Driving innovative research to transform novel ideas to better human life
The research community across CU Anschutz Medical Campus performs hundreds of clinical trials in a broad range of research fields – all crucial to answering difficult scientific and health questions, which can lead to the development of new and enhanced drugs and treatments.
The Novel Clinical Trials Program strives to provide the necessary expertise and resources to expand the research infrastructure to support new and innovative study designs. The program will primarily focus on Decentralized Clinical Trials (DCT).
Visualize the Spectrum of Novel Clinical Trials
Our expertise is the development, implementation, and oversight of decentralized, virtual, hybrid, and pragmatic clinical trials; here's how it works:
NOVEL CLINICAL TRIALS TOOLBOX
Campus Resources
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.
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 Informaticsoffers 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 (COMIRB) 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 Innovationsbrings 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.
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 Compassis 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 Labis 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.
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.
Note: This list of campus resources is in development, and therefore, not exhaustive. If you are aware of another campus resource that is not on this list, please email us.
External Resources
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
eConsent Platform Vendors
There are a variety of eConsent vendors available to CU Anschutz research teams. The Office of the Vice Chancellor for Research (OVCR) has reviewed several of these platforms. Below is a summary of the eConsent platforms that the OVCR has met with. If you would like more detailed information, a demo of the platform, and pricing information, please reach out to the company email below.
Allows research teams to easily configure consent documents and signatures required for the individual study supporting both in-person and fully remote informed consent visits. The Advarra eConsent also supports a variety of consent workflows including when a legally authorized representative needs to sign the consent document or a witness is required.
Other key features: fully integrated with Advarra’s other products such as OnCore and CIRBI; has strict version control and complete audit trail; all data is accessible and backed up on secure web portal which simplifies remote monitoring.
More information about Advarra, their products and services can be found on their website at https://www.advarra.com/. For more detailed information about security and privacy or to request pricing estimates for your specific study, please reach out to https://www.advarra.com/contact-us/.
Offers a unified, modular platform that includes three main products: Connect, Edge, and Conduct. The modular platform offers a variety of services including eConsent, Electronic Data Capture, randomization, medical coding, Clinical Management Trial System, eTMF, and ePRO services. The platform also supports home health services and integrates with a variety of wearables and connected devices (both iOS and Android).
The eConsent platform allows for fully remote consent and assent collection in complete offline mode that is CFR part 11, HIPAA, and GDPR compliant. The site and sponsor can export data in various file formats.
Other key features: research teams can use video consent for informed consent process or witness consenting; the platform supports 25+ languages; platform supports rich analytics with configurable dashboards, reports, and workflows; and web-based training for sites and sponsors.
More information about CliniOps, their products and services can be found on their website at https://www.cliniops.com/. For more detailed information about security and privacy or to request pricing estimates for your specific study, please reach out to info@cliniops.com.
ClinOne Software offers a full suite that can be utilized together or as individual applications. This includes a document management system, medication adherence monitoring, patient ride portal, communication portal, and eConsent system.
The eConsent module allows research teams to complete the consent process either in-person or remotely, including assent or consent from legally authorized representatives. The module provides a controlled workflow to ensure the consent document is signed before any data collection.
Other key features: eConsent application is translated into Spanish, French, German, Italian, Dutch, and Japanese; platform allows virtual consent calls; knowledge check questions can be integrated into the informed consent document; and support variety of different signer roles (e.g., PI, research staff, caregiver, LAR, etc.).
More information about ClinOne, their products and services can be found on their website at https://www.clinone.com/inform/. For more detailed information about security and privacy or to request pricing estimates for your specific study, please reach out to support@clinone.com.
Provides a modular eClinical platform that includes informed consent, pre-screening, clinical assessments, patient-reported outcomes, remote tele or video visits, and tracking medication adherence.
The eConsent as a Service (eCaaS) allows researchers to send eConsent documents to participants via a platform hosted on a secure AWS cloud that is CFR Part 11 and HIPAA Compliant. Allows for the research team to easily switch between remote or in-person informed consent visits as the eConsent document is a PDF enabled by an eSignature.
Other key features: fully remote electronic informed consent via live interactive video call that are recoded securely within the platform; support for central and site-specific IRBs to review eConsent experience.
More information about Jeeva Clinical Trials, their products and services can be found on their website at https://jeevatrials.com/. For more detailed information about security and privacy or to request pricing estimates for your specific study, please reach out to info@jeevatrials.com.
Provides infrastructure for digital health research and decentralized clinical trials including three services: Research Cloud, Participant Experience Manager, and Data Explorer.
Participant Experience Manager is the portal where the eConsent platform is maintained. The eConsent platform allows integration of multimedia and communication with the participants directly through the platform via email or SMS. Participants do not need to create an account or have broadband internet access, and they are able to withdraw their consent at any point.
Other key features include: The platform is CFR part 11 and HIPAA compliant; integrates with several clinical trial management systems, REDCap, and electronic medical or health record systems (e.g., EPIC); has the ability to support survey and data collection; automated email and SMS notifications for reminders; has reporting within the dashboard; can easily export data in different file formats; has no restriction on the amount of data collected or stored within the system; and participant facing webpage and mobile application will be CU-branded.
More information about Vibrent and their products and services can be found on their website at https://www.vibrenthealth.com/. For more detailed information about security and privacy or to request pricing estimates for your specific study, please reach out to info@vibrenthealth.com.
Wearable Devices
There are several wearable devices and mobile phone applications in use by CU investigators.See thelist of wearable devices in development here, and contact us to add additional devices we may not be aware of.
Universities and Academic Medical Centers
A research and policy center that convenes multidisciplinary teams to identify expert stakeholders from industry, academia, advocacy groups, nonprofit organizations, and regulatory agencies to address critical issues in the conduct and oversight of clinical trials.
Visit their site for a variety of resources including presentations, workshops and webinar proceedings, articles and publications, reports, guidance documents, templates, and training materials.
Digital Health Solutions Program at Duke Clinical Research Institutepartner with digital health innovators to bring clinical insights to groundbreaking applications that improve health outcomes.
