Clinical Data Management ProcessBy Nageswararao . Y

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Clinical Data Management – Process Flow

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Clinical Data Management – Process Flow

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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

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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

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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

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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

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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

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Clinical Data Management – Process Flow

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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

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