introduction of new standards and governance...
TRANSCRIPT
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 2
Agenda
Short Introduction to NNIT
The Pharmaceutical Business Segment
Architectures in Clinical Development
NNIT Process Vision
Case Story – Introducing New Standards & Governance
The Approach
Governance & OCM
Conclusion
Questions
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 3
Short Introduction to NNIT
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 4
How does NNIT fit into the IT world?
LOCAL
INTERNATIONAL
CONSULTANCY SUPPLIER
Large international producers of software and/or hardware
Traditional large international IT consultancies
Local, Danish or Scandinavian niche producers of software and/or hardware
Local, Danish or Scandinavian IT consultancies
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 5
TOGAF9 is the foundation - relation to NNIT‟s offerings
Enterprise business processes
Map processes to systems
Enterprise business processes
Workflow architecture
Organisational strategy
Middleware & scheduling architecture
Gap analysis
Application principles Transition architecture
Capability assessment
Implementation governance model
Scoping
Compliance assessment
Risk management
Development and deployment guidance
Project estimation and planning
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 6
The Pharmaceutical Business Segment
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 7
The pharmaceutical segment
The Financial Crisis poses great challenges for all industries. Further pharma specific issues include:
Declining productivity of research & development
Long Development Timelines
Regulatory Compliance
General Risk Adverseness
Generic competition – as patents run out on Blockbusters
Uncertain future reimbursement for new products and technologies
Poor public opinion towards the industry
“Global pharmaceutical sales are expected to reach $1.1 trillion in 2014” (Reuters)
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 8
Architectures in Clinical Development
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 9
Is Clinical Development Special??
Methods for Determining Vaccine Efficacy and Effectiveness and the Main Barriers to Developing a Fully Deployable Malaria Vaccine Caterina Guinovart* and Pedro L. Alonso, NCBI
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 10
Business Architecture (Level 2)
SITE INVENTORY MANAGEMENT
Res. MgtDBRLPLV
PROTOCOL DEVELOPMENT
Final CDP Final Protocol
RECRUITMENT STRATEGY
STATISTICAL DATA HANDLING & ANALYSIS
MONITORING
DATA ADMINISTRATION
CDP DEVELOPMENT
SITE SELECTION &INITIATION
Initiate site
selection *3
TRIAL PRODUCT DESIGN
Final Site
Selection
Technology
Provisioning
HA/EC
submission /
approval
Investigator /
monitor
meeting
EDC Training
3* Assessment of:a. Investigator & Staffb. Resources at sitec. Of patient pop. and recruit. strategyd. Of laboratory facilities Assessment ofe. EDCf. Infrastructureg. Payment / budgeth. Regulatory requirements & ethics
5*a. Trial site & staff assessmentb. Review subject status & recruitmentc. Adverse Event review & follow-upd. Review protocol adherence / Review entered CRF Datae. Review informed consent proceduref. Disc. review, correction & handlingg. Assess supplies & storage conditionh. Perform drug accountabilityi. Review laboratory proceduresj. Check investigator trial filek. Perform SDV
1*Update IMPACT databaseInput to EudraCT databasePrepare in-house agreement
4*Revied Entered CRF dataReview Subject status & recruitmentDiscrepency Review
2*StudygroupInt. Study GroupInvestigators
IVRS Training
Site Initiation
REPORTING
Initiate
programming
and validation
Stat. analysis
(Simulated)
Stat. analysis
(blinded)
Initiate SAP
Evaluate and
provide feed-back
to SAP (EOT)
EOT based on
simulated data
Stat. analysis
(un-blinded)
Results
MeetingICTR
Publication
EOT (Tables,
Figures, Listings)
Submission
datasets
Exploratory
results
Explore, visualize and drill down in
data
SUBJECT & DRUG MANAGEMENT
Drug
DispensingDrug Returns
Screen Failure
RandomizationDrug
Reconciliation
NO
PATIENT RECRUITMENT
Subject
Screening
Manage / modify
recruitment strategy
Action
required ?
