Partnerships

CDISC’s impact as an organization is multiplied by our collaborations with global partners. Through partnership, we can continue to advance interoperable standards across a wide range of therapeutic areas so greater clarity is achieved, more powerful research is conducted, and more meaningful connections are discovered. As our dedication and collaboration continue to grow, so will our collective impact on global health. Key partners and collaborative efforts include:


ACRO

ACRO and its members advocate as the collective voice of the innovative clinical research industry to regulators and policymakers, educating stakeholders and shaping policies that foster efficient, effective and safe conduct of clinical research. ACRO and CDISC share many members; these members and the ACRO staff serve on various CDISC steering committees, providing guidance for a variety of projects to further the CDISC mission.


ARO council

ARO Council's mission is to build a network of academia nationwide, promoting cooperation, and contributing to the improvement of public health through safer and more effective medical treatment. ARO Council was initiated in Japan by Prof. Masanori Fukushima of the Translational Research Informatics Center (TRI), Foundation for Biomedical Research and Innovation. The ARO Council has now expanded beyond Japan to Taiwan, Singapore and South Korea.


c-path

The Critical Path Institute (C-Path) is a nonprofit, public-private partnership with the US Food and Drug Administration (FDA) created under the auspices of the FDA's Critical Path Initiative program in 2005. C-Path's mission is a catalyst in the development of new approaches to advance medical innovation and regulatory science.

An international leader in forming collaborations, C-Path has established numerous global, public-private partnerships from government and regulatory agencies, academia, patient advocacy organizations, and dozens of pharmaceutical companies. These partnerships work on "drug development tools" (DDTs) and novel methodologies such as biomarkers, clinical outcome assessment instruments, and pharmacodynamic models that are submitted for official review and endorsement by the regulatory agencies.

CDISC and C-Path have a long and successful history of collaborating via the Coalition for Accelerating Standards and Therapies (CFAST) initiative, which has resulted in the development of over 30 Therapeutic Area User Guides.


embl-ebi

EMBL-EBI makes the world’s public biological data freely available to the scientific community via a range of services and tools, performs basic research and provides professional training in bioinformatics. CDISC collaborates with EMBL-EBI in a number of ways and has held workshops and symposia in collaboration with EMBL-EBI.

 


himss

Healthcare Information and Management Systems Society, Inc. (HIMSS) is a global advisor, thought leader and member association committed to transforming the health ecosystem. CDISC and HIMSS have a long-standing relationship and, in collaboration with Integrating the Healthcare Enterprise (IHE) USA, work together to foster the adoption of standards to enable the interoperability of health IT systems. Integrating the Healthcare Enterprise USA (IHE USA) improves the quality, value, and safety of healthcare by enabling rapid, scalable, and secure access to health information at the point of care. 

CDISC partners with IHE on standards development through the Quality, Research and Public Health domain and demonstrates interoperability capabilities at the HIMSS Interoperability Showcases™. HIMSS and CDISC participate in activities focused on improving workflow, so clinicians can conduct prospective medical research using EHRs, and fully realize the important link between clinical research and patient care, paving the way for a learning health system.

CDISC has collaborated with IHE to develop ­­­nine IHE integration profiles for clinical research. Organizations that use these standards can eliminate the need for cumbersome, research-related verification steps and redundant data entry, improving data quality and trustworthiness.

HIMSS encourages using CDISC standards and EHR data for clinical research; CDISC supports HIMSS strategic initiatives for advancing interoperability standards to achieve health IT integration. The two organizations develop and disseminate information and standards documentation on the role of IHE profiles and CDISC standards in advancing clinical research.


imi

The Innovative Medicines Initiative (IMI) works to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need.  IMI is the world's biggest public-private partnership in the life sciences. It is a partnership between the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations).

The IMI and CDISC are working together to enhance the use of information gathered for the purpose of developing safer, more effective innovative medicines for patients.

IMI-funded organizations can receive a 20% discount off CDISC annual membership fees at either the Gold or Platinum Levels.


jic

The Joint Initiative Council for Global Health Informatics Standardization to further the important role of health informatics standards to:

  • Enable interoperability of information and processes across health domains
  • Support the timely, efficient delivery of safe, coordinated, accountable, high-quality health services to individuals, communities and populations
  • Facilitate effective global markets for health information systems

The Council, operating as a council of equals and as a liaison group under ISO/TC 215, consists of the respective leaders and appointed liaison members of the participating SDOs to a maximum of three members per SDO. Members include: CDISC, CEN Health Informatics TC251, DICOM, GS1, HL7, IHE, ISO TC215, and SNOMED.


mapi

Mapi Research Trust is dedicated to improving patients’ quality of life by facilitating access to Patient-Centered Outcome (PCO) information. Mapi Research Trust promotes scientific approaches in the PCO field and encourages exchanges between academics, pharmaceutical companies, and international organisations around the world in the service of incorporating the patient’s voice into every step of the development process of new treatments.

Mapi Research Trust is the #1 provider of Patient-Centered Outcomes Research information worldwide:

  • More than 4,000 Clinical Outcomes Assessments (COA)
  • More than 40,000 COA translations
  • A research library with more than 29,000 COAs
  • Directly distributes over 600 questionnaires on behalf of their authors

CDISC and Mapi Research Trust work together to ensure copyrighted instruments are available to CDISC to create QRS supplements by leveraging PROQOLID™, Mapi Research Trust’s comprehensive online database designed to assist academic researchers, physicians, students, pharmaceutical companies, health authorities, and international organizations in the search and evaluation of COAs.


nci evs

NCI EVS is a founding partner in the development of Controlled Terminology content, tools, and services to accurately code, analyze and share cancer and biomedical research, clinical and public health information. CDISC and NCI-EVS work together to create Controlled Terminology that is linked to other common research semantics through EVS tools for CDISC Foundational Standards and Therapeutic Area User Guides. NCI is an active participant throughout CDISC’s global community, providing subject matter expertise on many steering committees to implement strategic goals.


phuse

PHUSE is an independent, not-for-profit organisation run by a worldwide team of volunteers whose mission is sharing ideas, tools and standards around data, statistical and reporting technologies to advance the future of life sciences.

CDISC and PHUSE partner to further the mission of each organization, with CDISC focusing on developing global, platform-independent data standards, and PHUSE focusing on implementing CDISC standards. The two organizations combine efforts on key initiatives around beginning-to-end standards and semantics, strengthening an interdependent process. One initiative is the CDISC  Primer, which comprises a series of short, animated videos as well as helpful links to introduce newcomers to the suite of CDISC Standards.

PHUSE is CDISC’s preferred partner for implementation questions and issues. CDISC thanks the PHUSE volunteers for their service to the clinical data standards community.  Please visit the PHUSE website to learn more about ongoing collaborations as well as about PHUSE working groups.


scdm

SCDM’s mission is to connect and inspire professionals managing global health data with global education, certification and advocacy.

CDISC and SCDM share many members and volunteers and have aligned missions of improving global clinical data management and support each other through events and initiatives that further this mission.


transcelerate biopharma inc.

TransCelerate BioPharma’s mission is to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines.

CDISC and Transcelerate share many members and volunteers. CDISC is active in TransCelerate work groups including data standards, eSource, and the Protocol team and many TransCelerate volunteers have provided their subject matter expertise to the development of Foundational and TA standards. CDISC is grateful for the resources and financial support TransCelerate has invested in CDISC to further the aligned strategic goals of each organization.