Oracle Health Sciences and Trial Master File (TMF) technology provider Phlexglobal have collaborated to accelerate the speed and accuracy of regulatory compliance, as well as inspection readiness in clinical trials.
A TMF is a requirement that should be satisfied by all sponsors and contract research organisations (CROs) to assure that the rights, safety and well-being of trial participants are protected.
CROs and sponsors should also check if the trials are being conducted in accordance with good clinical practice (GCP) principles, and enhance the audit readiness of clinical data.
Oracle Health Sciences noted that Phlexglobal’s PhlexEview TMF management system uses automation to streamline processes.
The TMF system has an open architecture to ensure easy data integration, and provides advanced functionality designed to facilitate TMF Management in a more efficient manner.
Phlexglobal CEO John McNeill said: “Our integration with Oracle Health Sciences’ industry-leading applications will save organisations significant resources, as documents only have to be checked once early in the process, which will ensure that any issues can be found and corrected in a timely manner enhancing overall quality.
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“Our life science customers will be able to leverage industry KPIs to support business process optimisation and business intelligence in clinical study startup, strengthening our regulatory compliance and global trial oversight capabilities.”
The Oracle Health Sciences eClinical platform, when integrated with the TMF, provides an advanced clinical trial ecosystem for life sciences companies.
Oracle Health Sciences life sciences product strategy global vice-president James Streeter said: “Adoption of industry standards is critical to plug-and-play coexistence in the eClinical ecosystem.
“What’s required is a deep understanding of the right type of integration at the right time for the different integration points.
“The TMF Reference Model Exchange Mechanism facilitates these integrations by providing a common language amongst all eClinical vendors. We strongly support this initiative.”