Monitor
Recruitment
No Action
VALIDATION PLAN & TRIAL SET-UP
Define TVP review
process and
validation strategyCreate TVP
Create
Database/
eCRF
Prioritize all
checks
Approve TVP
TVP
Setup Standard
& Trial specific
validation
Annotation
reviewProduce
Annotation
User
Acceptance
test
Annotations
Generate
simulated data
(optional)
Transfer
blinded data
Transfer un-
blinded data
Prepare statistical
analysis instance
for final run
IVRS SET-UP
Draft IVRS
URS
Vendor
specifications
Vendor Build
& Validates
System Test
System Go
Live
Protocol
Design
Research
1st draft of
protocol *1
Peer Review
(checklist) &
SG review *2
Second draft
of protocolISG Review
Final Draft
Identify CROs QC Check
Prepere,
Review and
Finalise CDP
Final Dose
Form
Final Pack
Design
Label
Approval
INVESTIGATIONAL PRODUCT PRODUCTION
Calculate Bulk
Forecast
Optain CDP /
Protocol
Calculate
Packaged
forecast
Manufacture
Packaged
Product
Manufacture
Bulk
Source
Comparators
Label product
WAREHOUSE / DEPOT INVENTORY MGMTRaise Drug
Shipment
Request
Check
Warehouse
Inventory
stock level
below
trigger?
Packaged
stock
available?
No
Yes Pick, Pack
and Ship
Raise Drug
Shipment
Request
Check Site
Inventory
Pick, Pack
and Ship
Is stock
level below
trigger ?
Yes
CDP Design
Research
Define
Milestones
TRIAL & RESOURCE MANAGEMENT
Demand
setting
Ressource
Supply
Project
Review
Portfolio
review
Time
Reporting
FTE & Cost
follow-up
Adjustment of
templates
EOT based on
”fake” randomized
data
Evaluate and
provide feed-back
to SAP (EOT)
Write, review and
approve ICTR or
publication
Request
eCRFs for
D&D cases
Generate
eCRF for D&D
Include
eCRFs in
Submission
Define and
Enter Trial
Meta data
No
Yes
Yes
NO
DATA ENTRY & VALIDATION
Contact Site
CRF Ddata
Lock
Evaluate +
Plan Visit *4
Conduct Site
Visit *5
Protocol
deviation form
Corrective
action
required?
Site Visit
Required
Document Site
Visit &
Deviations
Follow up after
site visitNO
NO
Yes
Yes
SITE CLOSURE
Send to Ethics
Committees
Final Protocol
Enter eCRF
data
Enter SAE
data
Load External
Data
Manage online
edit checks
Manage off-line
validations
Execute /
Manage Manual
checks
Medical coding
C
Stock / Site
inventory
Create
electronic
CRF Archives
Close Study
Site
PRC
Send to Local
Health
Authorities
Send Protocol
to affiliates
Revise Trial
Data Set-upA
Green Light
A&BA A
DATABASE RELEASE
Sign Database
release
DBR
Meeting
SAE
Reconsiliation
DATA REVIEWConduct data
review (ITM,
DM, Stats,
MW) Alert Data
ManagementUnlock data
Plan Data
Review
Data Issues
Review
Protocol
deviationsNO
YesC
Plan DBR
Assign
Subjects to trial
populations
Database/
eCRF
Map to CDW
Prepare pCRF for
AE and pregnancy
follow-up
If applicable. Provide
pCRFs for AE and
pregnancy follow-up
Un-blinding
Review eCRF
1st request for
essential documents
for ICTR
2nd request for
essential documents
for ICTR
Trial Set-up
(Impact)
Initiate statistical
data handling &
decisions
Transfer Data
B
Close IVRS
Finalise
programming
and validation
Finalise statistical
data handling &
decisions
Final
SAP
Protocol / Planning (456 & 589) Forecasting / Ordering (456) Packaging Packaging Synopsis Distribution Specifications Distribution Shipping Order Trial Master File
Trial Management
Ongoing Resource allocation
Global
recruitment
strategy
Country
recruitment
strategy
Regional
recruitment
strategy
Site
recruitment
strategy
Final ICTR
Withdrawels
FPFV
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 11
Segmentation across the entire landscape
= GxP-validated systems
= Non-GxP systems
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 12
Organisational Architecture (Roles & Depts) Tasks
1. Prepare CDP
2. Prepare Investigators Brochure
3. Prepare protocols
5. Site Initiation
6. Patient Recruit-ment
7. Treatment period
8. Conduct data manage-ment
9. Conduct Statistical Analysis
10. Prepare ICTR
11. Prepare reports and publica-tions
Draft CDP available
Final CDP available Draft protocol available
Final protocol available First subject in
Last subject in
Last subject out Database release
Analysis complete
Reports complete
Project plan, resource demand and supply
Time reporting, analysis and reporting
4. Prepare data management / statistical analysis
People & Skills
Culture and Behaviour
CSO /
CSCo /
IVRS
Designer
LTM /
Monitor /
Site support
Investigator
/ Site personnel
DM
Stat
Medical
Writer
Key changes in Department interfaces
