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Coastal Carolina Health Care, P.A. Clinical Research has successfully participated in Phase II-Phase IV trials, observational/registry studies, and is experienced in all trial designs.  Study start-up can be completed within one month.  No local IRB-site utilizes central IRB, per sponsor.  IRB submissions can be completed prior to fully executed agreement.  We have consistently met/exceeded enrollment goals in many therapeutic areas.  Our team is comprised of 9 Investigators, 3 full-time Clinical Research Coordinators, 2 part-time Clinical Research Coordinators/RRT, and a part-time Medical Technologist for special procedures.  We have on-site radiography, fully certified laboratory, sputum processing/special procedure lab, PFT lab, infusion center, and biologic specimen storage freezer.  CCHC Imaging Center (full diagnostic capabilities), CCHC Sleep Lab, and CCHC Endoscopy Center are within walking distance of the site.  CCHC is experienced in advanced research with biologic and PK sampling. 

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2015
  • Phases of clinical studiesPhase II, Phase III, Phase IV
  • Types of studiesBiologics, Drugs, Vaccines
  • PopulationsAdult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of sitePart of a practice
  • # of employees involved in research16
  • # of investigators9
  • Number of studies last year4
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday
  • Extended office hoursYes
  • Overnight facilitiesYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS, DHL
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsRebecca Toler
  • Regulatory phone number252-639-5985
  • # of days to turn around regulatory documents1-2 weeks
  • Type of IRB used by this siteCentral
  • Appropriate storage facilities for productYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract3

Contact

  • Rebecca Toler

    Director of Research
    Coastal Carolina Health Care, P.A.
    New Bern, North Carolina