Clinical Physiology Associates Facts:

  • Founded in 1978.
  • Its dedicated outpatient study center is a modern 3,500 square foot facility with a site laboratory (CLIA Certificate of Waiver).
  • Passed FDA inspections in March 1996 and November-December 2006 for studies with high patient enrollment. A form 483 was not issued following either inspection.
  • Maintains a computerized patient tracking system.
  • Is fluent with RDE (remote data entry).
  • Patient recruitment is typically achieved by the following means:
  • Physician investigator's private practice patients
  • Repeat study patients
  • Advertising: television, newspaper, and radio
  • Study Center newsletter



Facility:

Dedicated outpatient study center is a modern 3,500 square foot facility with a certified on-site laboratory.


  • Examination rooms (5)
  • Laboratory work areas (2)
  • Conference rooms [monitor work areas with telephone & DSL internet] (3)
  • Double locked limited access drug storage room (temperature monitored 24/7)
  • Shelves
  • Countertops
  • Refrigerators/freezers (Temperature monitored and recorded 24/7)
  • Locked steel controlled substance cabinet
  • Physician dictation area with X-ray view box
  • Computer room with on line data entry
  • Coordinator's offices (5)
  • Administrative offices (4)
  • Spacious waiting room
  • Rest rooms (3)

  • Emergency Equipment
  • Oxygen (two cylinders)
  • Ambu bag
  • Selected Medications


Certifications:

- Federalwide Assurance Number: PWA00000666
- CLIA Laboratory license (identification number 10D0981945)



Staff:

COORDINATORS:

Full time study coordinators range in experience from 1 year to 7 years. All are either certified clinical research coordinators (CCRC) or pursuing this goal.

All coordinators are currently certified in:

  • Shipping Infectious & Biological Substances as per 49 CFR section 172,702 & IATA regulations.

  • Good Clinical Practices: Protection of Human Research Subjects (NIH Office of Human Subjects Research)

  • HIPAA Guidelines for Clinical Researchers [Lee Health System Institutional Review Committee]

  • Cardiopulmonary Resuscitation (Basic Life Support)


INVESTIGATORS:

Investigators are board certified in the following areas (numbers within parentheses refer to the number of persons involved)

- GI endoscopists (3)
- Infectious diseases (1)
- Internal medicine (2)
- Neurology (2)
- Obstetrics & gynecology (3)
- Oncology (1)
- Psychology [licensed clinical psychologist] (1)
- Sexology (1)
- Urology (1)


ADMINISTRATION:

Administrative personnel are computer literate and have experience in on line data entry. They have been trained in HIPAA guidelines for clinical researchers and in how to conduct telephone screen interviews.

The study center is OSHA compliant. All line powered instruments that are connected to patients are inspected annually by certified biomedical technicians for electrical safety and calibration. The study center has written Standard Operating Procedures and prefers to work with a central IRB.

Typical regulatory and contract turn around time is 1-3 days.



Patient Demographics:

 Nearly 10 million people, or three-quarters of Florida's population, live within a 150 mile radius of Lee County, of which Fort Myers is the principal city. Forbes, Inc. and Money Magazine have recognized the Fort Myers Cape Coral area as one of the top places to live and do business in the country.

Lee County Population: 544,758 persons per the 2005 census

Lee County population by gender:
Gender: Percent:
Male: 49%
Female: 51%


Lee County population by age:
Age Group (years): Percent:
< 5 6%
5-18 21%
19-64 50%
> 65 23%



Copyright 2007 by Clinical Physiology Associates.