Clinical Data Lifecycle Management:

Key business challenges to be addressed (non-exhaustive)

Data Capture Data Archive

Design Setup Data Clean Reporting

Data Analysis Data Reuse

Cleaning / extracting to a clinical cut off

Tracking the location and status of all data

No system holds the definitive time and events source

Too many systems, poor integration, and the overall environment is too complex

Processes are manually intensive and inefficient – leverage standards, technology & automation

Delivering in-stream data and analysis is problematic

Data quality expectations (esp. at DBR) are not being met

Systems cannot predictably handle large data volumes

Data consolidation and reuse are difficult

Image data cannot be viewed and integrated with GSK

Medical coding process is inefficient

There are several process and technology challenges that need to be addressed
 Clinical Data Lifecycle Management:
External drivers impacting process

Data Capture Data Archive

Design Setup Data Clean Reporting

Data Analysis Data Reuse

CDISC

HL7

PDUFA IV

Non Traditional Trial Designs, Feasibility Assessment / Rapid Trials

EHR
 Clinical Data Lifecycle Management:
Emerging technologies that may have application

Data Capture Data Archive

Design Setup Data Clean Reporting

Data Analysis Data Reuse

Lifecycle management tools (LSH, SDD, etc)

eProtocol / Autogenesis Imaging & other new types of data e.g. PGX

ePRO

EHR

SOA (general)
 Clinical Data Lifecycle Management:
Current major IT projects versus process

Data Capture Data Archive

Design Setup Data Clean Reporting

Data Analysis Data Reuse

IDME: SSDME

iNet

IDME: Data Tracker

IDME: Data Visualisation

Inform 4.6 upgrades

HARP 3.0 upgrades

SAS v9
 Clinical Data Flow Strategy Programme Plans V9 25 Feb 2009

2009 2010 2011 2012

Clinical Data Flow Implementation
ID
Strategy Projects Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun

1st study report / submission All new studies using

1st study start
Study & Streamlined flow modular document sets
Asset of information Create reusable document set
1 Content between CD plans for early CD plans for late CD plans integrated Pilot complete, potential
Generation documents and 1st study report
study design phase studies phase studies with iPlan and eTrack for automation proved. 1st study start
& Flow
Integrated CD Plans Automate re-use of study protocol content (Align with As-IS & To Be slide)

Inform 4.6 Strategy for eDC/eDM sourcing & All new studies start in
Implementation plan 1st study close
Investigate and planning
pilot optimal eDC / eDM optimal environment
Insight 4.1 - subject enrollment
environment
Subject Data Tracker Implement optimal eDC / eDM environment

Investigator Investigator Portal

Workshop
Simplify Duplicate data entry reduced Duplicate data entry eliminated eTrack 2.2
Investigator and (NTSD support)
2 Integrate eDC, CTMS & IVR
Study Team Integrate all investigator facing systems (Q3 2012)
Experience
eTrack 2.0 - Investigator eTrack 2.1 - Integration &
eTrack 1.x Management, Simplification & Quality Productivity
Data Collection eTrack 2.x
and
Strategy endorsed? Implementation milestone? Implementation complete?
Flow Management
RAMOS replacement

Seamless Data Seamless exchange of Seamless exchange

Inlicensing Transfer, Tracking and Storage
3 Exchange with CDISC compliant data of non standard data
Partners Optimise GSK interface with 3rd party collaborations and partners

ICDS Tech Refresh eT&E for early phase eT&E for late phase
Central Designer studies studies
Electronic Time and Events
All study data available in CDISC standard formats
CDISC: Implement metadata driven solutions for standards management, transformation, and communication
Enabling industry
4
standard 1st studies converted to CDISC for submission Respiratory “Horizon” project
submissions submitted to CDISC standards
CDISC: Implement compliant analysis and reporting capability

1st study start based of CDISC compliant standards All new studies based on CDISC compliant standards
CDISC: Implement compliant study data capture capability

Definitive catalog of clinical data for all GSK assets

Information Create clinical meta data database
Repository, Aggregated database available for all key assets
Aggregated database for two Non clinical data integrated
Reporting & iNet Enhanced Data Loading
assets available. for two assets Non clinical data integrated for all key assets
Exchange
Implement repository for clinical data
Information
5 Improved regulatory response
Analysis in Minutes Data Visibility Improved regulatory response for 1st two assets
for all key assets
Repository analysis and information/query management
Full internal visibility of clinical data
Controlled external
and information on key assets
visibility
Progressive disclosure of data through integrated reporting environment

Information Information Strategy and Solution Integration - Champion Simplification

Strategy, Solution
Simpler Systems Vendor Management
6 Integration and Landscape
Change Change Management
Management Manage migration and decommissioning
Capital £6.5M £19.5M £26.4M £28.3M
7 Spend profile Net Revenue £2.5M £10.2M £18.8M £20.1M
Total Benefit £0M £5.6M £23.9M £38.3M