SlideShare una empresa de Scribd logo
1 de 16
10 Benefits TMF Managers
are Achieving with eTMF
Systems
 Track status of TMF content documents:
completed, filed, or missing
 Verify status in real-time from any location
 Access tools, such as reports and data
exportation
Benefit 1 |
Real-Time Tracking &
Viewing of Documents
© 2017 All Rights Reserved.
Benefit 2 |
Easier to Search & Find Documents
 Create and upload documents directly in the system
 Search documents based on metadata and content
 Organize documents on pre-defined TMF structure
 Easily locate, retrieve, and view specific documents
© 2017 All Rights Reserved.
 Increase speed of Study Start-Up
 Provides central location for information and documentation; always up-
to-date with the latest versions
 Improves collaboration between trial stakeholders and clinical teams
 Pre-defined templates for document creation
 Increase speed of Study Close-Out
 Progressive and continuous compilation of TMF; no end of study rush
 Continuous quality control of documents
Benefit 3 |
Shortened Clinical Trial Time
© 2017 All Rights Reserved.
 Simplify communications, process, and
collaboration with IRBs and IECs
 Provide access to specific documents
and create IRB/IEC portals
Benefit 4 |
Easier Collaboration with
IRBs/IECs
© 2017 All Rights Reserved.
 Tracking & Accountability of TMF
Content
 Track when the reception, review,
quality control, and filing take place
Benefit 5 |
Increase TMF SOP Compliance
 Timeliness of TMF Compilation
 Identifies required documentation;
dividing them into expected and
outstanding documentation
© 2017 All Rights Reserved.
 Extract key business intelligence
from documents in the system
 Embedded analytics for better
decision making
Benefit 6 |
Better Visibility into Key Trial Performance Metrics
© 2017 All Rights Reserved.
 Eliminates costs associated with paper document storage
 Eliminates costs associated with managing snail mail, scanning, filing & refiling,
and retrieving documents
Benefit 7 |
Cost Savings
© 2017 All Rights Reserved.
Our customizable Paper-Based System Cost Calculator lets you input a few
basic metrics and tells you all the information you need to know!
Ever wonder how much your paper system is
actually costing you?
Free Download
© 2017 All Rights Reserved.
 Eliminates document overlap
 Document versions are always up-to-
date and easily accessible
 Simplified TMF compilation
Benefit 8 |
Easier Collaboration with Sites
 Allows all records, documents, and information
to be available and accessible
 Ensures documents have undergone formal
quality control
 Provides tools for filtered view to facilitate
inspection
 Reports generated by system indicate what is
required for inspection and what needs to be
completed
Benefit 9 |
Improved Audit &
Inspection Readiness
© 2017 All Rights Reserved.
 All TMF content in one electronic location,
meaning no need to physically transfer paper
documents
 Eliminates overhead costs associated with the
shipment of documents
 All pertinent information located in central
location
Benefit 10 |
Easier Collaboration with
CROs
© 2017 All Rights Reserved.
The Future of eTMF
Convergence of Clinical Data
 Combination of documents and data from
ancillary systems
 Integration and connection of information
sources to eliminate information silos
 Improved collaboration and tracking
information sharing between sponsors,
CROs and clinical sites
© 2017 All Rights Reserved.
Key Takeaways
 Improved and simplified collaboration between
sponsors, CROs, and clinical sites
 All content in one central location; always
accessible and always up-to-date
 All content is tracked and given a status
 Improved quality control and compliance
 Always inspection ready
 Cost savings due to the elimination of paper
documents
© 2017 All Rights Reserved.
www.montrium.com
© 2017 Montrium. All Rights Reserved.
15
The Smart Way to Manage TMF
Content
CLICK TO EXPLORE
© 2017 All Rights Reserved.
Key Features
eTMF Connect
Complete eTMF Configuration
based on TMF RM
Automatic Classification of
Artifacts
Configurable & Intuitive
Workflows
Clinical Inbox for External
Documents
Bath Indexing & Auto-
filing of Records
eTMF Navigator
© 2017 All Rights Reserved.

