Overview

Clinical Physiology Associates (CPA), a multispecialty research group, has been conducting clinical trials for the pharmaceutical and medical device industries for 35+ years. The use of central IRBs and laboratories is preferred. Turnaround time for regulatory documents is less than three days. 

Research Experience

CPA Studies by Discipline – Numbers in parentheses refer to the number of different medicines studied. Some medicines were studied in more than one protocol.

Cardiology

• Angina pectoris, chronic stable (30)
• Congestive heart failure (9)
• Hypertension (41)
• Peripheral vascular disease (7)
• Ventricular arrhythmias (4)

Central Nervous System

• Alzheimer's disease (9)
• Migraine headaches (5)
• Seizure prophylaxis (4)
• Stroke (ischemic) (1)
• Tension headaches (1)

Dermatology

• Psoriasis (1)
• Tinea cruris (1)
• Tinea pedis (1)

Endocrinology

• Diabetes mellitus (7)
• Diabetic neuropathy (15)
• Obesity (2)

Gastroenterology

• Acid indigestion (1)
• Constipation – opiate induced (1)
• Gastroesophageal reflux (chronic) (1)
• Heart burn (1)
• Irritable bowel syndrome – diarrhea predominant (4)
• Irritable bowel syndrome – constipation predominant (1)

Genitourinary

• Acute urinary retention (1)
• Benign prostatic hyperplasia (11)
• Bladder cancer (superficial) (1)
• Genital herpes (3)
• Hypogonadism [male] (1)
• Impotence (erectile dysfunction) (15)
• Impotence (erectile dysfunction) in spinal cord injury (1)
• Impotence + dyslipidemia (1)
• Nocturia (1)
• Premature (rapid) ejaculation (1)
• Premature (rapid) ejaculation + erectile dysfunction (1)
• Prostatitis (chronic) (2)
• Sexual dysfunction (female) (6)
• Sexual dysfunction (male & female) (1)
• Urinary incontinence (urge, stress, mixed) (14)
• Urinary tract infection (complicated, uncomplicated)(5)

Geriatrics

• Chronic obstructive pulmonary disease (5)
• Congestive heart failure (9)
• Herpes zoster [shingles] (2)
• Insomnia (elderly) (4)
• Postherpetic neuralgia (9)

Gynecology

• Contraception (2)
• Osteopenia (1)
• Osteoporosis (postmenopausal) (5)
• Postmenopausal hormone replacement therapy (17)
• Postmenopausal hormone substitute replacement therapy (1)
• Premenstrual dysphoric disorder (PMDD) (2)
• Premenstrual syndrome (PMS) (1)
• Sexual dysfunction (women only) (6)
• Sexual dysfunction (women & men) (1)

Internal Medicine

• [KD1] Asthma (5)
• Bronchitis (4)
• Diabetic neuropathic ulcers (2)
• Heartburn (1)
• Hemorrhoids (1)
• Herpes labialis (cold sores) (4)
• Herpes zoster (shingles) (2)
• Hypercholesterolemia (2)
• Hypertension (41)
• Hypertension + osteoarthritis (1)
• Infectious diseases (miscellaneous) (22)
• Insomnia (2)
• Irritable bowel syndrome (2)
• Migraine headache (5)
• Obesity (2)
• Osteoarthritis (14)
• Pain management (18)
• Peripheral vascular disease (7)
• Post-herpetic neuralgia (9)
• Rheumatoid arthritis (1)
• Sea sickness (1)
• Skin and soft tissue infections (13)
• Smoking cessation (1)
• Tension headaches (1)
• Urinary tract infections (5)

Miscellaneous

• Venous stasis ulcers (2)

Neurology

• Alzheimer's disease (9)

Oncology

• Head and neck cancer (1)
• Prostate cancer (8)
• Prostate cancer prevention (1)
• Prostatic intraepithelial neoplasia (1)
• Superficial bladder cancer (1)

Ophthalmology

• Allergic conjunctivitis (1)
• Bacterial conjunctivitis (1)
• Corneal ulcer (1)
• Ophthalmic zoster (1)

Otolaryngology

• Sinusitis (1)

Pharmacology

• Hypogonadism (male) (1)

