Slide 1: Veeva
Veeva
Slide 2: 19R2 Release Webinar
19R2 Release Webinar New Features July 17, 2019 Please use ‘Q&A’ to ask a question
Slide 3: Sharon Lin
Sharon Lin Principal Product Manager, Vault CDMS
Slide 4: CDMS Product Team
CDMS Product Team Tony Tsai Dennis Kochanski Senior Product Manager, Senior Product Manager, Vault CDMS Vault CDMS Mohammed Al-Adeeb Rakesh Monassery Senior Product Manager, Senior Product Manager, Vault CDMS Vault CDMS Quentin Paresys Product Manager, Vault CDMS Copyright © Veeva Systems 2019 4
Slide 5: Important Disclosures
Important Disclosures The following is intended to outline Veeva’s general product direction. It is intended for informational purposes only and does not form part of any contract. It is not a commitment to deliver any specific functionality and it should not be relied upon in making purchasing deci
Slide 6: Foreword
Foreword • The content of this presentation is subject to change prior to the 19R2 Release Please note the date on the title slide • Veeva encourages you to always reference Release documentation from our Release pages to ensure you are using the latest information Help Release Notes About the 1
Slide 7: Interact With Us!
Interact With Us! Copyright © Veeva Systems 2019 7
Slide 8: Reinventing Clinical Data Management
Reinventing Clinical Data Management ePRO Labs Vault Coder Vault EDC Vault Data Workbench* Randomization Clinical Coding Data Capture & Monitoring Cleaning & Reporting API Queries Imaging Data Translation Data Lake Biomarker CRO, Other.. *Vault Data Workbench is currently under development Copyright
Slide 9: Veeva Vault Release Schedule
Veeva Vault Release Schedule 19R3 Jan Feb Dec Nov Mar 2019 Oct CDMS Product Apr 19R1 Release Strategy Sep May Aug Jun Jul 19R2 Copyright © Veeva Systems 2019 9
Slide 10: 19R2 Release Calendar
19R2 Release Calendar Sun Mon Tue Wed Thu Fri Sat 14 15 16 17 18 19 20 19R2 Release webinar 21 22 23 24 25 26 27 19R2 Pre - Release Validation Docs 28 29 30 31 1 2 3 AUG 4 5 6 7 8 9 10 19R2 General Release Customer Validation Copyright © Veeva Systems 2019 10
Slide 11: Pre-Release Environment
Pre-Release Environment tre-release https://login.veevavault.com JULY • Clone of Production and UAT • Data and Configuration is copied Monday • Users are not copied 22nd • Contact Veeva Project Manager to add users • Available up to 4 weeks after the 19R2 upgrade Copyright © Veeva Systems 2019 11
Slide 12: Validation Documents
Validation Documents • Validation Project Plan JULY • IOQ Protocols • Business Requirements Documents Tuesday • Traceability Matrixes 23rd • System Release Memo • Summary Reports • Executed OQ Scripts (unexecuted in Word format available upon request) Copyright © Veeva Systems 2019 12
Slide 13: 19R2 Go Live
19R2 Go Live • ALL customer vaults upgraded to 19R2 AUGUST • EU starts at 2:00pm PT • APAC & US starts at 5:00 PM PT Friday • May take up to 6 hours 9th Copyright © Veeva Systems 2019 13
Slide 14: 19R2 General Release Resources
19R2 General Release Resources • Resources Available • https://cdmshelp.veeva.com/pr/rn/general-release/19r2/ − Important Dates − Pre-Release FAQ − Release Impact Assessment − What’s new in 19R2 − Feature Enablement Details Copyright © Veeva Systems 2019 14
Slide 15: Agenda
Agenda WEDNESDAY, JULY 17 CDMS Investments 19R2 Feature Value Add Site Demo CRA and Data Manager Demo Coder Demo Q&A Copyright © Veeva Systems 2019 15
Slide 16: 19R2 Investments
19R2 Investments Investments were made to advance the CDMS application Sites CRAs and Data Managers Coding Admin Study Designer Foundation • Casebook • Last Event/Next • Select/De-Select All • Review Plan • Coding • Clinical Assessments Confirmation Event • Query Status Filter Assignment Configurati
Slide 17: 19R2 Feature Value Add
19R2 Feature Value Add Optimized User Experience Sites Tabular Data View Review Latest casebook version, Event Tree view with synchs with right form details, Previous Event/Next Event, Increased modal box, new Icons, Form Level Reviews Coding Coding: Select/De-select all checkboxes, Summary view exp
Slide 18: 19R2 Feature Value Add (cont’d)
19R2 Feature Value Add (cont’d) Simplified User Role Admin Custom Study Role Management Management Instantaneous Study Changes Admin Retrospective Amendments • Event (Visit) changes • Changes to Max/Min of Item Groups • Unknown Date/Time Subject Transfers Faster Site Setup Admin Bulk Import Sites Fa
Slide 19: 19R2 CDMS Features by Users
19R2 CDMS Features by Users Sites CRAs and Data Managers Coding Admin Study Designer Data Entry Tab Review Tab Coding Tab EDC Tools Studio Tab Copyright © Veeva Systems 2019 19
Slide 20: Feature Enablement Detail
Feature Enablement Detail Auto-On Features Configurable Features Auto-On Configuration Support Turned On Day 1 Turned Off Turned Off Automatically Requires Requires available enablement enablement Requires Product Support configuration Request Copyright © Veeva Systems 2019 20