Forecasting (Project 2)
Formal clinical supply strategy
IVRS decision tree / mngt process (Project 2)
IVRS design standards (Project 2
Forecasting guidelines and inventory models to ooptimize inventory levels (Project 2
Standardization (Project 2)
More structure in planning and management activities (Project 2
Efficiency and quality of service provided (Project 2)
N
C
N
N
C
PVP /
GPT /
ITM
Standardization (All) Front-loading of tasks
(Project 3 + Project 1) Early decision making
(Project 3 + Project 1) Compliance / lead-
times (All) Visibility of demand
(Project 4) Feed-back loop /
continues learning (Project 4)
Project 4 Concept Project 1 concept IVRS concept Mngt reporting
(Project 3 + Project 4 BW)
Demand setting (Project 4)
Project and portfolio review process (Project 4)
Availability of CDP in timely manner for supplies planning & Project 1 frontloading (Project 2 + Project 1)
Project 1 usage decision (Project 1)
Resource allocation (Types and timing for Project 1 trials (Project 1)
Changed process for CDP design research (Project 3)
N C Time reporting Resource analysis /
continues learning (Project 4)
N Availability of protocol in timely manner for supplies planning (Project 2)
IVRS decision tree / mngt process (Project 2)
Changed process for protocol design research (Project 3)
Early update of plans with key dates for Project 1 (Project 1)
C
N
N
C
Changed process for IB design research (Project 3)
C Optimal subject recruitment levels (Project 2)
Enhanced possibilities in monitoring enrolment display of patient levels at different sites (Project 2, Project 1, CSW)
C
Changed process for inventory management and drug accountability on IVRS trials (Project 2)
C
Standardization (Project 1)
Front loading of tasks (Project 1)
Investigator / Site interaction (Project 1)
Ongoing tasks (Project 1)
Split of remote vs. onsite tasks (Project 1)
Potential change of the monitor role (Project 1)
Project 1 concept and tool (Project 1)
Increased IVRS use (Project 2)
Forecasting & inventory mngmt concept (Project 2)
IVRS Tool (Project 2)
C
C
C
Site Project 1 feasibility check (Project 1)
Set-up and training of site users (Project 1)
N
N
Enhanced possibilities in monitoring enrolment status (Project 2, Project 1, CSW)
C
C Remote data monitoring / review (Project 1)
Change in archiving process (Project 1)
Changed process for CRF tracking (Project 1)
N
C
C
• Use of Project 1 tool and frontloading of tasks; early data and ongoing review/cleaning (Project 1)
• Stop of paper CRF collection, resupplies, scanning to eSubmission (Project 1)
• Reduce day-to-day site inventory mgmt (Project 2)
C
From paper to more electronic tools (IVRS, Project 1)
IVRS concept and tool (Project 2)
Project 1 Concept and tool (Project 1)
Site Project 1 feasibility check (Project 1)
Set-up and training of site users (Project 1)
Formalised use of IVRS to manage subject recruitment levels (Project 2)
Use of Project 1 tool for data capture & query resolution (Project 1)
Dispensing calls to manage site inventory (IVRS) Safety data collection possible through Project 1
rather than faxing (Project 1)
N
N
N
N
N
C
S
Earlier timing of trial set-up components, and decision making; eg. quality excp, how to handle and act on deviations etc.(Project 1)
N
C
Standardization (Project 1)
Front loading of tasks (Project 1)
Ongoing tasks (Project 1)
Project and portfolio review process - managers (Project 4)
C
Project 1 concept and tool (Project 1)
Project 3 concept and tool (Project 3)
Project and portfolio review process - managers (Project 4)
C
Project and portfolio review process - managers (Project 4)
C
Earlier and ongoing data cleaning and validation (Project 1)
Changed process for CRF tracking (Project 1) Changed process for medical coding (Project
1) Changed process for SAE Reconciliation
(Project 3)
Changed process and deliverables for DBR incl. shortened time span from LPLV to DBR (Project 3+Project 1)
DW Adm. Standardization Bridging DM and Stat
New role
N
C
C
C
Earlier timing of trial / DB set-up components, and decision making (Project 1) N C
Enter design trial data before FPFV (Project 3)
Administration of Project 3 and availability of data (simulated data, blinded data, un-blinded data, frozen data snap-shots)
N N
Standardization (Project 1+Project 3)
More analysis / interpretation (Project 3)