Más contenido relacionado

Más de Montrium

Monitoring Beyond COVID-19: Setting Yourself Up for the New-Normal
Monitoring Beyond COVID-19: Setting Yourself Up for the New-NormalMonitoring Beyond COVID-19: Setting Yourself Up for the New-Normal
Monitoring Beyond COVID-19: Setting Yourself Up for the New-NormalMontrium
 
Best Practices for Implementing Robust Governance Processes in Office 365
Best Practices for Implementing Robust Governance Processes in Office 365Best Practices for Implementing Robust Governance Processes in Office 365
Best Practices for Implementing Robust Governance Processes in Office 365Montrium
 
Strategies to Facilitate GxP Processes Deployment in Office 365
Strategies to Facilitate GxP Processes Deployment in Office 365Strategies to Facilitate GxP Processes Deployment in Office 365
Strategies to Facilitate GxP Processes Deployment in Office 365Montrium
 
How to Get Started with GxP Processes in Office 365 - The Discovery Phase
How to Get Started with GxP Processes in Office 365 - The Discovery PhaseHow to Get Started with GxP Processes in Office 365 - The Discovery Phase
How to Get Started with GxP Processes in Office 365 - The Discovery PhaseMontrium
 
How to prepare for an audit and maintain oversight within your e qms
How to prepare for an audit and maintain oversight within your e qmsHow to prepare for an audit and maintain oversight within your e qms
How to prepare for an audit and maintain oversight within your e qmsMontrium
 
Transforming eTMF Management: Moving to a Data-Driven Approach
Transforming eTMF Management: Moving to a Data-Driven ApproachTransforming eTMF Management: Moving to a Data-Driven Approach
Transforming eTMF Management: Moving to a Data-Driven ApproachMontrium
 
Best practices for preparing for and surviving inspections
Best practices for preparing for and surviving inspectionsBest practices for preparing for and surviving inspections
Best practices for preparing for and surviving inspectionsMontrium
 
Best practices for preparing for and surviving inspections
Best practices for preparing for and surviving inspectionsBest practices for preparing for and surviving inspections
Best practices for preparing for and surviving inspectionsMontrium
 
Implementing Metrics & Completeness Reporting in TMF Management​
Implementing Metrics & Completeness Reporting in TMF Management​Implementing Metrics & Completeness Reporting in TMF Management​
Implementing Metrics & Completeness Reporting in TMF Management​Montrium
 
Empowering Active TMF Management With an eTMF System
Empowering Active TMF Management With an eTMF SystemEmpowering Active TMF Management With an eTMF System
Empowering Active TMF Management With an eTMF SystemMontrium
 
Governance Strategies for Office 365
Governance Strategies for Office 365Governance Strategies for Office 365
Governance Strategies for Office 365Montrium
 
Empowering active tmf management
Empowering active tmf managementEmpowering active tmf management
Empowering active tmf managementMontrium
 
Automation of document management paul fenton webinar
Automation of document management paul fenton webinarAutomation of document management paul fenton webinar
Automation of document management paul fenton webinarMontrium
 
Continuous validation of office 365
Continuous validation of office 365Continuous validation of office 365
Continuous validation of office 365Montrium
 
Practical Steps to Selecting and Implementing an eTMF
Practical Steps to Selecting and Implementing an eTMFPractical Steps to Selecting and Implementing an eTMF
Practical Steps to Selecting and Implementing an eTMFMontrium
 
Tools for Accelerating Validation of Office 365
Tools for Accelerating Validation of Office 365Tools for Accelerating Validation of Office 365
Tools for Accelerating Validation of Office 365Montrium
 
Implementing the TMF Reference Model
Implementing the TMF Reference ModelImplementing the TMF Reference Model
Implementing the TMF Reference ModelMontrium
 
Tmf Fundamentals - webinar
Tmf Fundamentals - webinarTmf Fundamentals - webinar
Tmf Fundamentals - webinarMontrium
 
