Welcome!

News Feed Item

TMF Reference Model Exchange Mechanism Standard Bridges Disparate Clinical Data Silos

goBalto spearheads initiative to bring standardization to the eClinical stack

SAN FRANCISCO, June 14, 2018 /PRNewswire/ -- goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today its fully integrated framework, compliant with the TMF reference model (version 3.0) XML-based exchange mechanism, is also pending compliance with the new Exchange Mechanism Standard, a first for any non-TMF vendor.

goBalto logo. (PRNewsFoto/goBalto, Inc.)

The TMF (Trial Master File) Reference Model provides an opportunity for standardization across the clinical trials industry by providing standardized taxonomy and metadata and outlining a reference definition of TMF content using standard nomenclature. As such, the model is a valuable tool for any organization engaged in clinical trials, including technology providers. The new Exchange Mechanism Standard enables vendors to build an exchange component, which standardizes all TMF related content and metadata exchanged, ensuring focus on the business value of the exchange rather than API calls and vendor management.

The vendor community is invited to participate in a review and discussion at the launch of the standard (https://tmfrefmodel.com/2018/05/31/etmf-ems-launch/), held in conjunction with the DIA Annual Meeting. Elvin Thalund, goBalto's Senior Director of Industry Strategy and co-chair of the TMF Reference Model Exchange Group will be presenting, "Bridging Regulatory Quality and Operational Efficiency with the Exchange Standard."

"Previously, eClinical system integration was left to sponsors and CROs to figure out with multiple vendors. What the TMF exchange mechanism offers is a real opportunity for vendors to get together to proactively solve the integration needs of their customers," said Thalund.

Existing systems (CTMS, eTMF, Study/Investigator Portals, etc.) 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, representing an unmet need. The challenges in integration of eClinical systems stems from the lack of standards, it's simply not enough to have APIs available.

"The TMF exchange format is pivotal and sets the stage for integrations across the whole eClinical stack. The TMF exchange (e.g., standard conventions for file naming and long-term TMF storage formats) has far reaching consequences," said Eldin Rammell, member of TMF Reference Model, Exchange Subgroup and TMF expert. Paul Fenton, co-chair of TMF Reference Model Exchange Group added, "Establishing a TMF exchange format is about creating a platform and process open enough so it can be used by all eClinical vendors."

Eliminating inefficiencies and bottlenecks associated with disparate data silos is critical to the goal of reducing cycle times in clinical trials. Each tool – eTMF, CTMS, and Study Startup – plays a distinct role in optimizing the full clinical trials process; each performs separate functions but serves overlapping user groups.

"True integration is critical to plug and play coexistence in the eClinical stack," said Sujay Jadhav, goBalto's CEO. "What's required is a deep understanding of the right type of integration at the right time for the different integration points. The TMF exchange format will facilitate these integrations by providing a common language amongst all eClinical vendors. We strongly support this initiative."

About the TMF Reference Model
The TMF Reference Model, a DIA Document and Records Management Community project, provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. The Model is not intended to be taken and used "off-the-shelf" but can be adapted to an electronic or paper TMF, and does not endorse, nor require, any specific technology for application. DIA members and industry members are under no obligation to adopt the TMF Reference Model. To learn more, visit www.tmfrefmodel.com.

About goBalto
goBalto is the industry leader in cloud-based study startup software for the global life sciences industry, offering the only complete end-to-end platform for starting clinical trials, from site identification, feasibility assessment and selection through to activation, with comprehensive metrics to track adherence to timelines and budget. Committed to accelerating clinical trials through innovation, product excellence, and customer success, goBalto works with four of the top five CROs and more than two-thirds of the top 25 pharmas. Our customers include: Allergan, Covance, CMIC HOLDINGS, Genentech Roche, ICON, Novartis, PSI CRO, Syneos Health, TFS International, and Worldwide Clinical Trials. goBalto is headquartered in San Francisco, with offices in Philadelphia and Singapore. For more information, visit www.gobalto.com.

