Early Bird Ends Friday, 23 August! CDISC is headed to the Western United States for its flagship US Interchange! Join us in sunny Scottsdale, Arizona for innovative presentations, networking opportunities, and interactive training and workshops. This year’s conference features an expanded 5-track agenda with 30+ sessions for two days of cutting-edge insights and innovations shaping the future of CDISC clinical data standards and the Trial Master File. Registration is open! https://lnkd.in/ejKy_Gqz
About us
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org
- Website
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https://www.cdisc.org/
External link for CDISC
- Industry
- Non-profit Organizations
- Company size
- 11-50 employees
- Headquarters
- Austin, TX
- Type
- Nonprofit
- Founded
- 1998
- Specialties
- Clinical Research Data Standards
Locations
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Primary
Get directions
401 West 15th Street
Suite 800
Austin, TX 78701, US
Employees at CDISC
Updates
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Read the latest on the Task Force within the CDISC Advisory Council (CAC) and how their efforts mark a significant enhancement in stakeholder engagement, providing a valuable forum for early input and acceptance of proposed standards. The Task Force's evaluation of the proposed changes to the Study Data Tabulation Model Implementation Guide (SDTMIG) 4.0 underscores the importance of this early engagement. #cleardataclearimpact
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Program Announced for the US+TMF Interchange! This year's US Interchange, happening 23-24 October in beautiful Scottsdale, AZ, brings CDISC Standards content and TMF presentations to the podium from an impressive lineup of subject matter experts who will delve into the latest trends and innovations. The program provides a versatile experience, allowing attendees to focus on specialized topics, mix subjects, and participate in standards-related workshops. View the online program now! https://lnkd.in/gnByUH52
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Join CDISC's Chris Decker and industry partners for tomorrow's webinar, "Vulcan UDP (Utilizing the Digital Protocol): Collaborating to Accelerate ICH M11 and End User Value". Register here: https://lnkd.in/e3DH68xU
Don't miss out! You have only two days left to register for the highly anticipated collaborative webinar with TransCelerate, HL7 Vulcan, and CDISC for the "Vulcan UDP (Utilizing the Digital Protocol): Collaborating to Accelerate ICH M11 and End User Value" session. The panelists will outline UDP's goals, discuss M11's potential impact, and announce the date of the 2024 UDP Connectathon! Panelists: Hugh Glover, Technical Director, Vulcan Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis Chris Decker, President and CEO, CDISC Ron Fitzmartin, Senior Advisor, Office of Regulatory Operations, CBER FDA Noémie Manent, Clinical Trial Transformation Change Manager, EMA Register before Thursday: https://lnkd.in/e3DH68xU.
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We are thrilled to feature Deborah Shepard, Ph.D., in our Volunteer Spotlight, celebrating her commitment as a crucial part of the Genomics Subteam since May 2022! Deborah advises new CDISC volunteers to "be open to learn from other team members and to share your knowledge and experience. You’ll be amazed at the synergy that takes place when we bring our ideas together. I learn something new in every meeting and appreciate the opportunity to advance data standards for the larger community".
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CDISC reposted this
Looking forward to participating in this joint collaborative webinar with TransCelerate BioPharma Inc., CDISC, and HL7 Vulcan on how we are moving digital protocol forward!
Vulcan Utilizing the Digital Protocol webinar - an HL7 Vulcan project - The date is fast approaching 📢 REMINDER TO REGISTER 📢 Full panel is now confirmed 📢 PANELIST: Hugh Glover - #HL7Vulcan Mary Lynn Mercado - #novartis Chris Decker - #CDISC Ron Fitzmartin - #FDA Noémie Manent - #EMA WHEN: 11 July 2024 - 09.00 - 10.30 am Eastern Time The agenda for this webinar is now available, key topics are: • Outline the goals of the UDP project, • Deliver a summary of the first UDP Connectathon • Describe the intent and potential impact of the digital protocol • Announce the upcoming UDP Connectathon in September • Facilitate a Q&A session, #HL7Vulcan, #hl7, #FHIR, #cdisc #ICH, #CeSHARP, #TransCelerate, WHO can attend: anyone interested in Clinical Data Interoperability, Sponsor and CROs involved in processes that consume protocol information, Health authorities, Please for more information and registration follow the link below https://lnkd.in/e3DH68xU (or the QR code in the picture)
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Last Call For China Interchange Abstracts Don't miss the 14 June deadline! Your experience, research and ideas can help shape the future — and CDISC’s China Interchange provides the perfect platform for sharing your expertise. With an abstract of 500 words or less, you can increase your exposure and recognition across the Chinese and global standards community, while providing valuable information that can help today’s implementers make more informed decisions that impact patient outcomes. Start now, with just one paragraph on: - Novelty in Clinical Trials - Real-world Data / Evidence - CDISC in Academic Research - Open Source Usage - Digital Data Flow - Global Regulatory Submissions The China Call for Abstracts will close end of day Friday, 14 June. Please visit the Abstract Submission Page for the complete list of suggested topics, instructions, and the online form. https://lnkd.in/eANF-kR9
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CDISC in partnership with TransCelerate BioPharma Inc. is excited to announce a Call for Abstracts for two upcoming opportunities from the Digital Data Flow (DDF) initiative to showcase technology solutions for clinical study protocol digitalization. For more information to submit an abstract: https://lnkd.in/e5Na9eK9 #cleardataclearimpact
Digital Data Flow (DDF) is making tracks! Submit your abstracts before 19 July for two upcoming events: the DDF Vendor Showcase on 26 September, a webinar where solution providers can share a 30-minute presentation of protocol digitalization solutions followed by a Q&A session, and the DDF in Action event on 10 October, where participants will exchange insights and experiences on implementing the Unified Study Definitions Repository DDF solutions. These events will bring together sponsor companies, clinical solution providers, and industry stakeholders. Learn more about the events and the abstract submission process: https://lnkd.in/e5Na9eK9.
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Q2 CDISC Library Release Now Available! New CDISC Biomedical Concepts (BCs) and SDTM Dataset Specializations are now available in Package 8. NCIt and Codetable Mapping Files were used as source references for the new content. • BCs including Laboratory Tests (lipid measurements) and provisional BCs for Oncology Disease Response Criteria (LUGANO and RANO) • SDTM Dataset Specializations linked to the new BCs for LB and RS domains • Updates and enhancements to existing BCs and SDTM Dataset Specializations based on public review feedback CDISC Library now contains a total of 320 BCs and 312 SDTM Dataset Specializations, retrievable via the CDISC Library API: https://lnkd.in/eMu8XJ6z More information about CDISC Biomedical Concepts and SDTM Dataset Specializations can be found on the CDISC Biomedical Concepts website: https://lnkd.in/ehPEsyGN
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We invite you to participate in the Trial Master File Reference Model Annual Survey! This is the only non-commercial TMF survey conducted by and for the TMF stakeholder community. Please submit your responses by the survey deadline, July 26th. Take Survey: https://lnkd.in/g_EBxYuJ
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