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PRC ADDRESS:

3901 Pine Lake Road, Suite #120

Lincoln, NE 68516

Phone:  +01 402-420-3442

FAX:  +01 402-328-0971

PRC does not have satellite sites and conducts all trials in one private practice office.

PRC DEDICATED RESEARCH STAFF:

  • Full time licensed coordinators, GCP certified, 30 cumulative years of research experience.

  • Full time phlebotomists/coordinator assistants that are IATA and GCP certified.

  • Full time regulatory specialist

  • Full time data entry specialist

  • Full time source document specialists

  • Full time administrative assistant and scheduler

  • Full time research accountant

  • We are experienced with trials requiring un-blinded duties and independent assessments.
  • We are experienced with trials requiring independent staff management of un-blinded lab results.

CTA/Budget:

  • The CTA/Budget is negotiated within 2 weeks.
  • CTA/budget negotiations can be done congruently with all other study start up activities.

IRB/IBC

  • Exclusively use a central IRB.
  • Regulatory is completed within one week.
  • We have no additional boards or committees requiring review and approval.

REGULATORY:

  • Regulatory is completed within one week.

FACILITY:

Monitor Amenities:

  • Two 45 square feet dedicated monitoring areas.
  • High speed public and private Wi-Fi available.
  • High speed Ethernet wired internet connection available.
  • Laptop for electronic medical record (EMR) access.
  • Copy and fax machine close to work station.
  • Hotels, dining and shopping within one mile.
  • Lincoln Municipal Airport 13 miles and 22 minutes from our site.
  • Eppley Airfield, Omaha, NE is 65 miles and 1.25 hours from our site.

Storage/Supplies:

  • Adequate space to accommodate study storage during the trial.
  • Send all study supplies, except IP, to the PRC Lead Coordinator at 3901 Pine Lake Road, Suite 120, Lincoln, NE 68516.

Investigational Product (IP):

  • We provide locked ambient, locked refrigerated and locked -20 Freezer space for IP.
  • Refrigerator and freezer are temperature monitored and recorded every business day with both a temperature monitoring wheel and a min/max thermometer.
  • Ambient storage is temperature monitored and recorded every business day with a min/max thermometer.
  • Temperature monitoring is calibrated yearly.
  • IP storage is in a secure location away from patient traffic.
  • Only research staff has access to the keys to the locked IP storage cabinets; ambient, refrigerated and frozen at -20.
  • We accommodate trials needing un-blinded IP staff.
  • All IP will be sent directly to the site in which the IP will be dispensed to the subjects.

Equipment:

  • ECG-twelve lead (calibrated yearly)
  • Patient Scale-two (2) patient scales (calibrated yearly)
  • Manual Sphygmomanometer -three (3) (calibrated yearly)
  • Digital Oral Thermometer -one (1) (calibrated yearly)
  • Stadiometer-two (2) (calibrated yearly)
  • Variable Speed Centrifuges-three (3) (calibrated twice yearly)
  • Refrigerator-2-8 degree Celsius (calibrated yearly)
  • Freezer-(-20) degree Celsius (calibrated yearly)
  • Temperature Monitoring Wheel-two (2), one for 2-8 degree Celsius refrigerator and one for -20 degree Celsius freezer (calibrated yearly)
  • Minimum/Maximum Thermometers-three (3) replaced before calibration expires. One each for 2-8 degree Celsius refrigerator, for -20 degree Celsius freezer and for ambient storage.

Radiology:

  • Digital radiographic capability.
  • Close and reliable access to Radiologists with a complete spectrum of imaging services.

DEXA:

  • Lunar DXA Prodigy scanner
  • Experience sending DEXA scans to central reading facilities.

IV Infusions:

  • Blinded and un-blinded access to infusion services.
  • Infusion pumps calibrated yearly.

Emergency Response:

  • Emergency crash cart.
  • An approximate emergency response time from the emergency medical system (EMS) of seven (7) minutes.
  • Nearest hospital is Bryan LGH Medical Center, East at 1600 S. 48th Street, Lincoln, NE.
  • The hospital is five miles away and would take approximately13 minutes to travel in a non-emergent situation.

Laboratory

  • Local full complexity laboratory with CLIA and COLA accreditation.
  • Reference laboratory available as necessary.

Dry Ice

  • Available daily

Hours:

  • Monday through Friday, 7:30 AM- 4:30 PM CST.
  • No holiday hours.

RHEUMATOLOGY RESEARCH INVESTIGATORS:

  • Two (2) Board Certified Rheumatologists, active medical licenses, GCP certified, 70 cumulative years research experience on over 300 trials.
  • Four (4) Advanced Practice Providers, specialized in rheumatology, active licenses, GCP certified, twenty (20) cumulative years research experience as sub-investigators.

CONTACT INFORMATION :

PRC Primary Contact:

Lisa Kastanek, RN, CCRC, Managing Partner

Email:  Lisa.Kastanek@prcmedresearch.com

Phone:  +01 402-420-3433

FAX:  +01 402-328-0971

 

PRC Directors of Clinical Research:  Melvin A. Churchill, MD and Rick C. Chatwell, MD

Email:  Melvin.Churchill@prcmedresearch.com; Rick.Chatwell@prcmedresearch.com

Phone:  +01 402-420-1212 extension 4

FAX:  +01 402-328-0971