Enabling IDMP
with best in
class
technology
solutions
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
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
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.
Learn more:
Accenture.com/regulatory

IDMP

  • 1.
    Enabling IDMP with bestin class technology solutions
  • 2.
    STRATEGIC RELEVANCE OFIDMP 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 DATASUPPLY 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 Datamapping 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.