Our Head of Vulcan James McDermott recently presented on "Navigating ICH11, CDISC and USDM on the path to Digital Protocol." at the PHUSE SDE in Frankfurt. The digital protocol is a hot topic in the industry and a great example of how Vulcan, the industry (via consortia) and the regulatory bodies are coming together to enhance clinical development. If you’d like to learn more about the digital protocol, check out our past webinars from the Utilizing the Digital Protocol (UDP) project. In these sessions, representatives from Vulcan, CDISC, TransCelerate, and regulatory bodies discuss its impact and implementation. Watch them here: (https://lnkd.in/ei78yJ3j) #HL7vulcan #FHIR #Phuse #HL7
关于我们
HL7 FHIR? is the communication standard for exchanging healthcare data being adopted worldwide. Past announcements from the FDA and current developments by the European Union (European Health Data Space, European Medicines Agency: IDMP, Unicom, Gravitate Health ) all prioritize FHIR as the underlying data transmission standard. Vulcan uses a non-competitive development environment to help boost the adoption of FHIR for clinical research. In the 2 years since launch, Vulcan has established 6 active projects, produced 3 implementation guides and now has a membership of over 40 organizations with global presence. Current Vulcan Projects: Vulcan projects are establishing standards across a broad spectrum of clinical research use cases. The first three projects are currently being balloted by HL7 International. 1. ePI: Electronic Product Information In collaboration with Gravitate Health), making Medicinal Product Information machine processable. 2. RWD: Real World Data Setting minimum standards for adoption of the International Patient Summary (IPS) to allow EHR data to be used for Clinical Research 3. SoA: Schedule of Activities Representing the schedule of activities in machine readable format. The basis for full protocol representation. 4. AE: Adverse Events The FHIR AdverseEvent resource has been updated for research; an Implementation Guide is being written for balloting in 2023 5. Phenotypic Data Representation of genomic data in the EHR using HL7 FHIR 6. FHIR to OMOP Establishing a gold standard mapping from the many that exist 7. UDP: Utilizing the Digital Protocol Bringing together multiple initiatives developing a digital representation of a Study Protocol
- 网站
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https://HL7Vulcan.org
HL7 Vulcan的外部链接
- 所属行业
- 非盈利组织
- 规模
- 2-10 人
- 类型
- 非营利机构
HL7 Vulcan员工
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Samir Jain
Product @ Medidata, Interop Nerd
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Abhishek (Abhi) Dabral
Clinical Data Science Leader & Head, Clinical Data Management | Digital Health Technologies | Drug Development & Regulatory Submissions | HBR…
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Lukasz Kaczmarek
Medical Informaticist with a focus on data, interoperability, data science, and machine learning in healthcare. Specialized in leveraging…
动态
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We are pleased to announce the appointment of James McDermott as the new Head of Vulcan, a key role in advancing the growth and development of the HL7 Vulcan accelerator initiative. ? With over 30 years of experience in medical statistics, clinical research, and healthcare data sciences, James brings a wealth of knowledge and leadership to this position. He is recognized as a pioneering figure in the field, having founded and led several successful organizations. His extensive expertise spans leadership, strategic planning, and organizational management, making him an invaluable asset as we continue to enhance the impact of the Vulcan accelerator in accelerating drug development and generating insights into patient care through the seamless integration of clinical and translational research with clinical care. #HL7Vulcan #HL7 #FHIR
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Improving Clinical Research Infrastructure is an important next step for the healthcare ecosystem. More than 30 organizations have come together to demonstrate successful use of Vulcan’s FHIR Implementation Guides and we aim to double that number by the end of the year. ? Stop by our kiosk at HIMSS 2025 next week to learn how you can get involved! #HL7Vulcan #HL7 #FHIR
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Reminder of the Vulcan Utilizing the Digital Protocol webinar tomorrow There is still time to register either by scanning the QR code below or folling this link https://lnkd.in/dhimxNTG
?? Vulcan Webinar series: Utilizing the Digital Protocol ?? ?? Event Date: Tuesday, 11 February 2025 ?? Event Time: 9:00 to 10:15 a.m. EST ?? Registration: QR code on picture or follow the link(https://lnkd.in/eCMqPXd2) During this webinar, our panellists (Hugh Glover #hl7Vulcan, Chris Decker #CDISC , David Iberson-Hurst #CDISC and Mary Lynn Mercado #Transcelerate) will: - Give you insight into the UDP Connectathons—technical events that test development work within business processes.? - Discuss the Schedule of Activities (SoA) as tested during the January 2025 Connectathon, demonstrating the ability to transmit using the SoA message and render on a receiving system as a SoA table (as seen in the protocol document).? - Address the pathway to further digitization and the impact on business processes. If you are new to Vulcan UDP: Check out this?overview video (https://lnkd.in/e7Et_r-2)?for a comprehensive background to the Vulcan UDP project and a summary of our progress. Also Find more about the previous UDP webinars by visiting Vulcan website Event page (https://www.hl7vulcan.org/) #hl7vulcan, #hl7, #fhir, #transcelerate, #CDISC