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...TMF Fundamentals - An Introduction to Better Trial Master File Management - M...
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...Montrium
 
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Montrium
 

Más de Montrium (20)

Monitoring Beyond COVID-19: Setting Yourself Up for the New-Normal
Monitoring Beyond COVID-19: Setting Yourself Up for the New-NormalMonitoring Beyond COVID-19: Setting Yourself Up for the New-Normal
Monitoring Beyond COVID-19: Setting Yourself Up for the New-Normal
 
Best Practices for Implementing Robust Governance Processes in Office 365
Best Practices for Implementing Robust Governance Processes in Office 365Best Practices for Implementing Robust Governance Processes in Office 365
Best Practices for Implementing Robust Governance Processes in Office 365
 
Strategies to Facilitate GxP Processes Deployment in Office 365
Strategies to Facilitate GxP Processes Deployment in Office 365Strategies to Facilitate GxP Processes Deployment in Office 365
Strategies to Facilitate GxP Processes Deployment in Office 365
 
How to Get Started with GxP Processes in Office 365 - The Discovery Phase
How to Get Started with GxP Processes in Office 365 - The Discovery PhaseHow to Get Started with GxP Processes in Office 365 - The Discovery Phase
How to Get Started with GxP Processes in Office 365 - The Discovery Phase
 
How to prepare for an audit and maintain oversight within your e qms
How to prepare for an audit and maintain oversight within your e qmsHow to prepare for an audit and maintain oversight within your e qms
How to prepare for an audit and maintain oversight within your e qms
 
Transforming eTMF Management: Moving to a Data-Driven Approach
Transforming eTMF Management: Moving to a Data-Driven ApproachTransforming eTMF Management: Moving to a Data-Driven Approach
Transforming eTMF Management: Moving to a Data-Driven Approach
 
Best practices for preparing for and surviving inspections
Best practices for preparing for and surviving inspectionsBest practices for preparing for and surviving inspections
Best practices for preparing for and surviving inspections
 
Best practices for preparing for and surviving inspections
Best practices for preparing for and surviving inspectionsBest practices for preparing for and surviving inspections
Best practices for preparing for and surviving inspections
 
Implementing Metrics & Completeness Reporting in TMF Management​
Implementing Metrics & Completeness Reporting in TMF Management​Implementing Metrics & Completeness Reporting in TMF Management​
Implementing Metrics & Completeness Reporting in TMF Management​
 
Empowering Active TMF Management With an eTMF System
Empowering Active TMF Management With an eTMF SystemEmpowering Active TMF Management With an eTMF System
Empowering Active TMF Management With an eTMF System
 
Governance Strategies for Office 365
Governance Strategies for Office 365Governance Strategies for Office 365
Governance Strategies for Office 365
 
Empowering active tmf management
Empowering active tmf managementEmpowering active tmf management
Empowering active tmf management
 
Automation of document management paul fenton webinar
Automation of document management paul fenton webinarAutomation of document management paul fenton webinar
Automation of document management paul fenton webinar
 
Continuous validation of office 365
Continuous validation of office 365Continuous validation of office 365
Continuous validation of office 365
 
Practical Steps to Selecting and Implementing an eTMF
Practical Steps to Selecting and Implementing an eTMFPractical Steps to Selecting and Implementing an eTMF
Practical Steps to Selecting and Implementing an eTMF
 
Tools for Accelerating Validation of Office 365
Tools for Accelerating Validation of Office 365Tools for Accelerating Validation of Office 365
Tools for Accelerating Validation of Office 365
 
Implementing the TMF Reference Model
Implementing the TMF Reference ModelImplementing the TMF Reference Model
Implementing the TMF Reference Model
 
Tmf Fundamentals - webinar
Tmf Fundamentals - webinarTmf Fundamentals - webinar
Tmf Fundamentals - webinar
 
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...TMF Fundamentals - An Introduction to Better Trial Master File Management - M...
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...
 
