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The MSHA Corporate Department of Research serves as the central office for multi-specialty research oversight in the Mountain States Health Alliance (MSHA) healthcare system that is composed of 13 hospitals and provides an integrated comprehensive continuum of care to people in 29 counties in Tennessee, Virginia, Kentucky, and North Carolina. The research department had participated in several large-scale, industry-sponsored multi-center trials with subject retention at a nearly unheard of 100% rate. Department received an excellent evaluation by sponsor’s auditors.

The Research Department is dedicated to:
•Providing consistent oversight and management of clinical research performed at MSHA
•Ensuring regulatory compliance and fiscal responsibility
•Creating a research culture across MSHA facilities
 

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2006
  • Phases of clinical studiesPhase II, Phase III, Phase IV
  • Types of studiesDrugs, Medical Devices, Vaccines
  • PopulationsInfant 0-1yr, Child 2-10 yrs, Adolescent 11-17 yrs, Adult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of siteHospital
  • # of employees involved in research13
  • # of investigatorsto be recognized based on the design of the study
  • Number of studies last year10
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsNonna Stepanov
  • Regulatory phone number423-431-5654
  • # of days to turn around regulatory documents5 business days
  • Type of IRB used by this siteCentral, Local
  • How often does your local IRB meet?Monthly
  • Appropriate storage facilities for productYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contractup to 4 weeks

Contact

  • Nonna Stepanov
    Nonna Stepanov

    DIrector, Research Program
    MSHA, Department of Research
    United States