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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
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Standards in sync: five principles to achieve semantic interoperability for TRUE research for healthcare - Frontiers

Standards in sync: five principles to achieve semantic interoperability for TRUE research for healthcare Frontiers

A Guide To Guidelines: How ICH And Others Help Us Conduct Better Trials - Clinical Leader

A Guide To Guidelines: How ICH And Others Help Us Conduct Better Trials Clinical Leader

Zifo’s AI Blueprints for Clinical Research Honored in CDISC Challenge - The AI Journal

Zifo’s AI Blueprints for Clinical Research Honored in CDISC Challenge The AI Journal

Oracle exec maps data integration strategy for modern clinical trials in 2025 and beyond - drugdiscoverytrends.com

Oracle exec maps data integration strategy for modern clinical trials in 2025 and beyond drugdiscoverytrends.com

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) - ScienceDirect.com

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) ScienceDirect.com

Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support | npj Digital Medicine - Nature

Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support | npj Digital Medicine Nature

Clinical Data Interchange Standards Consortium (CDISC) and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital (MRCT Center) Collaborate to Offer Plain Language Clinical Research Definitions as a New Standard - Business Wire

Clinical Data Interchange Standards Consortium (CDISC) and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital (MRCT Center) Collaborate to Offer Plain Language Clinical Research Definitions as a New Standard Business Wire

CDISC Appoints Dr. Erik Pulkstenis as Board Chair - citybiz

CDISC Appoints Dr. Erik Pulkstenis as Board Chair citybiz

Global Standardization of Clinical Research Data - Applied Clinical Trials

Global Standardization of Clinical Research Data Applied Clinical Trials

CDISC Selects Myota to Protect IP Against Ransomware Attacks - Silicon Canals

CDISC Selects Myota to Protect IP Against Ransomware Attacks Silicon Canals

Formedix and CDISC unite to provide free access to CDASH-Compliant eCRFs for accelerated clinical trial set-up - R&D World

Formedix and CDISC unite to provide free access to CDASH-Compliant eCRFs for accelerated clinical trial set-up R&D World

Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration - Frontiers

Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration Frontiers

TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability - Clinical Leader

TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability Clinical Leader

A pragmatic method for transforming clinical research data from the research electronic data capture “REDCap” to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDT - ScienceDirect.com

A pragmatic method for transforming clinical research data from the research electronic data capture “REDCap” to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDT ScienceDirect.com

CDISC and DiMe Partner to Advance DHT Data Standards to Improve Health Outcomes - Business Wire

CDISC and DiMe Partner to Advance DHT Data Standards to Improve Health Outcomes Business Wire

Harvesting metadata in clinical care: a crosswalk between FHIR, OMOP, CDISC and openEHR metadata - Nature

Harvesting metadata in clinical care: a crosswalk between FHIR, OMOP, CDISC and openEHR metadata Nature

ICH and CDISC Collaborate to Support the Maintenance and Governance Process for ICH M11 Controlled Terminology - Business Wire

ICH and CDISC Collaborate to Support the Maintenance and Governance Process for ICH M11 Controlled Terminology Business Wire

CDISC-compliant clinical trial imaging management system with automatic verification and data Transformation: Focusing on tumor response assessment data in clinical trials - ScienceDirect.com

CDISC-compliant clinical trial imaging management system with automatic verification and data Transformation: Focusing on tumor response assessment data in clinical trials ScienceDirect.com

Evaluating common data models for use with a longitudinal community registry - ScienceDirect.com

Evaluating common data models for use with a longitudinal community registry ScienceDirect.com

Accelerator Connects CDISC, HL7, and ICH M11 in a Project to Digitize Exchange of Clinical Research Protocols - Business Wire

Accelerator Connects CDISC, HL7, and ICH M11 in a Project to Digitize Exchange of Clinical Research Protocols Business Wire

Convert-Pheno: A software toolkit for the interconversion of standard data models for phenotypic data - ScienceDirect.com

Convert-Pheno: A software toolkit for the interconversion of standard data models for phenotypic data ScienceDirect.com

A novel semantic representation for eligibility criteria in clinical trials - ScienceDirect.com

A novel semantic representation for eligibility criteria in clinical trials ScienceDirect.com

Interactive medical and safety monitoring in clinical trials with clinDataReview: a validated and open-source reporting tool - Frontiers

Interactive medical and safety monitoring in clinical trials with clinDataReview: a validated and open-source reporting tool Frontiers

