_TechnicalWriter_10+Yrs_ExpSumithranandan_TechnicalWriter_10+Yrs_Exp
Sumithranandan_TechnicalWriter_10+Yrs_ExpSumitra Nandan
 
Resume_PriyaBharatia_TechnicalWriter
Resume_PriyaBharatia_TechnicalWriterResume_PriyaBharatia_TechnicalWriter
Resume_PriyaBharatia_TechnicalWriterPriya Bharatia
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyerDee Dwyer
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyerDee Dwyer
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyerDee Dwyer
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyerDee Dwyer
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyerDee Dwyer
 
Metadata Modeling Best Practices with IBM Cognos Framework Manager
Metadata Modeling Best Practices with IBM Cognos Framework ManagerMetadata Modeling Best Practices with IBM Cognos Framework Manager
Metadata Modeling Best Practices with IBM Cognos Framework ManagerSenturus
 
Modernize Your Content Publishing Process with Smart Content
Modernize Your Content Publishing Process with Smart ContentModernize Your Content Publishing Process with Smart Content
Modernize Your Content Publishing Process with Smart ContentGavin Drake
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyerDee Dwyer
 
Self-Service Business Authoring in a Managed Reporting World: IBM Cognos Work...
Self-Service Business Authoring in a Managed Reporting World: IBM Cognos Work...Self-Service Business Authoring in a Managed Reporting World: IBM Cognos Work...
Self-Service Business Authoring in a Managed Reporting World: IBM Cognos Work...Senturus
 
Saikrishna_Bejjanki_HP Exstream Developer
Saikrishna_Bejjanki_HP Exstream DeveloperSaikrishna_Bejjanki_HP Exstream Developer
Saikrishna_Bejjanki_HP Exstream DeveloperSaikrishna Bejjanki
 
Ruth Preston March 2015
Ruth Preston March 2015Ruth Preston March 2015
Ruth Preston March 2015Ruth Preston
 
Smart Document Screening
Smart Document ScreeningSmart Document Screening
Smart Document ScreeningStenWery
 
Team Me Up Scotty SPSOslo w.Extending
Team Me Up Scotty SPSOslo w.ExtendingTeam Me Up Scotty SPSOslo w.Extending
Team Me Up Scotty SPSOslo w.ExtendingThorbjørn Værp
 

Similar to StartingPoint Submission Authoring Suite (20)

Accenture Regulatory Services
Accenture Regulatory ServicesAccenture Regulatory Services
Accenture Regulatory Services
 
Information Systems and Security Grading Guide BIS221 Versi.docx
Information Systems and Security Grading Guide BIS221 Versi.docxInformation Systems and Security Grading Guide BIS221 Versi.docx
Information Systems and Security Grading Guide BIS221 Versi.docx
 
Using Checker Software for Clear, Concise and Consistent Content | Berry Braster
Using Checker Software for Clear, Concise and Consistent Content | Berry BrasterUsing Checker Software for Clear, Concise and Consistent Content | Berry Braster
Using Checker Software for Clear, Concise and Consistent Content | Berry Braster
 
Sumithranandan_TechnicalWriter_10+Yrs_Exp
Sumithranandan_TechnicalWriter_10+Yrs_ExpSumithranandan_TechnicalWriter_10+Yrs_Exp
Sumithranandan_TechnicalWriter_10+Yrs_Exp
 
Resume charles vermette
Resume   charles vermetteResume   charles vermette
Resume charles vermette
 
Resume charles vermette
Resume   charles vermetteResume   charles vermette
Resume charles vermette
 
Resume_PriyaBharatia_TechnicalWriter
Resume_PriyaBharatia_TechnicalWriterResume_PriyaBharatia_TechnicalWriter
Resume_PriyaBharatia_TechnicalWriter
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyer
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyer
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyer
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyer
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyer
 
Metadata Modeling Best Practices with IBM Cognos Framework Manager
Metadata Modeling Best Practices with IBM Cognos Framework ManagerMetadata Modeling Best Practices with IBM Cognos Framework Manager
Metadata Modeling Best Practices with IBM Cognos Framework Manager
 
