veeva vault selection & implementation...implementation overview processes being redesigned...
TRANSCRIPT
Copyright © 2014 Covance. All Rights Reserved
VEEVA VAULT SELECTION & IMPLEMENTATION: SUPPORTING MULTIPLE CRO-SPONSOR ENGAGEMENTS
2014 Veeva R&D Summit Philadelphia, PA
October 21, 2014
Harry Graham Business Operations Director
Global Regulatory Affairs
Agenda
► Project background
► Selection process
► Implementation experience
► What’s ahead
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Project Background
Sponsor or Service Provider: Sound Familiar?
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Increase(capabili-es(
Reduce(costs(
Shorten(cycle(-me(
Improve(quality(
Use(technology((more(efficiently(
Be(more(collabora-ve(
Add(services(
Accommodate(growth(
The Business Requirement
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Sponsor( CRO(• Overall'product'development'• Improved'trial'execu3on'and'registra3on'management'
• More'products'
• Right'service,'right'3me,'right'cost'• Improved'sponsor'rela3onship'• More'sponsors'
Focus on the Work
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Sponsor( CRO(
Protocols Study
Reports Clinical
Summaries
Labels
Nonclinical Summaries
CMC
Marketing Applications
Agency Correspondence
Development Plans
Trial Applications
Status and Progress Reports
Registration Maintenance
• Overall'product'development'• Improved'trial'execu3on'and'
registra3on'management'• More'products'
• Right'service,'right'3me,'right'cost'• Improved'sponsor'rela3onship'• More'sponsors'
The High Level Challenge
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Sponsor( CRO(
Complicating Factors
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Sponsor( CRO(
Partner(Service(Provider(
Service(Provider(
Partner(Service(Provider(
Service(Provider(
Partner(
Sponsor(
Sponsor(
Partner(
Partner(Sponsor(
Make this bridge: - Seamless, transparent, scalable, efficient - Repeatable…
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Selection Process
Late 2013
Conducted an assessment of regulatory affairs capabilities and business direction ► Continued increase in
number of studies ► Increased demand
for functional sourcing support
Reviewed technical support of regulatory affairs ► Internal processes ► Sponsor interactions
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Assessment Outcomes
Opportunities
► Consolidation of reviewer comments ► Content Collaboration
! Sponsor to CRO ! Intra-CRO
– Between authors – Authors and submission/publishing
! CRO to Sponsor – Reviews, comments – Final content
Requirements
► Update/replace un-supported and outdated technology
► Align with new technology | Veeva R&D Summit October 2014 11
Vendor Assessment
► Strategic view of vendor ► Implementation approach ► Usability and interface ► Process support
! Develop ! Review ! Approve
► Reporting and tracking ► Integration/interaction ► Migration ► Technical design ► Multi-tenancy
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Selection – Vault Submissions
► Key differentiators ! Configuration timing
– Out-of-the-box – Configure not customize
! Access and user management ! Usability/interface ! Technical design and operations ! Global support of many sponsors, many sizes of
sponsors ! Infrastructure costs
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Implementation Experience (a work in progress…)
High-Level Implementation Goals
► Focus on standards wherever possible ► Leverage out-of-the-box… and refine only
where necessary ► Enable and refine collaboration processes
! Word’s track changes ! Vault (PDF) annotations ! Support client-driven needs:
– Number of reviews – Compilation of comments
► Increase visibility and improve ability to measure operations
ALIGN AND BALANCE INTERNAL AND SPONSOR NEEDS
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Small
Medium
Large
Content Development
Content exchange
Content Management
Submission Management
Publishing
Metrics
Implementation Overview
► Processes being redesigned
► System ownership assigned ! Business administration ! System administration
► Workshops in progress
► Go-live in Jan 2015
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Internal Regulatory
Affairs
Internal Doc Mgmt
Internal and partner
Internal and client
Internal and client/partner
vaults
Client Access
► Longer-term goal is to enable direct client access
► Short-term need is to implement and on-board Covance users
1. Internal Change Management strategy 2. Move away from non-supported technology
► Externalizing Vault 1. Create “golden master” from which client-
specific Vaults are cloned, or 2. Use enhanced security (in a future release) to
open Covance Vault to clients
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Configuration Updates
► Document Types ! Non-submission docs: Regulatory strategy,
submission plans, gap analyses
! Expand Regulatory administrative docs to cover additional countries
► Binders ! Added approximately 10 templates: e.g. IND,
CTA, MAA ! Veeva creating ‘master’ binder templates during
implementation ! Covance will subsequently create country-specific
binders
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Configuration Updates (continued)
► Objects ! Added Sponsor object which is required on every
document ! Currently selecting both Sponsor and Product
(independently) for now ! Feature request submitted to enable “many to many”
relationships
► Workflows ! Added a QC workflow to process documents received
from external sources ! Added Sponsor Review workflow to identify documents
that have been sent to the Sponsor for review
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What’s ahead?
Key Activities
► Complete configurations ► Migrate approximately 500k documents
! Approximately 75% from legacy DCTM system ► Design and configure Reports & Dashboards
! Monitor status of client documents ! Report on key process metrics
► Initial Go-Live in January ► Ramp up user base between January and May
► 1H ‘15 - make decision regarding appropriate time to externalize Vault access
► 2H ‘15 – implement external access
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Assess Results against Targeted Outcomes (Throughout 2015)
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More bridges, with more capabilities and opportunities
Improved sponsor oversight, visibility to progress Improved abilities
to exchange content
Reduced level of effort in content
development Heavy leverage of reports, tracking,
dashboards
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Thank You!
Harry Graham Business Operations Director Global Regulatory Affairs email: [email protected] office: +1-609-452-4605 cell: +1-609-216-2726