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...
 

Último

Short Story: Unveiling the Reasoning Abilities of Large Language Models by Ke...
Short Story: Unveiling the Reasoning Abilities of Large Language Models by Ke...Short Story: Unveiling the Reasoning Abilities of Large Language Models by Ke...
Short Story: Unveiling the Reasoning Abilities of Large Language Models by Ke...kellynguyen01
 
Hand gesture recognition PROJECT PPT.pptx
Hand gesture recognition PROJECT PPT.pptxHand gesture recognition PROJECT PPT.pptx
Hand gesture recognition PROJECT PPT.pptxbodapatigopi8531
 
Steps To Getting Up And Running Quickly With MyTimeClock Employee Scheduling ...
Steps To Getting Up And Running Quickly With MyTimeClock Employee Scheduling ...Steps To Getting Up And Running Quickly With MyTimeClock Employee Scheduling ...
Steps To Getting Up And Running Quickly With MyTimeClock Employee Scheduling ...MyIntelliSource, Inc.
 
Right Money Management App For Your Financial Goals
Right Money Management App For Your Financial GoalsRight Money Management App For Your Financial Goals
Right Money Management App For Your Financial GoalsJhone kinadey
 
Software Quality Assurance Interview Questions
Software Quality Assurance Interview QuestionsSoftware Quality Assurance Interview Questions
Software Quality Assurance Interview QuestionsArshad QA
 
The Ultimate Test Automation Guide_ Best Practices and Tips.pdf
The Ultimate Test Automation Guide_ Best Practices and Tips.pdfThe Ultimate Test Automation Guide_ Best Practices and Tips.pdf
The Ultimate Test Automation Guide_ Best Practices and Tips.pdfkalichargn70th171
 
TECUNIQUE: Success Stories: IT Service provider
TECUNIQUE: Success Stories: IT Service providerTECUNIQUE: Success Stories: IT Service provider
TECUNIQUE: Success Stories: IT Service providermohitmore19
 
HR Software Buyers Guide in 2024 - HRSoftware.com
HR Software Buyers Guide in 2024 - HRSoftware.comHR Software Buyers Guide in 2024 - HRSoftware.com
HR Software Buyers Guide in 2024 - HRSoftware.comFatema Valibhai
 
+971565801893>>SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHAB...
+971565801893>>SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHAB...+971565801893>>SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHAB...
+971565801893>>SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHAB...Health
 
CALL ON ➥8923113531 🔝Call Girls Kakori Lucknow best sexual service Online ☂️
CALL ON ➥8923113531 🔝Call Girls Kakori Lucknow best sexual service Online  ☂️CALL ON ➥8923113531 🔝Call Girls Kakori Lucknow best sexual service Online  ☂️
CALL ON ➥8923113531 🔝Call Girls Kakori Lucknow best sexual service Online ☂️anilsa9823
 
CALL ON ➥8923113531 🔝Call Girls Badshah Nagar Lucknow best Female service
CALL ON ➥8923113531 🔝Call Girls Badshah Nagar Lucknow best Female serviceCALL ON ➥8923113531 🔝Call Girls Badshah Nagar Lucknow best Female service
CALL ON ➥8923113531 🔝Call Girls Badshah Nagar Lucknow best Female serviceanilsa9823
 
Reassessing the Bedrock of Clinical Function Models: An Examination of Large ...
Reassessing the Bedrock of Clinical Function Models: An Examination of Large ...Reassessing the Bedrock of Clinical Function Models: An Examination of Large ...
Reassessing the Bedrock of Clinical Function Models: An Examination of Large ...harshavardhanraghave
 
Tech Tuesday-Harness the Power of Effective Resource Planning with OnePlan’s ...
Tech Tuesday-Harness the Power of Effective Resource Planning with OnePlan’s ...Tech Tuesday-Harness the Power of Effective Resource Planning with OnePlan’s ...
Tech Tuesday-Harness the Power of Effective Resource Planning with OnePlan’s ...OnePlan Solutions
 