Modernize Your Content Publishing Process with Smart Content
Modernize Your Content Publishing Process with Smart ContentModernize Your Content Publishing Process with Smart Content
Modernize Your Content Publishing Process with Smart Content
 
Deirdra dwyer
Deirdra dwyerDeirdra dwyer
Deirdra dwyer
 
Self-Service Business Authoring in a Managed Reporting World: IBM Cognos Work...
Self-Service Business Authoring in a Managed Reporting World: IBM Cognos Work...Self-Service Business Authoring in a Managed Reporting World: IBM Cognos Work...
Self-Service Business Authoring in a Managed Reporting World: IBM Cognos Work...
 
Saikrishna_Bejjanki_HP Exstream Developer
Saikrishna_Bejjanki_HP Exstream DeveloperSaikrishna_Bejjanki_HP Exstream Developer
Saikrishna_Bejjanki_HP Exstream Developer
 
Ruth Preston March 2015
Ruth Preston March 2015Ruth Preston March 2015
Ruth Preston March 2015
 
Smart Document Screening
Smart Document ScreeningSmart Document Screening
Smart Document Screening
 
Team Me Up Scotty SPSOslo w.Extending
Team Me Up Scotty SPSOslo w.ExtendingTeam Me Up Scotty SPSOslo w.Extending
Team Me Up Scotty SPSOslo w.Extending
 

More from accenture

The Industrialist: Trends & Innovations - January 2024
The Industrialist: Trends & Innovations - January 2024The Industrialist: Trends & Innovations - January 2024
The Industrialist: Trends & Innovations - January 2024accenture
 
The Industrialist: Trends & Innovations - September 2023
The Industrialist: Trends & Innovations - September 2023The Industrialist: Trends & Innovations - September 2023
The Industrialist: Trends & Innovations - September 2023accenture
 
Accenture Technology Vision - How the trends apply to higher education
Accenture Technology Vision - How the trends apply to higher education Accenture Technology Vision - How the trends apply to higher education
Accenture Technology Vision - How the trends apply to higher education accenture
 
The Industrialist: Trends & Innovations - July 2023
The Industrialist: Trends & Innovations - July 2023The Industrialist: Trends & Innovations - July 2023
The Industrialist: Trends & Innovations - July 2023accenture
 
Accenture Technology Vision - How the trends apply to higher education
Accenture Technology Vision - How the trends apply to higher education Accenture Technology Vision - How the trends apply to higher education
Accenture Technology Vision - How the trends apply to higher education accenture
 
Engineering Services: con gli ingegneri per creare valore sostenibile
Engineering Services: con gli ingegneri per creare valore sostenibileEngineering Services: con gli ingegneri per creare valore sostenibile
Engineering Services: con gli ingegneri per creare valore sostenibileaccenture
 
Digital Euro: Implications for the Financial System
Digital Euro: Implications for the Financial SystemDigital Euro: Implications for the Financial System
Digital Euro: Implications for the Financial Systemaccenture
 
More deals, less money: the Black founder funding journey
More deals, less money: the Black founder funding journeyMore deals, less money: the Black founder funding journey
More deals, less money: the Black founder funding journeyaccenture
 
The Industrialist: Trends & Innovations - June 2023
The Industrialist: Trends & Innovations - June 2023The Industrialist: Trends & Innovations - June 2023
The Industrialist: Trends & Innovations - June 2023accenture
 
Reinventing Enterprise Operations
Reinventing Enterprise OperationsReinventing Enterprise Operations
Reinventing Enterprise Operationsaccenture
 
Semiconductor Gender Parity Study
Semiconductor Gender Parity StudySemiconductor Gender Parity Study
Semiconductor Gender Parity Studyaccenture
 
The Industrialist: Trends & Innovations - March 2023
The Industrialist: Trends & Innovations - March 2023The Industrialist: Trends & Innovations - March 2023
The Industrialist: Trends & Innovations - March 2023accenture
 
Nonprofit reinvention in a time of unprecedented change
 Nonprofit reinvention in a time of unprecedented change Nonprofit reinvention in a time of unprecedented change
Nonprofit reinvention in a time of unprecedented changeaccenture
 