Front loading of tasks (Project 1+Project 3)
Project 1 concept and tool (Project 1)
Project 3 concept and tool (Project 3)
Early creation of SAP (Project 1 + Project 3) Earlier and ongoing data review and analysis. Earlier
confirmation of data quality (Project 1 + Project 3)
N N
Earlier and ongoing data review. Earlier confirmation of data quality (Project 1+Project 3)
N
Less programming, table look-up and validations (Project 3)
Fewer request for programming (Project 3) Use of new standard tables and standard
reports (Project 3) More time for analysis and interpretations
(Project 3)
C
C
N
N
Trial management, review groups, Project 1 set-up resp. unit, CSO/CSCo: Alignment of CDP, Protocol to ensure Supply planning (Project 2) and Project 1 frontloading (Project 1)
Project and portfolio review process - managers (Project 4)
C
Project and portfolio review process - managers (Project 4)
C
Trail mngmt, DM, Stat: Interaction and work pattern in trial and DB set-up (Project 1)
LTM/Monitor, Investigator: Site interaction and work-pattern (Project 1, Project 2)
Monitor, DM, DW adm, Stat, MW: Interaction and work pattern in data cleaning, review, confirmation of quality, access and analysis (Project 3+Project 1)
N
Time reporting N
Time reporting N
Time reporting N
Time reporting N
Time reporting N
Time reporting N
Mindset & Skills
C
Electronic archiving (Project 1)
N
Earlier completion of final ITCR (Project 1 + Project 3)
C Standardization
(Project 1) Front loading of tasks
(Project 1) Ongoing tasks (Project
1)
Project 3 concept and tool (Project 3)
= New task
= Changed task C
N
Earlier process for site selection (Project 1)
Early update of plans with key dates for Project 1 (Project 1)
Set-up mapping to Project 3 before FPFV (Project 3)
IVRS data standards
N
N
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 13
NNIT – EA and Pharma
Pharmaceutical Companies are also starting to embrace Enterprise Architecture However, traditionally a strong segmentation of the organisations have meant that smaller and often isolated architectures have been developed An internal push for Pharma Companies to start initiatives covering the entire business vertical as well as horizontal is observed A desire to spend an ever-decreasing IT budget on value-adding initiatives instead of maintenance supports the push
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 14
Gartner – Enterprise Architecture Focus
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 15
Setting the direction
Photo: Glassmerchant, UK, blog.TravelPod.com
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 16
NNIT Process Vision
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 17
The three levels that should be perfected
Ease Cost
Business benefits
Technology
Processes
Definitions
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 18
Definitions
The basic things, that must be in order
Culture (Governance , Project, Compliance, etc)
Standards
Meta and master data
Data models
Data exchange formats
Naming conventions
Ownership
Authoring – what application owns what data
Processes
Strategies (IT, business)
Technology
Processes
Definitions
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 19
Processes
Departmental collaboration and sharing of data
Access to data (global), enabling fastest possible actions
Local and global operating procedures – fit to each other
Governance model
Process descriptions and reporting
Streamlining, optimisation, procedural flexibility
Technology
Processes
Definitions
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 20
Technology (vision)
Plug and play applications
SOA environment
Clinical Portals for internal and external people
Real-time reporting of trial status and progress
Efficient and feedback based simulations of trial situations
Technology
Processes
Definitions
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 21
In
ho
use
Ou
tso
urced
Present clinical application architecture
CTMS• Generate and maintain non-subject trial
data e.g. trials, countries, sites,
investigators,
• Generate subject visit schedules
• Generate enrolment forecasts, milestones
and monitoring & treatment progress
reports
• Verify source data (pCRF)
• Track CRF pages (pCRF)
• Report screen failure/reason
• Track and report site activation
• Generate enrolment report
• Report withdrawal/reason