Press contact:
Craig Morgan
415.671.4372
[email protected]

 

Cision View original content with multimedia:http://www.prnewswire.com/news-releases/tmf-reference-model-exchange-mechanism-standard-bridges-disparate-clinical-data-silos-300666093.html

SOURCE goBalto, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
When talking IoT we often focus on the devices, the sensors, the hardware itself. The new smart appliances, the new smart or self-driving cars (which are amalgamations of many ‘things'). When we are looking at the world of IoT, we should take a step back, look at the big picture. What value are these devices providing. IoT is not about the devices, its about the data consumed and generated. The devices are tools, mechanisms, conduits. This paper discusses the considerations when dealing with the...
SYS-CON Events announced today that IoT Global Network has been named “Media Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. The IoT Global Network is a platform where you can connect with industry experts and network across the IoT community to build the successful IoT business of the future.
DXWorldEXPO LLC announced today that Kevin Jackson joined the faculty of CloudEXPO's "10-Year Anniversary Event" which will take place on November 11-13, 2018 in New York City. Kevin L. Jackson is a globally recognized cloud computing expert and Founder/Author of the award winning "Cloud Musings" blog. Mr. Jackson has also been recognized as a "Top 100 Cybersecurity Influencer and Brand" by Onalytica (2015), a Huffington Post "Top 100 Cloud Computing Experts on Twitter" (2013) and a "Top 50 C...
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
When applications are hosted on servers, they produce immense quantities of logging data. Quality engineers should verify that apps are producing log data that is existent, correct, consumable, and complete. Otherwise, apps in production are not easily monitored, have issues that are difficult to detect, and cannot be corrected quickly. Tom Chavez presents the four steps that quality engineers should include in every test plan for apps that produce log output or other machine data. Learn the ste...
To Really Work for Enterprises, MultiCloud Adoption Requires Far Better and Inclusive Cloud Monitoring and Cost Management … But How? Overwhelmingly, even as enterprises have adopted cloud computing and are expanding to multi-cloud computing, IT leaders remain concerned about how to monitor, manage and control costs across hybrid and multi-cloud deployments. It’s clear that traditional IT monitoring and management approaches, designed after all for on-premises data centers, are falling short in ...
Evan Kirstel is an internationally recognized thought leader and social media influencer in IoT (#1 in 2017), Cloud, Data Security (2016), Health Tech (#9 in 2017), Digital Health (#6 in 2016), B2B Marketing (#5 in 2015), AI, Smart Home, Digital (2017), IIoT (#1 in 2017) and Telecom/Wireless/5G. His connections are a "Who's Who" in these technologies, He is in the top 10 most mentioned/re-tweeted by CMOs and CIOs (2016) and have been recently named 5th most influential B2B marketeer in the US. H...
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Machine learning has taken residence at our cities' cores and now we can finally have "smart cities." Cities are a collection of buildings made to provide the structure and safety necessary for people to function, create and survive. Buildings are a pool of ever-changing performance data from large automated systems such as heating and cooling to the people that live and work within them. Through machine learning, buildings can optimize performance, reduce costs, and improve occupant comfort by ...
When building large, cloud-based applications that operate at a high scale, it's important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. "Fly two mistakes high" is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Le...
CloudEXPO New York 2018, colocated with DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City and will bring together Cloud Computing, FinTech and Blockchain, Digital Transformation, Big Data, Internet of Things, DevOps, AI, Machine Learning and WebRTC to one location.
Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settlement products to hedge funds and investment banks. After, he co-founded a revenue cycle management company where he learned about Bitcoin and eventually Ethereal. Andrew's role at ConsenSys Enterprise is a mul...
DXWorldEXPO | CloudEXPO are the world's most influential, independent events where Cloud Computing was coined and where technology buyers and vendors meet to experience and discuss the big picture of Digital Transformation and all of the strategies, tactics, and tools they need to realize their goals. Sponsors of DXWorldEXPO | CloudEXPO benefit from unmatched branding, profile building and lead generation opportunities.
Daniel Jones is CTO of EngineerBetter, helping enterprises deliver value faster. Previously he was an IT consultant, indie video games developer, head of web development in the finance sector, and an award-winning martial artist. Continuous Delivery makes it possible to exploit findings of cognitive psychology and neuroscience to increase the productivity and happiness of our teams.
Digital transformation has increased the pace of business creating a productivity divide between the technology haves and have nots. Managing financial information on spreadsheets and piecing together insight from numerous disconnected systems is no longer an option. Rapid market changes and aggressive competition are motivating business leaders to reevaluate legacy technology investments in search of modern technologies to achieve greater agility, reduced costs and organizational efficiencies. ...