Free to be 100% me
Free to be 100% meFree to be 100% me
Free to be 100% meaccenture
 
The Industrialist: Trends & Innovations - February 2023
The Industrialist: Trends & Innovations - February 2023The Industrialist: Trends & Innovations - February 2023
The Industrialist: Trends & Innovations - February 2023accenture
 
Mundo gamer e a oportunidade de entrada pela abordagem do movimento
Mundo gamer e a oportunidade de entrada pela abordagem do movimentoMundo gamer e a oportunidade de entrada pela abordagem do movimento
Mundo gamer e a oportunidade de entrada pela abordagem do movimentoaccenture
 
Pathways to Profitability for the Communications Industry
Pathways to Profitability for the Communications IndustryPathways to Profitability for the Communications Industry
Pathways to Profitability for the Communications Industryaccenture
 
The Industrialist: Trends & Innovations - January 2023
The Industrialist: Trends & Innovations - January 2023The Industrialist: Trends & Innovations - January 2023
The Industrialist: Trends & Innovations - January 2023accenture
 
Reimagining the Agenda | Accenture
Reimagining the Agenda | AccentureReimagining the Agenda | Accenture
Reimagining the Agenda | Accentureaccenture
 
Climate Leadership Eleventh Hour | Accenture
Climate Leadership Eleventh Hour | AccentureClimate Leadership Eleventh Hour | Accenture
Climate Leadership Eleventh Hour | Accentureaccenture
 

More from accenture (20)

The Industrialist: Trends & Innovations - January 2024
The Industrialist: Trends & Innovations - January 2024The Industrialist: Trends & Innovations - January 2024
The Industrialist: Trends & Innovations - January 2024
 
The Industrialist: Trends & Innovations - September 2023
The Industrialist: Trends & Innovations - September 2023The Industrialist: Trends & Innovations - September 2023
The Industrialist: Trends & Innovations - September 2023
 
Accenture Technology Vision - How the trends apply to higher education
Accenture Technology Vision - How the trends apply to higher education Accenture Technology Vision - How the trends apply to higher education
Accenture Technology Vision - How the trends apply to higher education
 
The Industrialist: Trends & Innovations - July 2023
The Industrialist: Trends & Innovations - July 2023The Industrialist: Trends & Innovations - July 2023
The Industrialist: Trends & Innovations - July 2023
 
Accenture Technology Vision - How the trends apply to higher education
Accenture Technology Vision - How the trends apply to higher education Accenture Technology Vision - How the trends apply to higher education
Accenture Technology Vision - How the trends apply to higher education
 
Engineering Services: con gli ingegneri per creare valore sostenibile
Engineering Services: con gli ingegneri per creare valore sostenibileEngineering Services: con gli ingegneri per creare valore sostenibile
Engineering Services: con gli ingegneri per creare valore sostenibile
 
Digital Euro: Implications for the Financial System
Digital Euro: Implications for the Financial SystemDigital Euro: Implications for the Financial System
Digital Euro: Implications for the Financial System
 
More deals, less money: the Black founder funding journey
More deals, less money: the Black founder funding journeyMore deals, less money: the Black founder funding journey
More deals, less money: the Black founder funding journey
 
The Industrialist: Trends & Innovations - June 2023
The Industrialist: Trends & Innovations - June 2023The Industrialist: Trends & Innovations - June 2023
The Industrialist: Trends & Innovations - June 2023
 
Reinventing Enterprise Operations
Reinventing Enterprise OperationsReinventing Enterprise Operations
Reinventing Enterprise Operations
 
Semiconductor Gender Parity Study
Semiconductor Gender Parity StudySemiconductor Gender Parity Study
Semiconductor Gender Parity Study
 
The Industrialist: Trends & Innovations - March 2023
The Industrialist: Trends & Innovations - March 2023The Industrialist: Trends & Innovations - March 2023
The Industrialist: Trends & Innovations - March 2023
 
