CDM Integrity Systems — Clinical Data Management

CDM ECOSYSTEM · MASTER TEXT

The heart and DNA of clinical research.

The complete CDM model library: origin, principles, connected processes, integrity, security, quality, evidence and vision.

40 CHAPTERSCOMPLETE CORPORATE SOURCE
Why CDM was created
Why CDM was created
How CDM orchestrates the clinical research ecosystem
How CDM orchestrates the clinical research ecosystem

40 CHAPTERS

01

Why was CDM created?

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02

CDM is not a collection of tools

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03

CDM is an ecosystem

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04

One data point, one source

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05

One action feeds the next

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06

CDM turns data into information flow

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07

From human filtering to human oversight

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08

CDM and Regulatory Affairs — From document filing to active regulatory management

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09

CDM and electronic signatures

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10

CDM and SOPs — From written procedure to demonstrable implementation

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11

CDM and staff and equipment management

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12

CDM and Start-up

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13

CDM and deviation management

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14

CDM and SAE management

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15

CDM and Quality — From findings to institutional learning

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16

CDM TeleCare — Clinical continuity beyond the site

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17

CDM and Finance — From reconstructing activity to receiving execution data

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18

CDM and Clinical Monitoring — Monitoring reliable information

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19

CDM and the Audit Trail

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20

CDM and role-based access

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21

CDM and remote monitoring

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22

CDM and temporal consistency

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23

CDM and signature/validation

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24

CDM and document structure

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25

CDM and the monitoring experience

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26

CDM Integrity Systems — Security by architecture

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27

CDM protects data throughout its lifecycle

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28

CDM protects the infrastructure

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29

CDM Sentinel — The compliance, control and trust layer

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30

CDM turns standards into controls

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31

CDM automates part of compliance

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32

CDM and privacy in Sentinel

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33

CDM turns security into demonstrable security

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34

CDM builds three levels of trust

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35

CDM reduces the cost of fragmentation

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36

CDM and Quality by Design — Quality is part of the architecture

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37

The DNA of Clinical Data Management Integrity Systems

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38

CDM: from digitization to orchestration

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39

The pillars of CDM

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40

Our vision

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