Slide 21: Sites
V Sites
Slide 22: Casebook Confirmation
Casebook Confirmation Automatic • Overview Users will be asked to confirm if they want to create a casebook. • Business Value Sites were accidentally creating casebooks, and this will help minimize the casebooks created in error. Feature Risk LOW Default Impact VISIBLE TO ALL USERS Copyright © Veeva
Slide 23: Delete Subjects
Delete Subjects Configurable • Overview Users will be able to delete subjects if they were granted permission • Business Value This will give users the authority to correct any mistakes with erroneous subjects • Consideration − Subject must contain no data. If there is data, data must be deleted (fo
Slide 24: Allow Unknown Time
Allow Unknown Time Configurable • Overview Users can now enter a “?” in the time field for date/time field when configured to support as unknown • Business Value Patients do not remember the time when the headache occurred and instead of requiring a time a “?” can be entered, and instead of them mak
Slide 25: Tabular Data View
Tabular Data View Configurable • Overview Users can now view data in a tabular (column/row) format for repeating item groups. • Business Value There are certain form views that are better displayed in a tabular view, this may be a log of events that has occurred like Medical History and Physical Exa
Slide 26: Site Demo
DEMO Site Demo Copyright © Veeva Systems 2019 26
Slide 27: CRAs/Data Manager
V CRAs/Data Manager
Slide 28: Accessible Data
Accessible Data Automatic • Overview New columns were added to the Review Subject Listings page – Last Event and Next Event. Casebook versions have been added • Business Value This provides a quick and easy way to access relevant data. Feature Risk LOW Default Impact VISIBLE TO ALL USERS Copyright ©
Slide 29: Enhanced User Experience
Enhanced User Experience Automatic • Overview Tree Visits and Forms is highlighted and synched with Right Pane Form Details. Form level Reviews Icon changes View as Site window screen has increased to a larger view • Business Value Improve the quality of the Reviewer’s interaction with the applicati
Slide 30: Save Button
Save Button Automatic • Overview Any changes made to the SDV/DMR must be saved. Any changes made to SDV/DMR that are unsaved are indicated with a yellow background. • Business Value This ensures consistency in the Rollup status (left nav) when users are clicking review checkboxes too fast. Feature R
Slide 31: Review Tab designed for CRAs/Data Manager
Review Tab designed for CRAs/Data Manager CRAs and Data Managers Sites Data Entry Tab VS Review Tab • Comprehensive View focusing on • Designed for Site Data Entry Reviews • Quick and Easy Navigation to view • Multiple Clicks to Review Visits/ Visit/ Forms Forms • Centralized location of all Queries
Slide 32: CRA and Data Manager Demo
DEMO CRA and Data Manager Demo Copyright © Veeva Systems 2019 32
Slide 33: Coding
V Coding
Slide 34: Enhanced User Experience
Enhanced User Experience Automatic • Overview Coders can select or deselect all coding items in the Coding Listings Panel Summary is exposed through an icon • Business Value Having a select/de-select all makes it easier for user to select a lot of coding items at once instead of clicking multiple ti
Slide 35: Query Status Filter
Query Status Filter Automatic • Overview Coders will be able to filter based on the different query statuses • Business Value Coder can stay focused with the task at hand and choose to see only open queries, or only responded queries. Feature Risk LOW Default Impact VISIBLE TO ALL USERS Copyright ©
Slide 36: Dictionary Search Efficiencies
Dictionary Search Efficiencies AUTOMATIC • Overview Search results that may contain the same drug name but diff preferred names will appear ”together” on the top of the search results. Search up to 10 key words Supports Special ASCII characters • Business Value CODING Coders will gain efficiencies b
Slide 37: Dashboard
Dashboard Support • Overview Coding dashboard that provides a overall review of the Coding progress • Business Value Comprehensive, graphical Visualization of Coding status and progress CODING Feature Risk LOW Default Impact None Copyright © Veeva Systems 2019 37
Slide 38: Unique Term Report
Unique Term Report Support • Overview The Unique term report contains all the unique coded terms. • Business Value This allows Coding Manager to focus on new coding patterns and history of coding. Feature Risk LOW Default Impact None Copyright © Veeva Systems 2019 38
Slide 39: Unique Terms Report
1. Select a Date Range Unique Terms Report 2. If new coding assignment is only available in the Date Range, will be flagged for 3. Blank column for 2. Record count for the review. comments to track and coding assignment. share Copyright © Veeva Systems 2019 39
Slide 40: Coding Demo
DEMO Coding Demo Copyright © Veeva Systems 2019 40
Slide 41: Questions
2 Questions
Slide 42: Thank You
Thank You Thank you