VEEVA VAULT SELECTION & IMPLEMENTATION...Implementation Overview Processes being redesigned System...

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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

Project Background

Sponsor or Service Provider: Sound Familiar?

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

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

Sponsor( CRO(

Protocols Study

Reports Clinical

Summaries

Labels

Nonclinical Summaries

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

Sponsor( CRO(

Complicating Factors

Sponsor( CRO(

Partner(Service(Provider(

Service(Provider(

Partner(Service(Provider(

Service(Provider(

Partner(

Sponsor(

Partner(

Partner(Sponsor(

Make this bridge: - Seamless, transparent, scalable, efficient - Repeatable…

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

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► Update/replace un-supported and outdated technology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

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

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

Medium

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

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

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

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

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

Assess Results against Targeted Outcomes (Throughout 2015)

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

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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