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Clinical Data Management ProcessBy Nageswararao . Y
1
Clinical Data Management – Process Flow
2
Clinical Data Management – Process Flow
3
Clinical Data Management – Technology Landscape
Data Analytics
Clinical Documents
Operational Data
Analytical Data
Submissions Data
ODM/LAB
DB Lock
SDTM
Operational Data
ODM
Data Standards
Digitization
EDC
Document Mgmt.
IROP® Platform
BCP/DR
Servers
Skilled Staff Office Space
Secure Connectivity
`
Quality Control
i
4
Clinical Data Management – Typical Activities
Digitization
Scanning the source documents and tagging the source data with electronic format
21 CFR 11 requirements analysis Preparation of Data Management Plan Digitization tool selection Creation of Data Entry screens Creation of Edit Checks and Data
Quality checks Data Security implementation Tagging the data elements into CDISC
compliant ODM data Database Design
Double data entry Verification and Validation
activities Data Clarification and Query
Resolution Quality control Database locking and
preparation for submission
Solutions
Oracle Clinical, Phase Forward and Data Labs solution
Custom built Digitization solution
5
Clinical Data Management – Typical Activities 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
Clinical Data Management – Typical Activities
Electronic Data Capture
Feasibility Analysis of implementing EDC
Study/ Site data collection methodology
21 CFR 11 requirements analysis Preparation of Data Management
Plan EDC Tool selection Interface design for integration
with external data sources (including Hybrid approaches)
EDC Screen Design Edit Check identification Data Security implementation Data Interoperability using
Operational Data Model (CDISC-ODM)
DCF and Query closure Patient Diary integration Adverse Event data integration Build EDC Database Simulate actual EDC data entry using
Simulation mode
Solutions
Oracle Clinical, Phase Forward and MediData solutions
Custom built EDC solution
7
Clinical Data Management – Typical Activities
Document Management Services
Analysis of Enterprise Document Management needs
Design/ Implementation of Enterprise Document Management solutions
Integration of different Document Management solutions for CDMS
Integration of Contract and Financial data from different sites
Integration of Clinical data from different sites
Integration of LAB and ECG data from multiple sites
CRF data conversion to documents Protocol Authoring Services Configuration/ Administration
Lifecycle management Define. PDF creation from Clinical data Document Workflow management
services Docket preparation (local and global) IND and NDA preparation
Solutions
Documentum, Open Text and Adobe solutions
Integration of existing CDMS systems to Enterprise Document Management Systems
8
Clinical Data Management – Typical ActivitiesData 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 Management
Standards Operational Data Model LAB Data Model Study Data Tabulation Model
9
Clinical Data Management – Infrastructure / Platform requirements
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
Clinical Data Management – Process Flow
11
Clinical Data Management – Process Flow
12
Clinical Data Management – Technology Landscape
Data Analytics
Clinical Documents
Operational Data
Analytical Data
Submissions Data
ODM/LAB
DB Lock
SDTM
Operational Data
ODM
Data Standards
Digitization
EDC
Document Mgmt.
IROP® Platform
BCP/DR
Servers
Skilled Staff Office Space
Secure Connectivity
`
Quality Control
i
13
Clinical Data Management – Typical Activities
Digitization
Scanning the source documents and tagging the source data with electronic format
21 CFR 11 requirements analysis Preparation of Data Management Plan Digitization tool selection Creation of Data Entry screens Creation of Edit Checks and Data
Quality checks Data Security implementation Tagging the data elements into CDISC
compliant ODM data Database Design
Double data entry Verification and Validation
activities Data Clarification and Query
Resolution Quality control Database locking and
preparation for submission
Solutions
Oracle Clinical, Phase Forward and Data Labs solution
Custom built Digitization solution
14
Clinical Data Management – Typical Activities 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
Clinical Data Management – Typical Activities
Electronic Data Capture
Feasibility Analysis of implementing EDC
Study/ Site data collection methodology
21 CFR 11 requirements analysis Preparation of Data Management
Plan EDC Tool selection Interface design for integration
with external data sources (including Hybrid approaches)
EDC Screen Design Edit Check identification Data Security implementation Data Interoperability using
Operational Data Model (CDISC-ODM)
DCF and Query closure Patient Diary integration Adverse Event data integration Build EDC Database Simulate actual EDC data entry using
Simulation mode
Solutions
Oracle Clinical, Phase Forward and MediData solutions
Custom built EDC solution
16
Clinical Data Management – Typical Activities
Document Management Services
Analysis of Enterprise Document Management needs
Design/ Implementation of Enterprise Document Management solutions
Integration of different Document Management solutions for CDMS
Integration of Contract and Financial data from different sites
Integration of Clinical data from different sites
Integration of LAB and ECG data from multiple sites
CRF data conversion to documents Protocol Authoring Services Configuration/ Administration
Lifecycle management Define. PDF creation from Clinical data Document Workflow management
services Docket preparation (local and global) IND and NDA preparation
Solutions
Documentum, Open Text and Adobe solutions
Integration of existing CDMS systems to Enterprise Document Management Systems
17
Clinical Data Management – Typical ActivitiesData 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 Management
Standards Operational Data Model LAB Data Model Study Data Tabulation Model
18
Clinical Data Management – Infrastructure / Platform requirements
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
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