Learn the Fundamentals of XCUITest Framework_ A Beginner's Guide.pdf
Learn the Fundamentals of XCUITest Framework_ A Beginner's Guide.pdfLearn the Fundamentals of XCUITest Framework_ A Beginner's Guide.pdf
Learn the Fundamentals of XCUITest Framework_ A Beginner's Guide.pdfkalichargn70th171
 
Optimizing AI for immediate response in Smart CCTV
Optimizing AI for immediate response in Smart CCTVOptimizing AI for immediate response in Smart CCTV
Optimizing AI for immediate response in Smart CCTVshikhaohhpro
 
Unveiling the Tech Salsa of LAMs with Janus in Real-Time Applications
Unveiling the Tech Salsa of LAMs with Janus in Real-Time ApplicationsUnveiling the Tech Salsa of LAMs with Janus in Real-Time Applications
Unveiling the Tech Salsa of LAMs with Janus in Real-Time ApplicationsAlberto González Trastoy
 
W01_panagenda_Navigating-the-Future-with-The-Hitchhikers-Guide-to-Notes-and-D...
W01_panagenda_Navigating-the-Future-with-The-Hitchhikers-Guide-to-Notes-and-D...W01_panagenda_Navigating-the-Future-with-The-Hitchhikers-Guide-to-Notes-and-D...
W01_panagenda_Navigating-the-Future-with-The-Hitchhikers-Guide-to-Notes-and-D...panagenda
 

Último (20)

Short Story: Unveiling the Reasoning Abilities of Large Language Models by Ke...
Short Story: Unveiling the Reasoning Abilities of Large Language Models by Ke...Short Story: Unveiling the Reasoning Abilities of Large Language Models by Ke...
Short Story: Unveiling the Reasoning Abilities of Large Language Models by Ke...
 
Hand gesture recognition PROJECT PPT.pptx
Hand gesture recognition PROJECT PPT.pptxHand gesture recognition PROJECT PPT.pptx
Hand gesture recognition PROJECT PPT.pptx
 
Steps To Getting Up And Running Quickly With MyTimeClock Employee Scheduling ...
Steps To Getting Up And Running Quickly With MyTimeClock Employee Scheduling ...Steps To Getting Up And Running Quickly With MyTimeClock Employee Scheduling ...
Steps To Getting Up And Running Quickly With MyTimeClock Employee Scheduling ...
 
Right Money Management App For Your Financial Goals
Right Money Management App For Your Financial GoalsRight Money Management App For Your Financial Goals
Right Money Management App For Your Financial Goals
 
CHEAP Call Girls in Pushp Vihar (-DELHI )🔝 9953056974🔝(=)/CALL GIRLS SERVICE
CHEAP Call Girls in Pushp Vihar (-DELHI )🔝 9953056974🔝(=)/CALL GIRLS SERVICECHEAP Call Girls in Pushp Vihar (-DELHI )🔝 9953056974🔝(=)/CALL GIRLS SERVICE
CHEAP Call Girls in Pushp Vihar (-DELHI )🔝 9953056974🔝(=)/CALL GIRLS SERVICE
 
Software Quality Assurance Interview Questions
Software Quality Assurance Interview QuestionsSoftware Quality Assurance Interview Questions
Software Quality Assurance Interview Questions
 
The Ultimate Test Automation Guide_ Best Practices and Tips.pdf
The Ultimate Test Automation Guide_ Best Practices and Tips.pdfThe Ultimate Test Automation Guide_ Best Practices and Tips.pdf
The Ultimate Test Automation Guide_ Best Practices and Tips.pdf
 
TECUNIQUE: Success Stories: IT Service provider
TECUNIQUE: Success Stories: IT Service providerTECUNIQUE: Success Stories: IT Service provider
TECUNIQUE: Success Stories: IT Service provider
 
HR Software Buyers Guide in 2024 - HRSoftware.com
HR Software Buyers Guide in 2024 - HRSoftware.comHR Software Buyers Guide in 2024 - HRSoftware.com
HR Software Buyers Guide in 2024 - HRSoftware.com
 
Microsoft AI Transformation Partner Playbook.pdf
Microsoft AI Transformation Partner Playbook.pdfMicrosoft AI Transformation Partner Playbook.pdf
Microsoft AI Transformation Partner Playbook.pdf
 
+971565801893>>SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHAB...
+971565801893>>SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHAB...+971565801893>>SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHAB...
+971565801893>>SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUDHAB...
 