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?? Vulcan Webinar series: Utilizing the Digital Protocol ?? ?? Event Date: Tuesday, 11 February 2025 ?? Event Time: 9:00 to 10:15 a.m. EST ?? Registration: QR code on picture or follow the link(https://lnkd.in/eCMqPXd2) During this webinar, our panellists (Hugh Glover #hl7Vulcan, Chris Decker #CDISC , David Iberson-Hurst #CDISC and Mary Lynn Mercado #Transcelerate) will: - Give you insight into the UDP Connectathons—technical events that test development work within business processes.? - Discuss the Schedule of Activities (SoA) as tested during the January 2025 Connectathon, demonstrating the ability to transmit using the SoA message and render on a receiving system as a SoA table (as seen in the protocol document).? - Address the pathway to further digitization and the impact on business processes. If you are new to Vulcan UDP: Check out this?overview video (https://lnkd.in/e7Et_r-2)?for a comprehensive background to the Vulcan UDP project and a summary of our progress. Also Find more about the previous UDP webinars by visiting Vulcan website Event page (https://www.hl7vulcan.org/) #hl7vulcan, #hl7, #fhir, #transcelerate, #CDISC
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?? Vulcan Interoperability Bridge Event: A Webinar to Enable Clinical Research Infrastructure ?? REGISTRATION OPEN ?? Vulcan, in coordination with the Assistant Secretary for Technology Policy/ Office of the National Coordinator (ASTP/ONC) and the Food and Drug Administration (FDA), invites you to a webinar for the Vulcan Interoperability Bridge (VIB) event. The VIB event aims to accelerate the adoption of healthcare data standards for research – underscoring the value of using HL7 FHIR? to solve existing challenges and explore novel opportunities in research data interoperability. Join nearly thirty industry organizations who have adopted HL7 Vulcan standards into their systems to enable the clinical research infrastructure. Watch as these Vulcan stakeholders weave together the technical protocols and solutions that will advance cancer use cases, clinical trial readiness projects, health equity, and together build a stronger clinical trials infrastructure. - See these 30 organizations share live demonstrations of pre-pilot implementations using HL7? FHIR? - Join the clinical research community to provide feedback, questions and comments on end to end FHIR workflows - Learn where to find the resources you need to use FHIR APIs to improve data quality, efficiency, and overall cost to conduct research ?? Register now! (https://lnkd.in/eCkU8mSr) Contact the team at [email protected] More information : https://lnkd.in/g4SFWh7r #HL7Vulcan, #HL7FHIR, #interoperability, #clinicalresearch, #HL7 Health Level Seven International
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?? Job Opportunity ?? Check the attached document for more details If you are interested, you should submit your proposal via e-mail to: [email protected]
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Here is a great opportunity to join HL7 CodeX Community of Practice to learn about the successful work of two of their use case teams: Quality Measures for Cancer, and EHR Endpoints for Cancer Clinical Trials. https://lnkd.in/g8Qda8iF Remember to register to the event (details in the event or follow this link: https://lnkd.in/gha568eE)
You're invited to join us for the CodeX Community of Practice call on Friday December 13, 2024. As a participant, you'll learn all about the excellent ongoing work of the Quality Measures for Cancer team: https://lnkd.in/g9eCZ2ad We will also be celebrating the successful conclusion of the ICAREdata project (EHR Endpoints for Cancer Clinical Trials) as they officially close out their use case. We will hear about their learnings and some of the impact that this project is having in the ecosystem. https://lnkd.in/gKAPQvkK Please register for the Zoom webinar here: https://lnkd.in/gZwvvYNg #HL7 #codex #fhir Mael Priour, Michelle Casagni, Nicole Llewellyn, Gail Shenk, Doug Williams, Su (Sutin) Chen, Saneel Vasram, Susan Rand
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Join us to learn about?Vulcan’s Utilizing the Digital Protocol (UDP), an umbrella project accelerating ICH M11 and end-user value. The protocol agreed upon between the sponsor and regulator governs all aspects of a clinical trial. ICH M11/M2, CDISC, and TransCelerate are working toward a digital form of the protocol. Vulcan UDP is bringing those components together into an FHIR-based exchange to ensure the protocol's interoperability across stakeholders. ? During this webinar, our panellists will: ? - Provide a brief background of the UDP project, with additional details available in the July webinar recording (https://lnkd.in/e5WPPvve). - Give you insight into the UDP Connectathons—technical events that test development work within business processes. The focus will be on study-level elements of the title page, eligibility criteria, objectives/endpoints/estimations, and opportunities to participate in future Connectathons.?? - Discuss the practical steps to prepare for implementation.? Also Find more about the previous UDP webinars by visiting Vulcan website Event page (https://www.hl7vulcan.org/) #hl7vulcan #hl7 #fhir #transcelerate #CDISC #Eli
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