Welcome!

News Feed Item

Pharmaceutical and IT Communities Collaborate on OASIS Clinical Trial Data Standard for Content Management Systems

The pharmaceutical community, health care organizations, and software providers are coming together at the OASIS open standards consortium to define a machine-readable content classification standard for the interoperable exchange of clinical trial data via content management systems. The work of the new OASIS Electronic Trial Master File (eTMF) Standard Technical Committee will promote interoperability across diverse computing platforms and cloud networks within the clinical trials community.

“We’re responding to a growing global need for a technology standard that can support formal representation and exchange of clinical trials eTMF content. Our goal is to enhance information interoperability among stakeholders,” said Zack Schmidt of SureClinical, chair of the OASIS eTMF Standard Technical Committee. “The breadth and stature of the organizations advancing this work clearly indicate there’s a real need for this standard.”

The OASIS eTMF work will enable content to be exchanged through cloud, networks, or physical media. Members will define an eTMF content classification model (including a standards-based vocabulary and content classification ontology), a set of content classification policies, and an eTMF Data Model.

The eTMF Standard framework will be a 'standard based on standards.’ It will support required documents from multiple regulatory agencies, published vocabulary references, and key industry standards. The OASIS work will be take place in two phases. The technology phase will build on the content classification specification and core terms contributed to OASIS by CareLex with input from the National Cancer Institute’s Enterprise Vocabulary Services. The vocabulary phase will build on the TMF Reference Model produced by the Document and Records Management DIA Community. It will utilize a W3C semantic web-based ontology to classify content as well as a controlled vocabulary sourced primarily from the NCI Thesaurus, which includes terms from the Biomedical Research Integrated Domain Group (BRIDG) Model, the product of a collaboration among CDISC, NCI, HL7, and the U.S. FDA. Additional eTMF domain classification terms, some of which are not present in BRIDG, will be developed by the OASIS Technical Committee.

New members are encouraged to join the OASIS eTMF Standard Technical Committee at any time. Archives of the work are accessible to both members and non-members, and OASIS invites public review and comment on the work.

Support for OASIS eTMF Standard

Forte Research Systems
“As a provider of specialized software serving organizations engaged in clinical and translational research, Forte Research Systems is committed to the development and adoption of relevant technology standards like eTMF and to supporting the work of standards organizations like OASIS. We are particularly enthusiastic about this new OASIS effort because it promises a consistent organization and structure of TMF content enabling the exchange of common TMF elements with other software systems in this space.”
--Tony O'Hare, PhD, Co-Founder, VP Operations, & Chief Collaboration Office, Forte Research

Health Level Seven (HL7)
“HL7 is pleased to continue its collaborative efforts with OASIS by participating in the Electronic Trial Master File (eTMF) Standard. This initiative to support formal representation and exchange of clinical trials eTMF information is well aligned with the existing standard that was jointly developed by HL7 and CDISC for the Regulated Clinical Research Information Management (RCRIM) Biomedical Research Integrated Domain Group’s Domain Analysis Model for the clinical research domain and also leverages a long standing HL7 relationship with not only CDISC and OASIS but also the FDA and NLM.”
--John Quinn, CTO, HL7

Oracle
“As a leading provider of life science solutions, Oracle recognizes that developing standards to support data exchange and interoperability is critical to the smooth flow of data between systems that participate in the clinical trial life cycle. The ability for eTMF systems to easily consume Trial Master File documents and exchange those documents seamlessly will greatly improve sponsor management of trial documentation and speed up preparation of trial artifacts used in regulatory submissions. Oracle is pleased to participate in this initiative.”
--Don Deutsch, VP, Chief Standards Officer, Oracle

SureClinical
"As a founding sponsor of the OASIS eTMF Technical Committee, SureClinical is excited to see the widespread industry adoption of OASIS open standards. As a provider of cloud-based eTMF applications, we are proud to partner in the development of this critical BioPharma initiative that accelerates delivery of new therapies globally by facilitating the paperless exchange of clinical trial content. We look forward to championing the OASIS eTMF Standard by implementing a compliant SureTrial® eTMF Cloud solution."
--Zachariah Schmidt, CEO, SureClinical

Additional information

OASIS eTMF Technical Committee
https://www.oasis-open.org/committees/etmf/

About OASIS:

OASIS is a non-profit, international consortium that drives the development, convergence and adoption of open standards for the global information society. OASIS promotes industry consensus and produces worldwide standards for cloud computing, content technologies, security, privacy, M2M, IoT, energy, and other areas. OASIS open standards offer the potential to lower cost, stimulate innovation, grow global markets, and protect the right of free choice of technology. OASIS members broadly represent the marketplace of public and private sector technology leaders, users, and influencers. The consortium has more than 5,000 participants representing over 600 organizations and individual members in 65+ countries.
http://www.oasis-open.org

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discussed how businesses can gain an edge over competitors by empowering consumers to take control through IoT. He cited examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He also highlighted how IoT can revitalize and restore outdated business models, making them profitable ...
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
SaaS companies can greatly expand revenue potential by pushing beyond their own borders. The challenge is how to do this without degrading service quality. In his session at 18th Cloud Expo, Adam Rogers, Managing Director at Anexia, discussed how IaaS providers with a global presence and both virtual and dedicated infrastructure can help companies expand their service footprint with low “go-to-market” costs.
Get deep visibility into the performance of your databases and expert advice for performance optimization and tuning. You can't get application performance without database performance. Give everyone on the team a comprehensive view of how every aspect of the system affects performance across SQL database operations, host server and OS, virtualization resources and storage I/O. Quickly find bottlenecks and troubleshoot complex problems.
"We are the public cloud providers. We are currently providing 50% of the resources they need for doing e-commerce business in China and we are hosting about 60% of mobile gaming in China," explained Yi Zheng, CPO and VP of Engineering at CDS Global Cloud, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Predictive analytics tools monitor, report, and troubleshoot in order to make proactive decisions about the health, performance, and utilization of storage. Most enterprises combine cloud and on-premise storage, resulting in blended environments of physical, virtual, cloud, and other platforms, which justifies more sophisticated storage analytics. In his session at 18th Cloud Expo, Peter McCallum, Vice President of Datacenter Solutions at FalconStor, discussed using predictive analytics to mon...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and sh...
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
IoT is rapidly changing the way enterprises are using data to improve business decision-making. In order to derive business value, organizations must unlock insights from the data gathered and then act on these. In their session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, and Peter Shashkin, Head of Development Department at EastBanc Technologies, discussed how one organization leveraged IoT, cloud technology and data analysis to improve customer experiences and effici...
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, contrasted how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He showed how the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He also demoed building immutable pipelines in the cloud ...