The Essentia Institute of Rural Health has a dedicated department of research registered nurses (RNs), research coordinators and research assistants for clinical trials. All staff has experience, knowledge and training to conduct clinical trials according to U.S. Food and Drug Administration (FDA) regulations and good clinical practice.
Research nurses who qualify are certified by the Association of Clinical Research Professionals. Research assistants who qualify are certified by the Society of Clinical Research Professionals.
The institute participates in Phase II-IV industry research and National Cancer Institute trials. Studies include industry and consortium rheumatology research, cardiology and multispecialty studies, both acute and outpatient.
We've had a local Institutional Review Board (IRB) for more than 30 years – since research was launched in 1978 by the Duluth Clinic, which is now part of Essentia Health.
IRB#: IRB00001080 Verify the Essentia Health IRB with the Office for Human Research Protections
Our clinical research facilities are based on the former SMDC Health System campus in downtown Duluth. Most industry-sponsored research is administered from an office located in a building adjacent to Essentia Health-St. Mary's Medical Center. Our laboratory, Investigational Drug Pharmacy, medical offices and procedure areas are accessible via skywalk.
Our certified laboratory has access to dry ice, PK capabilities and courier services. A -20° C and -70° C freezer with temperature-recording devices is available as well as ambient and refrigerated centrifuges and an alarm system. We have dedicated phlebotomy areas, both outpatient and hospital-based service, and a designated processing area. We are CLIA/CAP certified, and all staff is certified FFA/IATA.
Investigational product is stored in a limited access, secured investigational pharmacy. Refrigerator and freezer temperature are continuously electronically monitored with alarm; the room temperature is manually monitored. The pharmacy is staffed Monday through Friday by pharmacy staff and hospital-based study medication is available 24/7. The surgery pharmacy is staffed Monday through Friday by pharmacy staff.
Our Infusion Clinic has accessible emergency equipment, BCLS/ACLS-certified staff CRF storage and experience with electronic data capture.
Our monitoring facilities have high-speed Internet access as well as copy machines, FAX machines and phones. We have designated monitoring work space.
Electronic medical record (EpicCare) is available on computer and in paper form. It is FDA 21 CFR part 11 compliant
Regulatory documents and contract budget negotiation are processed by the Essentia Institute of Rural Health Administrative Office.
Essentia Health has healthcare facilities in 4 states: Minnesota, Wisconsin, North Dakota and Idaho. Essentia Health is a not-for-profit, 501(c)(3), integrated healthcare system with headquarters in Duluth, Minn. Currently Essentia has 17 hospitals, 62 clinics, 750 physicians, 1,000 credentialed practitioners, and 13,000 employees that care for approximately 900,000 patients. Our service area is mainly rural areas with small towns and cities. EpicCare electronic health record system is fully implemented in many facilities, and distributed care centers across these rural areas.
On January 1, 2010, the Essentia Institute of Rural Health became a non-profit, 501(c)(3), within Essentia Health.
During a recent fiscal year, our research enterprise engaged over 1,800 human subjects in clinical trials or other studies, had 395 active research projects or clinic trials and received over $3.3 million in research grants and contracts with an additional $1.2 million of internal dollars spent on research.
Our sponsored, clinical research began in 1978 when the former Duluth Clinic and SMDC Health System (now part of Essentia Health) joined cancer clinical trials through the North Central Cancer Treatment Group funded by National Cancer Institute. An IRB and other research infrastructure were created the same year. In 1990 SMDC established a formal research division to perform clinical, translational, and health services research.
In June 2009, we implemented an operational, web-based Internet Medical Research Information System (IRIS). The enterprise-wide application integrates scientific review, human subject protection, contract/grants management study and study management into one application. It is HIPAA compliant and provides efficiency for data input and maximum data availability for central oversight. This application can be easily extended for research enterprise management in all Essentia affiliates.
Essentia Health Information Services has three main work groups located in Duluth, Minn. (formerly SMDC Health System); Fargo, N.D., (formerly Innovis Health); and Brainerd, Minn. (formerly Brainerd Lakes Health). EHIS maintains four data centers located in Fargo, Brainerd, and two large facilities in Duluth that occupying more than 5,300 square feet of raised floor space. All four data centers are protected with uninterruptible power supplies (UPS), backup generators, fire suppression and N+1 cooling. The Duluth facilities form an active-active tandem that hosts redundant technology for the majority of applications and services. Wide area network and Internet connections are redundant in these two facilities. Also, Duluth campus buildings are served by redundant geographically diverse fiber paths and highly resilient chassis switches. Regional facilities are connected via high-speed private Ethernet, cable broadband and T-1 services.
EHIS delivers and supports over 500 applications; among these are electronic health record systems (Epic, Cerner and Meditech), Lawson Enterprise Resource Planning (ERP) as well as numerous ancillary and business support applications. The EHIS group also supports many custom built client-server and web-based applications. The web development group recently deployed a physician and executive portal spanning the entire organization. The portal provides a means of communication amongst physicians, credentialed practitioners and partners across Essentia Health. The Duluth IS group also maintains a complex HL7 data interface environment linking a large number of clinical and business applications on a variety of operating system and database platforms.