• Green light, Supplies strategy
• Site Activation
EDC• Design electronic CRFs
• Design database for clinical data
• Manage eCRF data entry and review
• Manage and track data discrepancies
• Verify source data
• Record investigator approval of eCRF data
• Capture screen failure & withdrawals
• Collect key efficacy data for interim
analysis
• Capture SAEs
• Track eCRF pages
Clinical Supply
Chain• Manage product data and bills of
materials
• Manage inventory and raw materials
• Generate randomisation schedule codes
• Manage clinical packaging orders
IVRS• Unblinding – (IPS via IVRS)
• Randomize subjects
• Calculate dose for dispensing
• Maintain drug inventory
• Maintain drug status
• Capture screen failure & withdrawals
• Productive – site visit dates
(investigator)
CDMS• Design database for clinical data
• Manage pCRF data entry and review
• Track missing pCRF pages (pCRF)
• Edit check data and resolve queries
• Load and range check external data
• Code AEs, SAEs, concomitant
medications & medical history
• Investigate Information-amended CRF
pages
• Check range and consistency in patient
identifiers/visit dates
External Data• Laboratory data
• ECG data
• Electronic patient diary data
• CRO Patient Load
Safety• Capture SAEs (eCRF)
• Enter SAE data from CIOMS (pCRF)
• Code SAEs
• Record and track safety cases
• Query and analyse safety data
• Report pharmacovigilence information to
regulatory authorities
CIOMS Data• SAE information from
pCRF studies
External
Packaging
Facility/local
depots
• Fax
Resource Portfolio
Management
Project tool• Maintain project plans
• Define time budgeting structure
ERP system• Highlight supply/demand
resource gaps to support review
process
• Record actual time & resource utilisation.
• Allocate costs
• Project &
building blocks
• Resources
EDMS• Store, retrieve and track regulatory
documents
• Manage document versioning and
change control
• Support publishing and electronic submissions to authorities
• Provide document search capabilities
• Initial shipment request (manual)
• Re-supply requests (manual)
• Shipment details
Clinical Data
Warehouse
Data Warehouse• Handle Clinical and Operational data
• Handle study metadata
• Reconcile SAEs
SCE• Handle and analyse statistical data
• Calculate statistically derived
parameters
• Define study populations
• Conduct statistical analysis and
reporting
• Maintain std. program library
• Patient Demographic data (eCRF)
• Clinical Data (eCRF)
• Site Number (eCRF)
• Box/lot dispensed*
• End of trial enrolment
notification (pCRF + eCRF)
• Screen failures (pCRF + eCRF)
* Subject to drug + batch accountability
discussion
• Trial identification data
• Site monitor and investigator details
• Site activation notification
• Shipping Address
• Green Light Date
• Supplies Strategy per clinic
• End of trial enrolment notification
(screening)
• End of trial randomization notification
(LPFV)
• Screen failures, codes + dates (pCRF)
• Withdrawals, codes + dates (pCRF)
• Patient Identifiers, visit dates, DoB, Gender
(+ other data recorded today)
• Trial identification data
• Site address details
• Initial shipment request (manual)
• Re-supply requests (manual)
• Randomization
schedule & codes
• Shipment
details
• Trial identification data
• Site & investigator details
• KPI data
• Protocol deviations (NTF &
analyses)
• Study data tabulation model
(manual)
• SAEs for reconciliation
• Database annotation Doc
• Data handling plan
• DM SAEs for reconciliation
• Patient Demographic Data
• Cleaned Clinical Data
• Captured SAEs
(eCRF, from EDC)
•Trial data
• Trial identification data
• Site & investigator details
• Subject Information
• Box #, Lot #, RAN #
• Treatment group
• DoB
• Straticification
• Withdrawals (pCRF + eCRF)
• New subject enrolment (eCRF)
• Subject Completion
• Trial identification data
• KPI Data
Clinical Trial
Disclosure
Clinical Portal
• Trial identification data
Protocol
Design•Clinical and Study metadata
•Study design standards
•Study
design
standards
•Study
design
•Study
design
•Study
design
standards
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 22
Future application architecture
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 23
Case Story – Introducing New Standards & Governance
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 24
The Approach
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 25
