WHY DNANEXUS CLINICAL TRIAL SOLUTION?
Bringing a single oncology drug through FDA approval can take over a decade and cost more than $1 billion. By investing in NGS sequencing in early-stage clinical development, later phases can be optimized and de-risked through biomarker-driven participant selection and intervention guidance. DNAnexus CTS combines secondary analysis, interpretation, and translational informatics solutions, on a GxP-compliant, quality managed, audit-friendly, cloud-based Platform-as-a-Service. The same compliant DNAnexus service powers the FDA’s precisionFDA platform for advancing regulatory standards for NGS-based drugs and devices.
HOW IT WORKS
The clinical trial environment of the DNAnexus Platform provides secure and compliant services for storage, analysis and reporting of genomic information. Bioinformaticians can deploy, test, and validate their pipelines and reports in the clinical trial environment. Participant’s DNA samples are sequenced by contract research organizations (CROs) and sequencing service providers and seamlessly uploaded to DNAnexus CTS from anywhere in the world for validated analysis and reporting.
CROs and service providers can track the status of their data and analyses using the CTS service provider web interface. Study physicians monitor the progress of participants analyses using the CTS clinician web interface. DNAnexus CTS is integrated with clinical trial management systems (CTMS) to retrieve and deposit participant sample metadata. Genomic analysis results and reports are sent to study physicians and deposited into the electronic data capture system of record.
ONE PLATFORM FOR ALL YOUR CLINICAL NEEDS
Application & pipeline engineers work in a flexible, unregulated environment, yet with the foundation of security and compliance to enable ready transition to regulated phases.
DNAnexus scientists work with customers to qualify applications and create validated pipelines compliant with GLP and 21 CFR Parts 11 and 820.
DNAnexus scientists work with customers to harden production pipelines in compliance with CAP/CLIA. For NGS-informed manufacturing processes, production pipelines are deployed in compliance with GMP.
Get in touch to have a chat about advancing the use of NGS data in clinical trials.