Nonprofit reinvention in a time of unprecedented change
 Nonprofit reinvention in a time of unprecedented change Nonprofit reinvention in a time of unprecedented change
Nonprofit reinvention in a time of unprecedented change
 
Free to be 100% me
Free to be 100% meFree to be 100% me
Free to be 100% me
 
The Industrialist: Trends & Innovations - February 2023
The Industrialist: Trends & Innovations - February 2023The Industrialist: Trends & Innovations - February 2023
The Industrialist: Trends & Innovations - February 2023
 
Mundo gamer e a oportunidade de entrada pela abordagem do movimento
Mundo gamer e a oportunidade de entrada pela abordagem do movimentoMundo gamer e a oportunidade de entrada pela abordagem do movimento
Mundo gamer e a oportunidade de entrada pela abordagem do movimento
 
Pathways to Profitability for the Communications Industry
Pathways to Profitability for the Communications IndustryPathways to Profitability for the Communications Industry
Pathways to Profitability for the Communications Industry
 
The Industrialist: Trends & Innovations - January 2023
The Industrialist: Trends & Innovations - January 2023The Industrialist: Trends & Innovations - January 2023
The Industrialist: Trends & Innovations - January 2023
 
Reimagining the Agenda | Accenture
Reimagining the Agenda | AccentureReimagining the Agenda | Accenture
Reimagining the Agenda | Accenture
 
Climate Leadership Eleventh Hour | Accenture
Climate Leadership Eleventh Hour | AccentureClimate Leadership Eleventh Hour | Accenture
Climate Leadership Eleventh Hour | Accenture
 

Recently uploaded

Partners Life - Insurer Innovation Award 2024
Partners Life - Insurer Innovation Award 2024Partners Life - Insurer Innovation Award 2024
Partners Life - Insurer Innovation Award 2024The Digital Insurer
 
Apidays New York 2024 - Scaling API-first by Ian Reasor and Radu Cotescu, Adobe
Apidays New York 2024 - Scaling API-first by Ian Reasor and Radu Cotescu, AdobeApidays New York 2024 - Scaling API-first by Ian Reasor and Radu Cotescu, Adobe
Apidays New York 2024 - Scaling API-first by Ian Reasor and Radu Cotescu, Adobeapidays
 
A Year of the Servo Reboot: Where Are We Now?
A Year of the Servo Reboot: Where Are We Now?A Year of the Servo Reboot: Where Are We Now?
A Year of the Servo Reboot: Where Are We Now?Igalia
 
Repurposing LNG terminals for Hydrogen Ammonia: Feasibility and Cost Saving
Repurposing LNG terminals for Hydrogen Ammonia: Feasibility and Cost SavingRepurposing LNG terminals for Hydrogen Ammonia: Feasibility and Cost Saving
Repurposing LNG terminals for Hydrogen Ammonia: Feasibility and Cost SavingEdi Saputra
 
Axa Assurance Maroc - Insurer Innovation Award 2024
Axa Assurance Maroc - Insurer Innovation Award 2024Axa Assurance Maroc - Insurer Innovation Award 2024
Axa Assurance Maroc - Insurer Innovation Award 2024The Digital Insurer
 
Top 10 Most Downloaded Games on Play Store in 2024
Top 10 Most Downloaded Games on Play Store in 2024Top 10 Most Downloaded Games on Play Store in 2024
Top 10 Most Downloaded Games on Play Store in 2024SynarionITSolutions
 
Apidays Singapore 2024 - Building Digital Trust in a Digital Economy by Veron...
Apidays Singapore 2024 - Building Digital Trust in a Digital Economy by Veron...Apidays Singapore 2024 - Building Digital Trust in a Digital Economy by Veron...
Apidays Singapore 2024 - Building Digital Trust in a Digital Economy by Veron...apidays
 
2024: Domino Containers - The Next Step. News from the Domino Container commu...
2024: Domino Containers - The Next Step. News from the Domino Container commu...2024: Domino Containers - The Next Step. News from the Domino Container commu...
2024: Domino Containers - The Next Step. News from the Domino Container commu...Martijn de Jong
 