(Preliminary Phase) Identified and prioritised
pains and opportunities Issues and root causes Critical success factors and
enablers Benefits Specific business case areas
to develop in the planning phase
Architecture vision
Specific Roadmap and priorities
Architectures – 1st round Business case for each
opportunity for Exec Phase Relative business value,
Priorities, Dependencies Implementation plan,
Technology enablement, Risk Assessment Program management plan Standards and templates
Planning
Architectures – 2nd round Programme office Specification Vendor selection Implementation Roll-out Benefit realization OCM (change
management)
Execution
Project delivery approach (example)
The NNIT approach follows a gate-model, to ensure objectives and sponsorship for each phase are met, before starting the next
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 26
Case Story
A medium-sized pharmaceutical company initiated a pre-project together with NNIT with the scope of defining a change program for the optimisation of their clinical development by introducing a Clinical Data Warehouse (CDW) and a Statistical Computing Environment (SCE):
A preliminary phase was conducted
Overall vision for the program was formulated
High-level architectures were constructed
Business cases were developed
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 27
Data Collection Process Today
Analysis & Long List
Business Cases
Business Cases Data Collection
80 Questionnaires
45 Interviewees
383 Statements: •Duplicate •OCM •Other
Prioritisation
Mapped against: Focus Area Process Project Candidate
224 Findings
607 Statements
10 Impr. Areas
Priority Meeting
Workshop
50 Statements: •OCM
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 28
Programme Vision
Current State
HIP Vision
Short Term
Year 0-2
Long Term
Year 6… Medium Term
Year 3-5
Based on our analysis, it was at this point clear that a CDW and a SCE could only be introduced after a foundation project with the scope of introducing CDISC standards for CRF and clinical databases had been performed.
Vision
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 29
Foundation
Programme
Simplified working processes
Optimised use of clinical data
Easy sharing of data and
best practices
Clinical Data Warehouse
Standardisation
Coding Data Acquisition and Management
Statistical Computing
Environment & Data Visualisation
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 30
Standardisation Project
The project had two main tracks:
1) the actual, hands-on mapping of existing standards to the new standards (SDTM, ADaM) including the development of methods and procedures
2) the handling of the related procedural and organisational changes, ensuring the transition, and the development and introduction of standards governance, maintaining the standards.
The presentation will focus on the latter part, namely the OCM exercise, with emphasis on the implementation of a standards governance organisation.
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 31
Solution overview - Standardisation start point
Protocol CRF
Design Data
Capture
Clinical Data Base
Securing SDTM format
Implementing SDTM format
Start and end point is SDTM format
definition
Clinical Data
Warehouse
Analysis &
Reporting
Clinical Data Base
Clinical Data Base
Clinical Data Base
Clinical Data Base
Clinical Data Base
ADAM for the trials
Author: xxxx • Approved by: xxxx • Version xx INTERNAL USE ONLY Slide 33
Organisational Change Management Goals
During the project, it must be ensured that all employees and
stakeholders that either have influence on, or are impacted by,
the project, will:
Understand the impact of the project
Understand their role in the implementation of the changes to processes and structures
Support the project goals
Have commitment to help with the success of the project
Have the ability to follow the new and changed processes and procedures
Accept the changes and understand related benefits
If this is successful, there is a high chance that the desired
change in behaviour is realised after the project
Author: xxxx • Approved by: xxxx • Version xx INTERNAL USE ONLY Slide 34
Main perceived barriers - expected from stakeholders
Reduction of creativity – it‟s like working in a factory, you
take away my innovation power
Loss of power
It‟s not my problem!