CALL ON ➥8923113531 🔝Call Girls Kakori Lucknow best sexual service Online ☂️
CALL ON ➥8923113531 🔝Call Girls Kakori Lucknow best sexual service Online  ☂️CALL ON ➥8923113531 🔝Call Girls Kakori Lucknow best sexual service Online  ☂️
CALL ON ➥8923113531 🔝Call Girls Kakori Lucknow best sexual service Online ☂️
 
CALL ON ➥8923113531 🔝Call Girls Badshah Nagar Lucknow best Female service
CALL ON ➥8923113531 🔝Call Girls Badshah Nagar Lucknow best Female serviceCALL ON ➥8923113531 🔝Call Girls Badshah Nagar Lucknow best Female service
CALL ON ➥8923113531 🔝Call Girls Badshah Nagar Lucknow best Female service
 
Reassessing the Bedrock of Clinical Function Models: An Examination of Large ...
Reassessing the Bedrock of Clinical Function Models: An Examination of Large ...Reassessing the Bedrock of Clinical Function Models: An Examination of Large ...
Reassessing the Bedrock of Clinical Function Models: An Examination of Large ...
 
Tech Tuesday-Harness the Power of Effective Resource Planning with OnePlan’s ...
Tech Tuesday-Harness the Power of Effective Resource Planning with OnePlan’s ...Tech Tuesday-Harness the Power of Effective Resource Planning with OnePlan’s ...
Tech Tuesday-Harness the Power of Effective Resource Planning with OnePlan’s ...
 
Vip Call Girls Noida ➡️ Delhi ➡️ 9999965857 No Advance 24HRS Live
Vip Call Girls Noida ➡️ Delhi ➡️ 9999965857 No Advance 24HRS LiveVip Call Girls Noida ➡️ Delhi ➡️ 9999965857 No Advance 24HRS Live
Vip Call Girls Noida ➡️ Delhi ➡️ 9999965857 No Advance 24HRS Live
 
Learn the Fundamentals of XCUITest Framework_ A Beginner's Guide.pdf
Learn the Fundamentals of XCUITest Framework_ A Beginner's Guide.pdfLearn the Fundamentals of XCUITest Framework_ A Beginner's Guide.pdf
Learn the Fundamentals of XCUITest Framework_ A Beginner's Guide.pdf
 
Optimizing AI for immediate response in Smart CCTV
Optimizing AI for immediate response in Smart CCTVOptimizing AI for immediate response in Smart CCTV
Optimizing AI for immediate response in Smart CCTV
 
Unveiling the Tech Salsa of LAMs with Janus in Real-Time Applications
Unveiling the Tech Salsa of LAMs with Janus in Real-Time ApplicationsUnveiling the Tech Salsa of LAMs with Janus in Real-Time Applications
Unveiling the Tech Salsa of LAMs with Janus in Real-Time Applications
 
W01_panagenda_Navigating-the-Future-with-The-Hitchhikers-Guide-to-Notes-and-D...
W01_panagenda_Navigating-the-Future-with-The-Hitchhikers-Guide-to-Notes-and-D...W01_panagenda_Navigating-the-Future-with-The-Hitchhikers-Guide-to-Notes-and-D...
W01_panagenda_Navigating-the-Future-with-The-Hitchhikers-Guide-to-Notes-and-D...
 

