Rise of Genomics in Clinical Trials - 7

Rise of Genomics in Clinical Trials * Leveraging Genomics to De-Risk Clinical Trials and to Enhance Outcomes

* Bioinformaticians deploy, test, and validate
their pipelines and reports in CTS

* Participants' DNA samples are processed by

Customer Journey: From Users to Enterprises

Clinical Trials Solution

sequencing partners, and results are uploaded
to the CTS for validated analysis and reporting

adaptive trial design for umbrella
& basket trials
§ Patient stratification: Molecular &

clinical inclusion criteria to match
patients to optimal treatment arm

* Sequencing partners track the status of
their data and analyses using the CTS service
provider interface

§ Real-time Analysis: Enables

§ Identify markers of efficacy:

Patients

Study
Physicians

Central Labs

genomic data combined with
response data

Sequencing
Labs

§ Adverse event monitoring:

Integrated analysis to identify
genomic markers of adverse
response

* Trial clinicians monitor validated analysis
pipelines using the CTS clinician interface
In
si
gh
ts

* Genomic analysis results and reports are
sent to study physicians and directors, and
deposited into the electronic data capture
system of record

*
Bioinformatician -
Pipeline designer

Security, privacy, quality, and compliance are
core attributes of the CTS, providing the
versioning, tracking, logging, auditability, and
reproducibility enabling research discoveries
to be readily translated into clinical development
and clinical diagnostics.

7

| ClinicalOMICs.com

Pipeline

*
*
*

Clinical Trials Solution
Integration and Audit for GLP
and 21 CFR Parts 11, 820
Study Manager
Workflow publication
Computer System Validation

* Electronic data
capture (EDC)
* Clinical trial
management
system (CTMS)
http://www.ClinicalOMICs.com
Rise of Genomics in Clinical Trials

Table of Contents for the Digital Edition of Rise of Genomics in Clinical Trials