From Event to Action: Accelerate Your Decision Making with Real-Time Automation
From Event to Action: Accelerate Your Decision Making with Real-Time AutomationFrom Event to Action: Accelerate Your Decision Making with Real-Time Automation
From Event to Action: Accelerate Your Decision Making with Real-Time AutomationSafe Software
 
Powerful Google developer tools for immediate impact! (2023-24 C)
Powerful Google developer tools for immediate impact! (2023-24 C)Powerful Google developer tools for immediate impact! (2023-24 C)
Powerful Google developer tools for immediate impact! (2023-24 C)wesley chun
 
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...Miguel Araújo
 
Artificial Intelligence: Facts and Myths
Artificial Intelligence: Facts and MythsArtificial Intelligence: Facts and Myths
Artificial Intelligence: Facts and MythsJoaquim Jorge
 
The 7 Things I Know About Cyber Security After 25 Years | April 2024
The 7 Things I Know About Cyber Security After 25 Years | April 2024The 7 Things I Know About Cyber Security After 25 Years | April 2024
The 7 Things I Know About Cyber Security After 25 Years | April 2024Rafal Los
 
Data Cloud, More than a CDP by Matt Robison
Data Cloud, More than a CDP by Matt RobisonData Cloud, More than a CDP by Matt Robison
Data Cloud, More than a CDP by Matt RobisonAnna Loughnan Colquhoun
 
How to Troubleshoot Apps for the Modern Connected Worker
How to Troubleshoot Apps for the Modern Connected WorkerHow to Troubleshoot Apps for the Modern Connected Worker
How to Troubleshoot Apps for the Modern Connected WorkerThousandEyes
 
Connector Corner: Accelerate revenue generation using UiPath API-centric busi...
Connector Corner: Accelerate revenue generation using UiPath API-centric busi...Connector Corner: Accelerate revenue generation using UiPath API-centric busi...
Connector Corner: Accelerate revenue generation using UiPath API-centric busi...DianaGray10
 
Bajaj Allianz Life Insurance Company - Insurer Innovation Award 2024
Bajaj Allianz Life Insurance Company - Insurer Innovation Award 2024Bajaj Allianz Life Insurance Company - Insurer Innovation Award 2024
Bajaj Allianz Life Insurance Company - Insurer Innovation Award 2024The Digital Insurer
 
ProductAnonymous-April2024-WinProductDiscovery-MelissaKlemke
ProductAnonymous-April2024-WinProductDiscovery-MelissaKlemkeProductAnonymous-April2024-WinProductDiscovery-MelissaKlemke
ProductAnonymous-April2024-WinProductDiscovery-MelissaKlemkeProduct Anonymous
 
Automating Google Workspace (GWS) & more with Apps Script
Automating Google Workspace (GWS) & more with Apps ScriptAutomating Google Workspace (GWS) & more with Apps Script
Automating Google Workspace (GWS) & more with Apps Scriptwesley chun
 

Recently uploaded (20)

Partners Life - Insurer Innovation Award 2024
Partners Life - Insurer Innovation Award 2024Partners Life - Insurer Innovation Award 2024
Partners Life - Insurer Innovation Award 2024
 
Apidays New York 2024 - Scaling API-first by Ian Reasor and Radu Cotescu, Adobe
Apidays New York 2024 - Scaling API-first by Ian Reasor and Radu Cotescu, AdobeApidays New York 2024 - Scaling API-first by Ian Reasor and Radu Cotescu, Adobe
Apidays New York 2024 - Scaling API-first by Ian Reasor and Radu Cotescu, Adobe
 
A Year of the Servo Reboot: Where Are We Now?
A Year of the Servo Reboot: Where Are We Now?A Year of the Servo Reboot: Where Are We Now?
A Year of the Servo Reboot: Where Are We Now?
 
