1. Clinical Data Management
Process
By
Nageswararao . Y
1

2. Clinical Data Management – Process Flow
2

3. Clinical Data Management – Process Flow
3

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. 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.  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. 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. 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. 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 Management
Standards
 Operational Data Model
 LAB Data Model
 Study Data Tabulation Model
9

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. Clinical Data Management – Process Flow
11

12. Clinical Data Management – Process Flow
12

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. 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.  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. 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. 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. 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 Management
Standards
 Operational Data Model
 LAB Data Model
 Study Data Tabulation Model
18

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. Thank you