From data silos to insights: the PRINCE multi-agent knowledge engine for preclinical drug development - Frontiers

From data silos to insights: the PRINCE multi-agent knowledge engine for preclinical drug development Frontiers

A federated semantic metadata registry framework for enabling interoperability across clinical research and care domains - ScienceDirect.com

A federated semantic metadata registry framework for enabling interoperability across clinical research and care domains ScienceDirect.com

Procurement of shared data instruments for Research Electronic Data Capture (REDCap) - ScienceDirect.com

Procurement of shared data instruments for Research Electronic Data Capture (REDCap) ScienceDirect.com

The Ontology of Clinical Research (OCRe): An informatics foundation for the science of clinical research - ScienceDirect.com

The Ontology of Clinical Research (OCRe): An informatics foundation for the science of clinical research ScienceDirect.com

PlatformTM, a standards-based data custodianship platform for translational medicine research | Scientific Data - Nature

PlatformTM, a standards-based data custodianship platform for translational medicine research | Scientific Data Nature

Automated approach for quality assessment of RDF resources - BMC Medical Informatics and Decision Making

Automated approach for quality assessment of RDF resources BMC Medical Informatics and Decision Making

Effective data management: lessons to learn from Big Pharma - European Pharmaceutical Review

Effective data management: lessons to learn from Big Pharma European Pharmaceutical Review

Securely sharing DSMB reports to speed decision making from multiple, concurrent, independent studies of similar treatments in COVID-19 - Cambridge University Press & Assessment

Securely sharing DSMB reports to speed decision making from multiple, concurrent, independent studies of similar treatments in COVID-19 Cambridge University Press & Assessment

FDA sets CDISC implementation timeline - Regulatory Affairs Professionals Society | RAPS

FDA sets CDISC implementation timeline Regulatory Affairs Professionals Society | RAPS

Recommendations to Optimize the Use of Volumetric MRI in Huntington's Disease Clinical Trials - Frontiers

Recommendations to Optimize the Use of Volumetric MRI in Huntington's Disease Clinical Trials Frontiers

Cross-Standard Health Data Harmonization using Semantics of Data Elements - Nature

Cross-Standard Health Data Harmonization using Semantics of Data Elements Nature

An informatics framework for the standardized collection and analysis of medication data in networked research - ScienceDirect.com

An informatics framework for the standardized collection and analysis of medication data in networked research ScienceDirect.com

Certara Announces the Availability of PK Submit, its Pharmacokinetic CDISC Technology Solution - Lab Manager

Certara Announces the Availability of PK Submit, its Pharmacokinetic CDISC Technology Solution Lab Manager

CDER Plots Pilot Project to Test CDISC Standard - Regulatory Affairs Professionals Society | RAPS

CDER Plots Pilot Project to Test CDISC Standard Regulatory Affairs Professionals Society | RAPS

ImmPort, toward repurposing of open access immunological assay data for translational and clinical research - Nature

ImmPort, toward repurposing of open access immunological assay data for translational and clinical research Nature

A patient-level pooled analysis of treatment-shortening regimens for drug-susceptible pulmonary tuberculosis - Nature

A patient-level pooled analysis of treatment-shortening regimens for drug-susceptible pulmonary tuberculosis Nature

Development of electronic medical records for clinical and research purposes: the breast cancer module using an implementation framework in a middle income country- Malaysia - BMC Bioinformatics

Development of electronic medical records for clinical and research purposes: the breast cancer module using an implementation framework in a middle income country- Malaysia BMC Bioinformatics

Clinical trial data sharing: here’s the challenge - BMJ Open

Clinical trial data sharing: here’s the challenge BMJ Open

Sharing and reuse of individual participant data from clinical trials: principles and recommendations - BMJ Open

Sharing and reuse of individual participant data from clinical trials: principles and recommendations BMJ Open

Mode of Death in Heart Failure With Preserved Ejection Fraction - ScienceDirect.com

Mode of Death in Heart Failure With Preserved Ejection Fraction ScienceDirect.com

Concept and implementation of a study dashboard module for a continuous monitoring of trial recruitment and documentation - ScienceDirect.com

Concept and implementation of a study dashboard module for a continuous monitoring of trial recruitment and documentation ScienceDirect.com

Clinical Data Standards in the era of AI, ML and digital transformation - Express Pharma

Clinical Data Standards in the era of AI, ML and digital transformation Express Pharma

The Planner: 11 upcoming galas - Austin American-Statesman

The Planner: 11 upcoming galas Austin American-Statesman

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