10 Benefits TMF Managers are Achieving with eTMF Systems

  • 1. 10 Benefits TMF Managers are Achieving with eTMF Systems
  • 2.  Track status of TMF content documents: completed, filed, or missing  Verify status in real-time from any location  Access tools, such as reports and data exportation Benefit 1 | Real-Time Tracking & Viewing of Documents © 2017 All Rights Reserved.
  • 3. Benefit 2 | Easier to Search & Find Documents  Create and upload documents directly in the system  Search documents based on metadata and content  Organize documents on pre-defined TMF structure  Easily locate, retrieve, and view specific documents © 2017 All Rights Reserved.
  • 4.  Increase speed of Study Start-Up  Provides central location for information and documentation; always up- to-date with the latest versions  Improves collaboration between trial stakeholders and clinical teams  Pre-defined templates for document creation  Increase speed of Study Close-Out  Progressive and continuous compilation of TMF; no end of study rush  Continuous quality control of documents Benefit 3 | Shortened Clinical Trial Time © 2017 All Rights Reserved.
  • 5.  Simplify communications, process, and collaboration with IRBs and IECs  Provide access to specific documents and create IRB/IEC portals Benefit 4 | Easier Collaboration with IRBs/IECs © 2017 All Rights Reserved.
  • 6.  Tracking & Accountability of TMF Content  Track when the reception, review, quality control, and filing take place Benefit 5 | Increase TMF SOP Compliance  Timeliness of TMF Compilation  Identifies required documentation; dividing them into expected and outstanding documentation © 2017 All Rights Reserved.
  • 7.  Extract key business intelligence from documents in the system  Embedded analytics for better decision making Benefit 6 | Better Visibility into Key Trial Performance Metrics © 2017 All Rights Reserved.
  • 8.  Eliminates costs associated with paper document storage  Eliminates costs associated with managing snail mail, scanning, filing & refiling, and retrieving documents Benefit 7 | Cost Savings © 2017 All Rights Reserved.
  • 9. Our customizable Paper-Based System Cost Calculator lets you input a few basic metrics and tells you all the information you need to know! Ever wonder how much your paper system is actually costing you? Free Download © 2017 All Rights Reserved.
  • 10.  Eliminates document overlap  Document versions are always up-to- date and easily accessible  Simplified TMF compilation Benefit 8 | Easier Collaboration with Sites
  • 11.  Allows all records, documents, and information to be available and accessible  Ensures documents have undergone formal quality control  Provides tools for filtered view to facilitate inspection  Reports generated by system indicate what is required for inspection and what needs to be completed Benefit 9 | Improved Audit & Inspection Readiness © 2017 All Rights Reserved.
  • 12.  All TMF content in one electronic location, meaning no need to physically transfer paper documents  Eliminates overhead costs associated with the shipment of documents  All pertinent information located in central location Benefit 10 | Easier Collaboration with CROs © 2017 All Rights Reserved.
  • 13. The Future of eTMF Convergence of Clinical Data  Combination of documents and data from ancillary systems  Integration and connection of information sources to eliminate information silos  Improved collaboration and tracking information sharing between sponsors, CROs and clinical sites © 2017 All Rights Reserved.
  • 14. Key Takeaways  Improved and simplified collaboration between sponsors, CROs, and clinical sites  All content in one central location; always accessible and always up-to-date  All content is tracked and given a status  Improved quality control and compliance  Always inspection ready  Cost savings due to the elimination of paper documents © 2017 All Rights Reserved.
  • 15. www.montrium.com © 2017 Montrium. All Rights Reserved. 15 The Smart Way to Manage TMF Content CLICK TO EXPLORE © 2017 All Rights Reserved.
  • 16. Key Features eTMF Connect Complete eTMF Configuration based on TMF RM Automatic Classification of Artifacts Configurable & Intuitive Workflows Clinical Inbox for External Documents Bath Indexing & Auto- filing of Records eTMF Navigator © 2017 All Rights Reserved.

Notas del editor

  1. The Smart way to manage TMF Content