REDWOOD SHORES, Calif., Oct. 23,
2019 /PRNewswire/ -- Oracle Health Sciences, a leader in
eClinical technology and Phlexglobal, pioneers in the provision of
Trial Master File (TMF) technology and services for the global life
sciences industry, have announced enhanced integrations to
accelerate the 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
automation to streamline processes, has an open architecture to
ensure easy data integration, and provides advanced 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 seamless and 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 – the
TMF Reference Model is now widely adopted as the TMF structure of
choice. In addition, the group has developed an exchange mechanism
for vendor interoperability. This critical 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).
Phlexglobal and Oracle representatives will be available to
discuss this collaboration at:
- Phlexglobal TMF World Forum & User Conference
(Beaconsfield, UK)
-
- Nov. 12-13
- https://www.phlexglobal.com/2019-tmf-world-forum-uk
- 9th US Trial Master File Summit TMF Summit
(Orlando, FL)
-
- Jan. 21-23
- https://tmfsummit.com/us
About Phlexglobal
Phlexglobal are world-renowned
thought leaders and specialists in the provision of electronic
Trial Master File (eTMF) systems and services. They offer a unique
combination of eTMF technology with PhlexEview – their market
leading eTMF system, quality services and specialist resource that
delivers a range of flexible, targeted solutions to meet your
business needs. Phlexglobal is headquartered in the UK, with
offices in Malvern, PA, Durham,
NC, and Lublin, Poland.
About Oracle Health Sciences
Oracle Health Sciences
breaks down barriers and opens new pathways to unify people and
processes to bring new drugs to market faster. As a leader in Life
Sciences technology, Oracle Health Sciences is trusted by 30 of the
top 30 pharma, 10 of the top 10 biotech and 10 of the top 10 CROs
for managing clinical trials and pharmacovigilance around the
globe.
About Oracle
The Oracle Cloud offers a complete suite
of integrated applications for Sales, Service, Marketing, Human
Resources, Finance, Supply Chain and Manufacturing, plus Highly
Automated and Secure Generation 2 Infrastructure featuring the
Oracle Autonomous Database. For more information about Oracle
(NYSE: ORCL), please visit us at www.oracle.com.
Trademarks
Oracle and Java are registered trademarks
of Oracle and/or its affiliates. Other names may be trademarks of
their respective owners.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/oracle-health-sciences-and-phlexglobal-collaborate-to-reduce-operational-bottlenecks-in-clinical-research-300943695.html
SOURCE Oracle