Habits and „we do not have time‟
Author: xxxx • Approved by: xxxx • Version xx INTERNAL USE ONLY Slide 35
OCM Approach
Content included the following:
Scoping & Planning
Mandate from Management
Stakeholder management
Communication Principles
Procedural change mapping
Line of Business buy-in
Standards Governance
Organisational Change Mapping – Obstacles
Training setup
Learning points & Conclusion
Planning for the unexpected
Author: xxxx • Approved by: xxxx • Version xx INTERNAL USE ONLY Slide 36
Standardisation Project
Operational Performance
QA
OR
HR
Data Mgt. & Coding
Clinical DB
Medical Writing
Med Directors
Project CTMs and Directors
Med resp
Strategic Planning
Clinical Data
Division
Medical Department
XXX
Other Areas
IS/IT
Areas with impact
Pharmaco-vigilance
Clinical Operations
XXX
CRO Negotiation
Finance
Methodologies
and Clinical Data
Analysis Division
Clinical BI
Safety
Statistics
Impact Map
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 37
Governance = Clear Responsibility/Authority
Patient Data
Supply
Safety
Statistical Analysis
Trial Meta Data
Registration
Submission Data
Resource Management
Management Reporting
Non-clinical Trial Data
Clinical Trial
Manager
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 38
Governance and Standards
Governance
Continuous Improvement
Implement
Standards
Involvement in definition of standards
Strong ownership and governance of standards
Processes for maintaining and improving the standards
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 39
Principles for Standards Governance Governance Organisation must be involved right from the first draft of protocol
for all studies
Using the current version of the Standards is obligatory
Approved exceptions are allowed
Exceptions will be facilitated by the governance and appropriate tools
CDISC nomenclature and terminology (data structure and code lists) cannot be changed
All exceptions and changes have an impact and must be motivated by the requester
Processes for Exception and Change Requests must be followed, leading to „Accepted‟ or
„Rejected‟ status, ensuring minimal delay to the progress of the study
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 40
Standards Governance Organisation
SGM: Standards Governance Manager SDM: Standards Domain Manager
SDM
CRF & DB Standards
Group
SDM
Statistical Standards
Group
SDM
Protocol Standards
Group
Protocol Standards
Group
SGM
Standards Governance
Manager
SDM
Coding & PV Standards
Group
Standards Governance Committee
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 41
Resource Impact analysis
5 SGM + SDMs +
SDG
SGM Ensure
Implementation
15
Relevance / Completeness
3
SGM
Exception Request Process
Ensure exception list and
documentation is updated
17
Exception request (ER) completion
2
No
Ensure Exception list and
documentation is updated
19
Exception Needed
1
Requester
Categorization
6
Complete and document ER for further analysis
4
Yes SGM
+ SDMs
Perform Implementation
16
LoB
Approval SGM
8
No Escalation by Requester
9
SGM
Minor/ Medium
Impact analysis
7
SGC
ER handling by SGC
11 Yes
Yes ER Approval Transmission
13
Yes
No
No ER Reject transmission
14
Approval
12
To Change Request
18
Major Impact analysis
10
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 42
Conclusion
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 43
Results
Governance Processes
Protocol CRF Database Analysis Report
Standards Library
Project/Trial
Phase
Therapeutic Area
Global
Governance Reporting
Governance Organisation
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 44
Industry maturity assessment
Basic Advanced Industry Average
AS-IS TO-BE
Vision & Strategy
Governance
Compliance
Standards
System landscape
IT Strategy
Governance Model
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 45
Observed project challenges
Implementation of a new architecture is a major task, which requires:
Strong management buy-in from the very top of the company
Shared vision and goal
Decision power
Long term plan and funding
Organisational visibility and linkage
Strong planning and governance capabilities
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 46
Its about being in control!
Definitions
Have high attention on Company Vision, Culture, Standards, Ownership of responsibilities – Clear Strategies for Change
Processes
Well defined & efficient, that produce reliable results without requiring superhuman effort!
Technology
Tools to facilitate, automate, integrate the processes, leverage the standards and allow us to use our ”human” resources to best advantage
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 47
Questions
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 48
Bjørn Hjorth-Sørensen D.Phil, MSc Principal Consultant
NNIT A/S Buddingevej 197 DK-2860 Soeborg Denmark
+45 3075 9668
[email protected] www.nnit.com
Special thanks to Henrik Nørgaard Rasmussen & Birgitte Agergaard
Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 49
Always be open and honest