Information for Research Sponsors

EIRH Research Facts

  • The Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) certifies Essentia research nurses who meet the professional certification criteria.
  • SOCRA certifies qualified Essentia research assistants
  • The EIRH participates in Phase Ib-IV industry acute and outpatient device and investigational medication trials, device registries, national consortium research, and studies sponsored by the National Cancer Institute
  • The Essentia Institutional Review Board (IRB) reviews all research at Essentia to ensure the protection of human subjects.
  • The EIRH Scientific Review Board reviews all research at Essentia for scientific merit.

The Essentia Institute of Rural Health (EIRH) is the research and education center of Essentia Health. Learn more about EIRH.

Experienced Research Staff

EIRH staff members have the experience, knowledge, and education to conduct clinical trials according to U.S. Food and Drug Administration (FDA) regulations, Office of Human Research Protection (OHRP) guidelines, and research clinical practice. Our department includes:

  • Clinical research registered nurses
  • Clinical trials recruiters
  • Clinical research specialists
  • Clinical research coordinators
  • Clinical research assistants.

Clinical Research Facilities

Essentia Health conducts clinical research in Duluth, Minnesota; Brainerd, Minnesota; Fargo, North Dakota; and surrounding areas.

Most industry-sponsored research is administered at Essentia Health-St. Mary's Medical Center in Duluth. Laboratory, investigational drug pharmacy, cardiac and cardiac device special procedure areas, and medical offices are accessible via skywalk.

Laboratory

The Essentia Health laboratory is accredited by the College of American Pathologists (CAP) and holds a Clinical Laboratory Improvement Amendments (CLIA) certificate. The laboratory staff is certified FFA/IATA.

The laboratory includes or has access to:

  • Alarm system
  • Ambient and refrigerated centrifuges
  • Courier services
  • Dedicated areas for phlebotomy and processing
  • Dry ice
  • PK capabilities
  • Ultra-low temperature laboratory freezer, which can protect specimens at minus 20 degrees Celsius and minus 70 degrees Celsius freezer

Pharmacy

Essentia’s secure, limited-access, investigational pharmacy stores investigational product. An electronic alarm continuously monitors refrigerator and freezer temperatures. The investigational pharmacy is staffed Monday through Friday, and hospital-based study medication is available 24/7. The surgery pharmacy also is staffed Monday through Friday.

Ambulatory Infusion Clinic

The Essentia Health Ambulatory Infusion Clinic has accessible emergency equipment and BCLS/ACLS-certified staff. The clinical studies departments provide CRF storage, and staff experienced with a wide variety of electronic data capture systems.

Data Monitoring Facilities & Practices

Monitoring facilities have broadband high-speed Internet access as well as copy machines, FAX machines, and phones. We have designated monitoring workspace. EIRH staff maintains long-term CRF storage at an offsite storage facility.

The FDA 21 CFR part 11 compliant electronic medical record system (EpicCare) is available on computer and in paper form. Study Monitors are required to complete Essentia compliance training and have password-protected access to view electronic medical records.

Dedicated data entry staff have experience with Phase forward-InForm, RAVE, and Oracle electronic data capture systems, and a wide range of other data capture systems.

Clinical research staff keeps and maintains completed source documentation, clinical research files, and regulatory binders in a locked clinical research trials office.

The EIRH administrative office manages regulatory documents and contract and budget negotiations.

OHRP Verification

IRB#: IRB00001080

Verify the Essentia IRB

Data Centers

Our data centers, which are located in Duluth, Brainerd, and Fargo, include:

  • Uninterruptible power supplies (UPS)
  • Backup generators
  • Fire suppression and N+1 cooling protection

Our two 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 facilities. Redundant geographically diverse fiber paths and highly resilient chassis switches serve Duluth campus buildings.

High-speed private Ethernet, cable broadband, and T-1 services connect regional facilities.

Information Services Support

The Essentia Health Information Services (EHIS) 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 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.

Contact Us

Get more information about the Essentia Institute of Rural Health and its programs. Call 218-786-3940 or 1-877-710-1094.

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