|By Business Wire||
|March 20, 2014 10:44 AM EDT||
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
“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
"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
OASIS eTMF Technical Committee
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.
Puppet Labs has announced the next major update to its flagship product: Puppet Enterprise 2015.2. This release includes new features providing DevOps teams with clarity, simplicity and additional management capabilities, including an all-new user interface, an interactive graph for visualizing infrastructure code, a new unified agent and broader infrastructure support.
Aug. 29, 2015 03:00 AM EDT Reads: 459
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Aug. 28, 2015 11:45 PM EDT Reads: 400
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.
Aug. 28, 2015 11:30 PM EDT Reads: 825
Red Hat is investing in Tesora, the number one contributor to OpenStack Trove Database as a Service (DBaaS) also ranked among the top 20 companies contributing to OpenStack overall. Tesora, the company bringing OpenStack Trove Database as a Service (DBaaS) to the enterprise, has announced that Red Hat and others have invested in the company as a part of Tesora's latest funding round. The funding agreement expands on the ongoing collaboration between Tesora and Red Hat, which dates back to Febr...
Aug. 28, 2015 09:00 PM EDT Reads: 290
As more and more data is generated from a variety of connected devices, the need to get insights from this data and predict future behavior and trends is increasingly essential for businesses. Real-time stream processing is needed in a variety of different industries such as Manufacturing, Oil and Gas, Automobile, Finance, Online Retail, Smart Grids, and Healthcare. Azure Stream Analytics is a fully managed distributed stream computation service that provides low latency, scalable processing of ...
Aug. 28, 2015 07:45 PM EDT Reads: 174
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Aug. 28, 2015 06:00 PM EDT Reads: 311
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and a...
Aug. 28, 2015 05:30 PM EDT Reads: 405
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Trel...
Aug. 28, 2015 03:45 PM EDT Reads: 168
Cloud and datacenter migration innovator AppZero has joined the Microsoft Enterprise Cloud Alliance Program. AppZero is a fast, flexible way to move Windows Server applications from any source machine – physical or virtual – to any destination server, in any cloud or datacenter, using its patented container technology. AppZero’s container is also called a Virtual Application Appliance (VAA). To facilitate Microsoft Azure onboarding, AppZero has two purpose-built offerings: AppZero SP for Azure,...
Aug. 28, 2015 03:15 PM EDT
WSM International, the pioneer and leader in server migration services, has announced an agreement with WHOA.com, a leader in providing secure public, private and hybrid cloud computing services. Under terms of the agreement, WSM will provide migration services to WHOA.com customers to relocate some or all of their applications, digital assets, and other computing workloads to WHOA.com enterprise-class, secure cloud infrastructure. The migration services include detailed evaluation and planning...
Aug. 28, 2015 03:01 PM EDT
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
Aug. 28, 2015 02:15 PM EDT Reads: 412
A producer of the first smartphones and tablets, presenter Lee M. Williams will talk about how he is now applying his experience in mobile technology to the design and development of the next generation of Environmental and Sustainability Services at ETwater. In his session at @ThingsExpo, Lee Williams, COO of ETwater, will talk about how he is now applying his experience in mobile technology to the design and development of the next generation of Environmental and Sustainability Services at ET...
Aug. 28, 2015 02:00 PM EDT
SYS-CON Events announced today the Containers & Microservices Bootcamp, being held November 3-4, 2015, in conjunction with 17th Cloud Expo, @ThingsExpo, and @DevOpsSummit at the Santa Clara Convention Center in Santa Clara, CA. This is your chance to get started with the latest technology in the industry. Combined with real-world scenarios and use cases, the Containers and Microservices Bootcamp, led by Janakiram MSV, a Microsoft Regional Director, will include presentations as well as hands-on...
Aug. 28, 2015 12:30 PM EDT Reads: 124
SYS-CON Events announced today that Micron Technology, Inc., a global leader in advanced semiconductor systems, 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. Micron’s broad portfolio of high-performance memory technologies – including DRAM, NAND and NOR Flash – is the basis for solid state drives, modules, multichip packages and other system solutions. Backed by more than 35 years of tech...
Aug. 28, 2015 12:30 PM EDT Reads: 146
This Enterprise Strategy Group lab validation report of the NEC Express5800/R320 server with Intel® Xeon® processor presents the benefits of 99.999% uptime NEC fault-tolerant servers that lower overall virtualized server total cost of ownership. This report also includes survey data on the significant costs associated with system outages impacting enterprise and web applications. Click Here to Download Report Now!
Aug. 28, 2015 12:30 PM EDT