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IDMP

Enabling IDMP with best in class technology solutions

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IDMP

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

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