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Rheumatology

Rheumatology

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Investigators

Melvin A. Churchill, MD

PRINCIPAL INVESTIGATOR OF CLINICAL RESEARCH

View CV (PDF)

Lead Coordinator

Lisa M. Kastanek, RN, CCRC

MANAGING PARTNER, BUDGET/CONTRACT NEGOTIATION

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Therapeutic Areas of Research

Lead Coordinator

  • Total Patient Population 25,000 active patients
  • Osteoarthritis 5,000 active patients
  • Rheumatoid Arthritis 2,000 active patients
  • Osteoporosis 1,000 active patients
  • Systemic Lupus Erythematosus 700 active patients
  • Fibromyalgia 2,500 active patients
  • Psoriatic Arthritis 900 active patients
  • Ankylosing Spondylitis 125 active patients
  • Polymyalgia Rheumatica 200 active patients
  • Gout 100 active patients

Lead Coordinator

  • Three (3) Board Certified Rheumatologists
  • Two (2) Board Certified Advance Practice Registered Nurses
  • Six (6) Full-time Research Nurse Coordinators
  • Two (2) IATA Certified Phlebotomists/Coordinator Assistants
  • Regulatory Specialist
  • Data Entry Specialist
  • Two (2) Quality Assurance/Source Document Specialists
  • Administrative Assistant

Site Services

  • Experienced, GCP trained providers
  • Experienced, qualified, GCP trained and dedicated coordinators
  • Adherence to written SOP’s
  • Formal hiring and training program
  • Active quality control program
  • Two week completion of budget negotiations and regulatory submission
  • Rapid enrollment of qualified participants
  • Accurate and clean data collection
  • In compliance with HIPAA regulations with full confidentiality of sponsors and subjects

Site Amenities

Central IRB * High speed DSL and wireless connectivity at monitoring stations * Access to Copy/Scan/Fax available to monitors * Dedicated monitoring stations * Laptop for EMR access at each monitor station * Locked and secure medication storage * Locked and secure research offices * Locked and secure record archives * Computerized demographics * On-site laboratory (current CLIA and COLA certified) * Microscope * Variable speed centrifuge (quarterly calibration) * Refrigerator (2-8 degrees Celsius, annual calibration) * Freezer (-20 degrees Celsius, annual calibration) * Temperature monitoring wheel on refrigerator and freezer (annual calibration) * Ambient temperature monitoring (high/low thermometer) * Eclipse 850 ECG machine (calibrated yearly) * Two scales (annual calibration) * Digital radiography * SonoSite ultra sound machine * Lunar DXA Prodigy scanner * Professional Liability Insurance ($2,000,000 Cap in NE) * General Liability Insurance *

Working Relations With

Radiologists * MRI Facility * Mammography * Gastroenterology Lab * Ophthalmologist * Reference Laboratory * Walgreens * Many other options available for collaboration

SITE INFORMATIONAL LETTER (PDF)

RHEUMATOLOGY RESEARCH INVESTIGATORS:

  • Three (3) Board Certified Rheumatologists, active medical licenses, GCP certified, 90 cumulative years research experience on over 300 trials.
  • Two (2) Advanced Practice Registered Nurses-Nurse Practitioners, specialized in rheumatology, active nursing licenses, GCP certified, five (5) years cumulative years research experience as sub-investigators.
  • One (1) Certified Physician’s Assistant, specialized in rheumatology, active PA license, GCP certified with over five (5) years research experience as a sub-investigator.