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  • 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

    | Veeva R&D Summit October 2014 2

  • | Veeva R&D Summit October 2014 3

    Project Background

  • Sponsor or Service Provider: Sound Familiar?

    | Veeva R&D Summit October 2014 4

    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

    | Veeva R&D Summit October 2014 5

    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

    | Veeva R&D Summit October 2014 6

    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

    | Veeva R&D Summit October 2014 7

    Sponsor( CRO(

  • Complicating Factors

    | Veeva R&D Summit October 2014 8

    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…

  • | Veeva R&D Summit October 2014 9

    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

    | Veeva R&D Summit October 2014 10

  • 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

    | Veeva R&D Summit October 2014 12

  • 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

    | Veeva R&D Summit October 2014 13

  • | Veeva R&D Summit October 2014 14

    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

    | Veeva R&D Summit October 2014 15

    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

    | Veeva R&D Summit October 2014 16

    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

    | Veeva R&D Summit October 2014 17

  • 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

    | Veeva R&D Summit October 2014 18

  • 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

    | Veeva R&D Summit October 2014 19

  • | Veeva R&D Summit October 2014 20

    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

    | Veeva R&D Summit October 2014 21

  • Assess Results against Targeted Outcomes (Throughout 2015)

    | Veeva R&D Summit October 2014 22

    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

  • | Veeva R&D Summit October 2014 23

    Thank You!

    Harry Graham Business Operations Director Global Regulatory Affairs email: harry.graham@covance.com office: +1-609-452-4605 cell: +1-609-216-2726

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