Repurposing LNG terminals for Hydrogen Ammonia: Feasibility and Cost Saving
Repurposing LNG terminals for Hydrogen Ammonia: Feasibility and Cost SavingRepurposing LNG terminals for Hydrogen Ammonia: Feasibility and Cost Saving
Repurposing LNG terminals for Hydrogen Ammonia: Feasibility and Cost Saving
 
Axa Assurance Maroc - Insurer Innovation Award 2024
Axa Assurance Maroc - Insurer Innovation Award 2024Axa Assurance Maroc - Insurer Innovation Award 2024
Axa Assurance Maroc - Insurer Innovation Award 2024
 
+971581248768>> SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHA...
+971581248768>> SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHA...+971581248768>> SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHA...
+971581248768>> SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHA...
 
Top 10 Most Downloaded Games on Play Store in 2024
Top 10 Most Downloaded Games on Play Store in 2024Top 10 Most Downloaded Games on Play Store in 2024
Top 10 Most Downloaded Games on Play Store in 2024
 
Apidays Singapore 2024 - Building Digital Trust in a Digital Economy by Veron...
Apidays Singapore 2024 - Building Digital Trust in a Digital Economy by Veron...Apidays Singapore 2024 - Building Digital Trust in a Digital Economy by Veron...
Apidays Singapore 2024 - Building Digital Trust in a Digital Economy by Veron...
 
2024: Domino Containers - The Next Step. News from the Domino Container commu...
2024: Domino Containers - The Next Step. News from the Domino Container commu...2024: Domino Containers - The Next Step. News from the Domino Container commu...
2024: Domino Containers - The Next Step. News from the Domino Container commu...
 
From Event to Action: Accelerate Your Decision Making with Real-Time Automation
From Event to Action: Accelerate Your Decision Making with Real-Time AutomationFrom Event to Action: Accelerate Your Decision Making with Real-Time Automation
From Event to Action: Accelerate Your Decision Making with Real-Time Automation
 
Powerful Google developer tools for immediate impact! (2023-24 C)
Powerful Google developer tools for immediate impact! (2023-24 C)Powerful Google developer tools for immediate impact! (2023-24 C)
Powerful Google developer tools for immediate impact! (2023-24 C)
 
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
 
Artificial Intelligence: Facts and Myths
Artificial Intelligence: Facts and MythsArtificial Intelligence: Facts and Myths
Artificial Intelligence: Facts and Myths
 
The 7 Things I Know About Cyber Security After 25 Years | April 2024
The 7 Things I Know About Cyber Security After 25 Years | April 2024The 7 Things I Know About Cyber Security After 25 Years | April 2024
The 7 Things I Know About Cyber Security After 25 Years | April 2024
 
Data Cloud, More than a CDP by Matt Robison
Data Cloud, More than a CDP by Matt RobisonData Cloud, More than a CDP by Matt Robison
Data Cloud, More than a CDP by Matt Robison
 
How to Troubleshoot Apps for the Modern Connected Worker
How to Troubleshoot Apps for the Modern Connected WorkerHow to Troubleshoot Apps for the Modern Connected Worker
How to Troubleshoot Apps for the Modern Connected Worker
 
Connector Corner: Accelerate revenue generation using UiPath API-centric busi...
Connector Corner: Accelerate revenue generation using UiPath API-centric busi...Connector Corner: Accelerate revenue generation using UiPath API-centric busi...
Connector Corner: Accelerate revenue generation using UiPath API-centric busi...
 
Bajaj Allianz Life Insurance Company - Insurer Innovation Award 2024
Bajaj Allianz Life Insurance Company - Insurer Innovation Award 2024Bajaj Allianz Life Insurance Company - Insurer Innovation Award 2024
Bajaj Allianz Life Insurance Company - Insurer Innovation Award 2024
 
ProductAnonymous-April2024-WinProductDiscovery-MelissaKlemke
ProductAnonymous-April2024-WinProductDiscovery-MelissaKlemkeProductAnonymous-April2024-WinProductDiscovery-MelissaKlemke
ProductAnonymous-April2024-WinProductDiscovery-MelissaKlemke
 
Automating Google Workspace (GWS) & more with Apps Script
Automating Google Workspace (GWS) & more with Apps ScriptAutomating Google Workspace (GWS) & more with Apps Script
Automating Google Workspace (GWS) & more with Apps Script
 

StartingPoint Submission Authoring Suite

  • 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 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. 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 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. 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