Click here to close now.




















Welcome!

@ThingsExpo Authors: Pat Romanski, Bob Gourley, Elizabeth White, Joe Pruitt, Kevin Jackson

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.

@ThingsExpo Stories
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducted a live demonstration of how quickly application development can happen when the need to comply wit...
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Architect for the Internet of Things and Intelligent Systems, described how to revolutionize your archit...
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with APIs within the next year.
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, d...
In his keynote at 16th Cloud Expo, Rodney Rogers, CEO of Virtustream, discussed the evolution of the company from inception to its recent acquisition by EMC – including personal insights, lessons learned (and some WTF moments) along the way. Learn how Virtustream’s unique approach of combining the economics and elasticity of the consumer cloud model with proper performance, application automation and security into a platform became a breakout success with enterprise customers and a natural fit for the EMC Federation.
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of profound change in the industry.
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affect their organization.
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world and it starts with business models and monetization strategies.
Converging digital disruptions is creating a major sea change - Cisco calls this the Internet of Everything (IoE). IoE is the network connection of People, Process, Data and Things, fueled by Cloud, Mobile, Social, Analytics and Security, and it represents a $19Trillion value-at-stake over the next 10 years. In her keynote at @ThingsExpo, Manjula Talreja, VP of Cisco Consulting Services, discussed IoE and the enormous opportunities it provides to public and private firms alike. She will share what businesses must do to thrive in the IoE economy, citing examples from several industry sectors.
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not the disruptee.
Akana has released Envision, an enhanced API analytics platform that helps enterprises mine critical insights across their digital eco-systems, understand their customers and partners and offer value-added personalized services. “In today’s digital economy, data-driven insights are proving to be a key differentiator for businesses. Understanding the data that is being tunneled through their APIs and how it can be used to optimize their business and operations is of paramount importance,” said Alistair Farquharson, CTO of Akana.
Business as usual for IT is evolving into a "Make or Buy" decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud business applications and services across multiple cloud delivery models.
The enterprise market will drive IoT device adoption over the next five years. In his session at @ThingsExpo, John Greenough, an analyst at BI Intelligence, division of Business Insider, analyzed how companies will adopt IoT products and the associated cost of adopting those products. John Greenough is the lead analyst covering the Internet of Things for BI Intelligence- Business Insider’s paid research service. Numerous IoT companies have cited his analysis of the IoT. Prior to joining BI Intelligence, he worked analyzing bank technology for Corporate Insight and The Clearing House Payment...
"Optimal Design is a technology integration and product development firm that specializes in connecting devices to the cloud," stated Joe Wascow, Co-Founder & CMO of Optimal Design, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
SYS-CON Events announced today that CommVault has been named “Bronze Sponsor” of SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. A singular vision – a belief in a better way to address current and future data management needs – guides CommVault in the development of Singular Information Management® solutions for high-performance data protection, universal availability and simplified management of data on complex storage networks. CommVault's exclusive single-platform architecture gives companies unp...
Electric Cloud and Arynga have announced a product integration partnership that will bring Continuous Delivery solutions to the automotive Internet-of-Things (IoT) market. The joint solution will help automotive manufacturers, OEMs and system integrators adopt DevOps automation and Continuous Delivery practices that reduce software build and release cycle times within the complex and specific parameters of embedded and IoT software systems.
"ciqada is a combined platform of hardware modules and server products that lets people take their existing devices or new devices and lets them be accessible over the Internet for their users," noted Geoff Engelstein of ciqada, a division of Mars International, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Internet of Things is moving from being a hype to a reality. Experts estimate that internet connected cars will grow to 152 million, while over 100 million internet connected wireless light bulbs and lamps will be operational by 2020. These and many other intriguing statistics highlight the importance of Internet powered devices and how market penetration is going to multiply many times over in the next few years.