Oracle Health Sciences, Clinical technology provider and Phlexglobal, provider of Trial Master File (TMF) technology and services for the global life sciences industry, have announced enhanced integrations designed to speed and accuracy of regulatory compliance and inspection readiness in clinical trials.

A TMF is a requirement that all sponsors and contract research organizations (CROs) must meet to assure that the rights, safety and well-being of trial subjects are protected, that their trials are being conducted in accordance with Good Clinical Practice (GCP) principles, and that the clinical trial data is credible to ensure audit readiness.

Phlexglobal’s PhlexEview TMF management system uses, has an open architecture to ensure easy data integration, and provides functionality designed to better facilitate TMF Management.

The Oracle Health Sciences eClinical platform, integrated with the TMF, provides a comprehensive, proven and best-in-class clinical trial ecosystem for life science organizations. Oracle Health Sciences provides key integration components (i.e., data staging, business rule compliance, target data staging, and API processing) to ensure  successful integrations with its applications.

Standards are critical

Other eClinical solutions only support clinical trial functions in silos. The ability to bring together the collective institutional memory and the facilitation between systems and team members is critical, and addresses an unmet need. The challenges in integration of eClinical systems stem from the lack of standards.

Phlexglobal’s Chief Strategy Officer Karen Roy is highly active in the TMF Reference Model, an industry-led initiative to define these standards. In addition, the group has developed an exchange mechanism for vendor interoperability. This initiative establishes a common language (both business and technical exchange mechanism) enabling different organizational departments and companies to automate the exchange of information, which satisfies end-to-end requirements and validation.

The adoption of industry standards is critical to plug-and-play coexistence in the eClinical ecosystem and what is 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. Eliminating inefficiencies and bottlenecks associated with disparate data silos is critical to the goal of reducing cycle times in clinical trials. Today, regulatory authorities are placing more emphasis on contemporariness and timeliness of the TMF content they receive from sponsors and CROs. To achieve this, it is critical to ensure and document most of the content quality, as specified in the ALCOA-C guidance, prior to the content being transferred to the TMF. Together, Oracle Health Sciences and Phlexglobal address this challenge.  

“Our integration with Oracle Health Sciences’ industry-leading applications will save organizations 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,” said John McNeill, CEO of Phlexglobal. “Our collaboration represents a leap forward in improving clinical trials and controlling runaway costs and timelines. Our life science customers will be able to leverage industry KPIs to support business process optimization and business intelligence in clinical study startup, strengthening our regulatory compliance and global trial oversight capabilities.”

“Adoption of industry standards is critical to plug-and-play coexistence in the eClinical ecosystem,” said James Streeter, global vice president life sciences product strategy, Oracle Health Sciences. “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.”

Phlexglobal is a Silver level member of Oracle PartnerNetwork (OPN).