Enabling IDMP with best in class technology solutions

1. Enabling IDMP
with best in
class
technology
solutions

2. STRATEGIC RELEVANCE OF IDMP
Become
compliance ready
Increase
compliance
efficiency
Digitize R&D
across functions
Build advanced
analytics
• Implement basic
prerequisites to be
IDMP submission ready
• Increase master data
quality and
consistency
• Increase processual
compliance in
organization
• Raise automation as
much as possible
• Digitize processes and
systems across R&D
functions
• Integrate data
governance and data
management
• Develop and network
reporting structures
across the
organization
• Build predictive
analytics capabilities
within the company
IDMP initiatives can be used as a starting point to drive major strategic initiatives across
R&D functions, increase compliance, expedite digitalization, and build predictive
analytic capabilities within R&D
Preparing for IDMP can be a driver for major strategic
initiatives

3. DEFINE DESCRIBE EXECUTE
DISCOVER
DATA SUPPLY
TECHNOLOGY
PROCESS
CHANGE
MANAGEMENT
DATA ASSESSMENT
• Source Identification
• Source Mapping & Profiling
• Pilot product(s) quality analysis
DATA REMEDIATION
• Improve data quality
• Close source gaps
• Define data catalogues
DATA COLLECTION
• Agree product sequencing
• Standardize quality checks
ROADMAP and ROM ESTIMATION
• Define detailed project charters for
key enabling projects.
• Work with organization to identify
process owners and change agents.
• Identify opportunities to adopt
automated approaches during
execution phase.
• Identify dependencies and risks to
delivery or timelines.
• Formulate ROM investment and
value case.
• Draft implementation roadmap with
consideration to dependencies and
risks.
TECHNOLOGY SELECTION
• Define requirements, solution
architecture, future state
tools/technologies
TECHNOLOGY IMPLEMENTATION
• Implement solution for extracting,
maintaining and submitting IDMP
compliant data
TECHNOLOGY ASSESSMENT
• As-is & to-be landscape
• Assess interoperability
PROCESS ASSESSMENT
• Define impacted processes and
function interconnectivity
PROCESS CREATION
• Define future state processes
PROCESS IMPLEMENTATION
• Implement process transformation
• Create and Submit IDMP messages
• Maintain IDMP data compliantly
CHANGE ASSESSMENT
• Stakeholder Analysis
• Organizational Impacts
DATA LANDSCAPE ASSESSMENT
• Define the maturity of the current
data landscape – data governance,
master data management, data
quality framework
CHANGE IMPLEMENTATION
• System Superusers
• Change Agents supporting adoption
DATA GOVERNANCE DEFINITION
• Define requirements for:
• Controlled Vocabularies
• Data Standardization
• Data Ownership
• Data Stewardship
CHANGE PLANNING
• Training
• Communication Management
DATA
GOVERNANCE
DATA MANAGEMENT
• Implement processes and governance
for:
• Reference Data Management
• Master Data Management
• Data Quality
• Maintenance of Data Catalogues
Accenture’s four-phased approach to assess IDMP
readiness across these tiers.
Data analysis and mining Data mapping and extraction Data cleansing and enrichment Collect and maintain
IDMP compliant data
IDMP
submission
1 3
2 4 5

4. 4
Data analysis and
mining
Data mapping and
extraction
Data cleansing and
enrichment
Collect and maintain
IDMP compliant data
IDMP submission
1 3
2 4 5
IDMP SPOR check and enrichment
of database if necessary
Automation
AI tool
AI tool
Automation
Auto mapping
with e.g. MedDRA
Automation
Enabling IDMP with best in class technology solutions.

5. Learn more:
Accenture.com/regulatory