Novel Clinical Trials

Adult & Child Center for Outcomes Research & Delivery Science (ACCORDS) supports innovation and interdisciplinary research across the CU Anschutz campus by providing support for the development of new projects, guidance on grant proposals, and consultative support for investigators. ACCORDS also offers support through their Methodological Cores and Educational, Training, Mentorship, Dissemination, and Outreach Programs.

Biostatistics, Epidemiology, and Research Design (BERD) provides statistical expertise and resources to investigators and trainees through statistical consultation and collaboration, educational seminars and courses, and access to advanced statistical tools.

Center for Innovative Design & Analysis (CIDA) serves as a study design and analytics resource for the CU Anschutz research community by having their diverse group of biostatisticians, data scientists, and health economists offer variety of support such as free one-hour consultations or short-term project guidance to building a year-long collaboration or developing new methodologies. 

Colorado Clinical and Translational Science Institute (CCTSI) supports translational research across campus by providing resources, integrating facilities and services, developing innovative tools, and catalyzing interdisciplinary research programs, which include: 

• Research Studio Program provides structured and collaborative round table discussions with research experts to help investigators at a variety of stages in the research process.
• Clinical and Translational Research Centers (CTRC) provides dedicated inpatient and outpatient research facilities to support investigator initiated, federally funded, and industry sponsored research using a fee-for-service model. 
• Translation Informatics offers fee-for-service support that help researchers to develop systems and better utilize informatic tools making it easy to store, retrieve, and use data, information, and knowledge. 

Colorado Multiple Institutional Review Board (COMRB) includes five institutional review boards (IRBs) that review all human subjects research conducted at CU Anschutz Medical campus and its affiliates (Children’s Hospital Colorado, Denver Health and Hospital Authority, University of Colorado Health, and VA Eastern Colorado Health Care System). COMIRB’s mission is to protect human research participants’ rights and welfare and to promote ethical research. 

Clinical Research Informatics and Innovation Unit (CRIIU)supports investigator initiated research or innovation by providing a data integration or modification with electronic health records or other clinical informatic tools using a fee-for-service model.

CReST provides experienced research professionals to assist with clinical research study start-up, implementation, and closeout including regulatory, coordination, and monitoring services. This helps alleviate the administrative burden associated with training and managing research staff and allows investigators to only pay for the amount of effort required. 

Clinical Research Support (CRS) Center is a team of highly motivated individuals with significant expertise in human subjects research rules, regulations, best practices, and operations that provide guidance and support to the CU Anschutz Medical research community, their research teams, and their internal and external partners. 

CU Innovations brings together key stakeholders including industry partners, entrepreneurs, and investors to collaborate with CU researchers to create biomedical technologies that improve health and quality of life translating scientific discoveries into real-world application.

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Data Safety Monitoring Board (DSMB) assistance provided to investigators to ensure subject safety and data integrity of IRB approved study protocols including identification of DSMB committee members, development of DSMB charter, administrative oversight, member compensation, and meeting setup and management. 

Health Data Compass is part of the Research Informatics Office (RIO) at the University of Colorado that integrates patient data from the electronic medical records at UCHealth and Children’s Hospital of Colorado, provider billing data from CU Medicine, -omics data from the Colorado Center of Personalized Medicine, and data from publicly available data sources. 

mHealth Impact Lab is an incubator for innovative, health technology and disease management initiatives based in the Colorado School of Public Health. The mHealth Impact Lab is comprised experts in the mobile and digital health technology field that provide guidance for product development and design, assistance with rigorous research and evaluation, and creation of curated evidence-based solutions that move the field forward. 

More information coming soon.

Protocol Review and Monitoring System (PRMS) is a committee of experts that reviews the scientific merit of oncology clinical trials and ensures the trials supports our institutional mission. PRMS has standardized the review and approval processes per NCI guidelines. 

REDCap is a secure, HIPAA-compliant web-based application that allows for remote data collection, data validation, audit tracking, and creation and management of online surveys. REDCap also has an eConsent functionality that allows to complete the informed consent processes remotely. 

Research Informatics Office (RIO) is the primary liaison between biomedical researchers and information technology professionals that facilitates socio-technical integration and shared governance to enhance team science and drive innovation using existing and creating new data assets, computational resources, and technologies and programs. 

Implements and oversees elements of decentralized clinical trials including remote visits and recruiting tools, eSigning, in-app patient communication, HIPAA-compliant video visits, and status alerts while overseeing and maintaining regulatory compliance via 21 CFR Part 11 compliant eConsent, eSource, and eRegulatory Management solutions.

Go to Advarra

 

Assists with recruitment needs by helping with the development of recruitment strategy based on study parameters and provide an expert team of online recruitment marketers while being mindful of audience specific content and adherence to local and federal regulations.

 

Go to Bump

 

An academic research organization that provides expertise and guidance in clinical trial design and operations, clinical monitoring and oversight, data management including access to part 11 compliant REDCap.

Go to CPC

 

Individuals and organizations that strive to improve the quality and efficiency of clinical trials that was co-founded by Duke University and the FDA by fostering an open forum of key stakeholders to exchange ideas and develop solutions to review change in clinical trials.

Go to CTTI

 

Enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research through education, training, and adoption of appropriate decentralized research methods.

Go to DTRA

 

Leverages technology and specialized services to engage participants within the community, and facilitate patient centric care including pre-screening, telemedicine visits, at-home treatment, and mobile research nurses and staff services.

Go to IQVIA

 

A clinical research company specializing in decentralized clinical trials by expanding researchers access to untapped patient populations through the Metasite while simultaneously allowing patients to participate from the comfort of their own home, at their local community clinic, or at a traditional site.

Go to Science37

 

A network that assists with protocol design, study feasibility, and site selection for hundreds of protocols across a variety of therapeutic areas.

Go to TriNetX

 

There are several wearable devices and mobile phone applications in use by CU investigators. See the list of wearable devices in development here, and contact us to add additional devices we may not be aware of.

Mayo Clinic Cures at Home program brings the clinical trial trams to participants by performing remote, direct-to-patient visits making participation in clinical research more convenient and increasing the accessibility to underrepresented populations. This program focuses on rare diseases and cancers.

Digital Health Solutions Program at Duke Clinical Research Institute partner with digital health innovators to bring clinical insights to groundbreaking applications that improve health outcomes.

Pragmatic Health Systems Research at Duke Clinical Research Institute leads and advances pragmatic health systems research that utilizes real-world data generated from routine patient care to generate evidence to improve healthcare.