Clincial Data Management

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Clincial Data Management

  1. 1. Clinical Data ManagementProcessByNageswararao . Y 1
  2. 2. Clinical Data Management – Process Flow 2
  3. 3. Clinical Data Management – Process Flow 3
  4. 4. Clinical Data Management – Technology Landscape Data Standards SDTM Digitization Data Analytics ODM/LAB Operational Data Analytical Data DB Lock ODM EDC Operational Data Submissions Data Document Mgmt. Clinical Documents IROP® Platform ` BCP/DR Secure C onnectivity i Skilled Staff Office Space Servers Quality Control 4
  5. 5. Digitization  Double data entry  Verification and Validation Scanning the source documents and tagging the source data with electronic format activities 21 CFR 11 requirements analysis  Data Clarification and Query Preparation of Data Management Plan Resolution Digitization tool selection Creation of Data Entry screens  Quality control Creation of Edit Checks and Data Quality  Database locking and checks Data Security implementation preparation for submission Tagging the data elements into CDISC compliant ODM data Database Design Solutions  Oracle Clinical, Phase Forward and Data Labs solution  Custom built Digitization solution 5
  6. 6.  Data Analytics  Preparation of Statistical Analysis Plan  Creation of data marts  Creation of tables and listings  Performing Statistical Analysis using SAS  Analysis of Pharmacokinetic, Epidemiological and Clinical Trial Data  Clinical Report generation  Creation of Domain sets as per CDISC SDTM (Study Data Tabulation Model)  Regulatory submissions using SAS Solutions  SAS 9 platform 6
  7. 7. Electronic Data Capture  DCF and Query closure  Patient Diary integration Feasibility Analysis of implementing EDC Study/ Site data collection methodology  Adverse Event data integration 21 CFR 11 requirements analysis  Build EDC Database Preparation of Data Management Plan  Simulate actual EDC data entry using EDC Tool selection Simulation mode Interface design for integration with external data sources (including Hybrid approaches) Solutions EDC Screen Design Edit Check identification Data Security implementation  Oracle Clinical, Phase Forward and MediData Data Interoperability using Operational solutions Data Model (CDISC-ODM)  Custom built EDC solution 7
  8. 8. Document Management Services  Lifecycle management  Define. PDF creation from Clinical data Analysis of Enterprise Document Management needs  Document Workflow management services Design/ Implementation of Enterprise  Docket preparation (local and global) Document Management solutions Integration of different Document  IND and NDA preparation Management solutions for CDMS Integration of Contract and Financial data Solutions from different sites Integration of Clinical data from different sites  Documentum, Open Text and Adobe solutions Integration of LAB and ECG data from  Integration of existing CDMS systems to multiple sites Enterprise Document Management Systems CRF data conversion to documents Protocol Authoring Services Configuration/ Administration 8
  9. 9. Data Standardization Feasibility study for data standardization Business Case preparation for implementing CDISC standards Translation of protocol into ODM, SDTM ready data elements Technology Implementation CDISC conformance audit on your existing systems / tools/ standards CDISC compliant tool selection Interoperability analysis using ODM and LAB standards Conversion of existing CDMS, CTMS systems to be CDISC compliant Preparation of SDTM compliant data sets Preparation of CRT data sets Preparation of Define.pdf and Define.xml for submission Project ManagementStandards Operational Data Model LAB Data Model Study Data Tabulation Model 9
  10. 10.  Rack servers with tape backup Business continuity plan/ Disaster Recovery procedures Redundant backup Information Security Policies Latest hardware/software Multiple vendors managed networks to ensure 24/7 access to data across the globe Physical/ Logical access controls established Power backup/ Generator facility 24/7 managed infrastructure by a team of skilled Administrators, DBAs Rigorous SOPs 10
  11. 11. Clinical Data Management – Process Flow 11
  12. 12. Clinical Data Management – Process Flow 12
  13. 13. Clinical Data Management – Technology Landscape Data Standards SDTM Digitization Data Analytics ODM/LAB Operational Data Analytical Data DB Lock ODM EDC Operational Data Submissions Data Document Mgmt. Clinical Documents IROP® Platform ` BCP/DR Secure C onnectivity i Skilled Staff Office Space Servers Quality Control 13
  14. 14. Digitization  Double data entry  Verification and Validation Scanning the source documents and tagging the source data with electronic format activities 21 CFR 11 requirements analysis  Data Clarification and Query Preparation of Data Management Plan Resolution Digitization tool selection Creation of Data Entry screens  Quality control Creation of Edit Checks and Data Quality  Database locking and checks Data Security implementation preparation for submission Tagging the data elements into CDISC compliant ODM data Database Design Solutions  Oracle Clinical, Phase Forward and Data Labs solution  Custom built Digitization solution 14
  15. 15.  Data Analytics  Preparation of Statistical Analysis Plan  Creation of data marts  Creation of tables and listings  Performing Statistical Analysis using SAS  Analysis of Pharmacokinetic, Epidemiological and Clinical Trial Data  Clinical Report generation  Creation of Domain sets as per CDISC SDTM (Study Data Tabulation Model)  Regulatory submissions using SAS Solutions  SAS 9 platform 15
  16. 16. Electronic Data Capture  DCF and Query closure  Patient Diary integration Feasibility Analysis of implementing EDC Study/ Site data collection methodology  Adverse Event data integration 21 CFR 11 requirements analysis  Build EDC Database Preparation of Data Management Plan  Simulate actual EDC data entry using EDC Tool selection Simulation mode Interface design for integration with external data sources (including Hybrid approaches) Solutions EDC Screen Design Edit Check identification Data Security implementation  Oracle Clinical, Phase Forward and MediData Data Interoperability using Operational solutions Data Model (CDISC-ODM)  Custom built EDC solution 16
  17. 17. Document Management Services  Lifecycle management  Define. PDF creation from Clinical data Analysis of Enterprise Document Management needs  Document Workflow management services Design/ Implementation of Enterprise  Docket preparation (local and global) Document Management solutions Integration of different Document  IND and NDA preparation Management solutions for CDMS Integration of Contract and Financial data Solutions from different sites Integration of Clinical data from different sites  Documentum, Open Text and Adobe solutions Integration of LAB and ECG data from  Integration of existing CDMS systems to multiple sites Enterprise Document Management Systems CRF data conversion to documents Protocol Authoring Services Configuration/ Administration 17
  18. 18. Data Standardization Feasibility study for data standardization Business Case preparation for implementing CDISC standards Translation of protocol into ODM, SDTM ready data elements Technology Implementation CDISC conformance audit on your existing systems / tools/ standards CDISC compliant tool selection Interoperability analysis using ODM and LAB standards Conversion of existing CDMS, CTMS systems to be CDISC compliant Preparation of SDTM compliant data sets Preparation of CRT data sets Preparation of Define.pdf and Define.xml for submission Project ManagementStandards Operational Data Model LAB Data Model Study Data Tabulation Model 18
  19. 19.  Rack servers with tape backup Business continuity plan/ Disaster Recovery procedures Redundant backup Information Security Policies Latest hardware/software Multiple vendors managed networks to ensure 24/7 access to data across the globe Physical/ Logical access controls established Power backup/ Generator facility 24/7 managed infrastructure by a team of skilled Administrators, DBAs Rigorous SOPs 19
  20. 20. Thank you

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