Rise of Genomics in Clinical Trials - 8

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

The CTS provides for NGS-adaptive trial designs
by supporting iterative development, qualification, and lock-down of pipelines used during the
clinical trial. DNAnexus scientists qualify bioinformatic applications, performing installation,
operation, and performance qualification (IQ/OQ/
PQ). Customers then build validated pipelines
from those qualified applications. DNAnexus
provides customers with evidence of control
for the audited DNAnexus Quality Management
System, which is required to comply with
regulations governing clinical trials.
While customers' Electronic Data Capture (EDC)
and Clinical Trials Management Systems (CTMS)
remain the systems of record, integration with
the CTS enables these systems to hand off
large-scale data management and analysis to
the CTS, which has been optimized to handle the
terabytes of genomic and clinical data that will
be generated throughout the course of the trial.
The CTS API enables integration with sequencing
labs, laboratory information management
systems (LIMS), EDC, and CTMS.

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Rise of Genomics in Clinical Trials

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