Surgery

• Alzheimer's disease (neurosurgery) (1)
• Decubitus ulcers (plastic and reconstructive surgery) (1)
• Diabetic neuropathic ulcers (plastic and reconstructive surgery (3)
• Postoperative pain management (neurosurgery) (3)
• Postoperative peridural fibrosis (neurosurgery) (2)
• Scar revision (plastic and reconstructive surgery (1)
• Seizure prophylaxis (neurosurgery) (4)
• Wound healing (plastic and reconstructive surgery)(2)

Pharmaceutical Companies worked with:

• 3M Pharmaceuticals
• A.H. Robins
• Abbott Laboratories
• Advanced Care Products
• Aeterna
• Alizyme Therapeutics
• Allergan Pharmaceuticals
• Alpha Therapeutic
• Astellas
• Astra Pharmaceuticals
• AstraZeneca
• Aventis
• Barr
• Bayer
• Bayer Health Care
• Berlex
• Biosante
• Boehringer Ingelheim Pharmaceuticals
• Boehringer Mannheim
• Bristol Myers Squibb
• Burroughs Wellcome
• Cellegy
• Ciba Geigy Pharmaceutical
• ConvaTec
• Corcept
• DepoMed
• DuPont Pharmaceuticals
• Duramed
• Eisai
• Eli Lilly
• Endo
• Ethical Pharmaceuticals
• Eunoe
• Forest Research
• FzioMed
• Galen
• G.D. Searle
• GlaxoSmithKline
• Glaxo Wellcome
• Grunenthal
• GTx
• Hisamitsu
• Hoechst Roussel Pharmaceuticals
• Hoffman LaRoche
• Human Geonome Science
• IASO Pharma
• ICI Pharmaceuticals
• Indivus
• International Medical Innovations
• Interneuron Pharmaceuticals
• Janssen Research Foundation
• Johnson & Johnson
• Key Pharm. Div. Schering
• Kissei
• Knoll
• Labopharm
• Lemmon
• Lidak
• Lilly
• Lorex Pharmaceuticals
• Lupin
• MacroChem
• Magainin Pharmaceuticals
• Marion Merrell Dow Laboratories
• Matrix
• McNeil Consumer Products
• McNeil Pharmaceutical
• Merck
• Miles Pharmaceuticals

• Myriad
• Neurobiological Technologies
• Neurocrine Biosciences
• NexMed
• Nix-O-Tine Pharmaceuticals
• NicOx
• Novartis
• Ono
• Organon
• Ortho-McNeil
• Palatin Technologies
• Parke-Davis
• Pfizer (Groton)
• Pfizer (New York)
• Pharmacia
• Pharmacia & Upjohn
• Procter & Gamble
• ProCyte
• Radius Health
• Reckett and Coleman
• Reed and Carnrick
• Revlon Health Care Group
• Rhone Poulenc Rorer Pharmaceuticals
• Roberts Pharmaceutical
• Roche Bioscience
• Roche Global Development
• R.W. Johnson Pharmaceutical Research Institute
• Salix
• Sandoz Pharmaceuticals
• Sangamo
• Sankyo U.S.A.
• Sanofi Synthelabo
• Schering Corporation
• Schering Plough Research Institute
• Schwarz Bioscience
• Schwarz Pharma
• Searle
• Senju
• Serono Laboratories
• SmithKline and French Laboratories
• SmithKline Beecham Pharmaceuticals
• Solvay
• Sterling Winthrop
• Stuart Pharmaceuticals
• Sucampo
• Sugen
• Syntex Laboratories
• Takeda America
• Takeda Global
• TAP Holdings
• Tioga
• Toyama
• UCB Pharma
• Unimed
• Unither
• Upjohn
• Upsher Smith
• USV Pharmaceutical
• Vivus
• W.F. Merchant Pharmaceutical
• Wallace Laboratories
• Wyeth Ayerst Laboratories
• Wyeth Research
• Xanodyne
• XenoPort
• Yamanouchi
• Zeneca

CROs worked with from 1978 to the present:

• Barton & Polanski
• Besselaar Associates
• BioCLin
• BioDecision Laboratories
• BioPharm Clinical Services
• Clinical Research Consultants
• Clinical Research Group
• Clinical Research Institute
• Clinimetrics
• Clinical Trial Management Services
• ClinTrials
• Constella
• Coromed
• Covalent Research Alliance
• Covance
• Drug Research and Analysis
• Health Decisions
• i3 Research
• IBRD
• ICON Clinical Research
• INC Research
• Ingenix
• Institute of Clinical Pharmacology

• MDA Pharma
• MDS Pharma Services
• Medex
• Medical and Technical Research Associates
• Metropolitan Research Associates
• Minnesota Clinical Study Center
• Omnicare
• Oxford Research International
• PACT
• Paragon Biomedical
• Parexel
• Pharmaco
• Pharmaceutical Product Development
• Pharmaceutical Resource
• PharmaKinetics Laboratories
• PharmaNet
• Phoenix International
• PPD Development
• PPD Pharmaco
• Quintiles
• Radiant Development
• Resource Solutions
• Scirex

Facility Description

Physical Plant

• Examination rooms (3)
• Laboratory work areas (1)
• Conference rooms (monitor work areas) (3)
• Double-locked, limited-access, temperature-controlled drug storage room with
  • Shelves
  • Counter tops
  • Refrigerator/freezer
  • Steel, locked controlled-substance cabinet
• Physician dictation area with X-ray view box
• Video surveillance cameras with remote access
• Coordinators’ offices (3)
• Administrative offices (3)
• Spacious waiting room
• Rest rooms (2)

Specialized Scientific Equipment

Urology

• Dantec Urodyn 1000 urine flowmeter (2)
• Diagnostics ultrasound bladder scan (2)
• Rigiscan Plus (with computer interface)
• Infusion equipment (IMED Gemini PC-1) (2)

Cardiovascular

• Parks Penilab V (noninvasive vascular lab)
• Parks hand-held transcutaneous Doppler flowmeter
• Parks photoplethysmograph and miscellaneous instruments, toperform noninvasive assessments of the peripheral and penile circulations
• Hokanson automatic cuff inflator
• Nihon Kohden Cardiofax V (12 lead EKG) (2)
• Novametrix transcutaneous oxygen monitor (2 channel)
• Omron digital blood pressure monitor (3)
• Quinton Exerdop™

Anthropometry

• Harpenden stadiometer

Gynecology

• Vabra endometrial biopsy aspirator and related instruments

Pulmonary

• KoKo spirometer with computer interface

Laboratory

• Refrigerator/ freezer -20°C (various)
• Clinical centrifuges
• Refrigerated centrifuge (Jouan CR412)
• Test tube shaker
• Leitz binocular optical microscope
• Temp-Blok module heater
• Corning Biotrack 516
• Dry ice is available daily

Computers and Related Items

• High-speed internet and fax
• Intra-office network
• Computers

Investigator Experience

Kevin M. Fleishman, MD
Board Certified Obstetrics and Gynecology

Pedro Ylisastigui, MD
Board Certified Internal Medicine

Sergio Mather, MD
Board Certified Internal Medicine and Endocrinology

Natasha Bower, MD
Board Certified Obstetrics and Gynecology

Anais Badia, DO
Board Certified Dermatologist

Staff Expertise

The study center is staffed with full-time study coordinators, coordinators’ assistants and administrative personnel. All coordinators and their assistants are trained in shipping infectious and biological substances as per 49 CFR section172,702 & IATA regulations. All staff members are trained in basic life support (CPR), HIPAA guidelines for clinical researchers and the protection of human research subjects.

Patient Demographics

• Population estimate: 625,124
• Persons 65+ years of age: 150,029
• Females 18+ years of age: 255,050
• Study center database: 5,071
• Female patients 3,551
• Male patients 1,520
• Persons 65+ years of age: 2,136
• Male patients 65+ years of age: 746
• Female patients +65 years of age: 1,390

(Source: July 2009 University of Florida BEBR)

Other Information

IRBs utilized:

• Chesapeake Research Review
• Coast Institutional Review Board
• Copernicus Group
• Essex Institutional Review Board
• Independent Investigational Review Board
• Integ Review Ethical Review Board
• Institutional Review Board for Clinical Physiology Associates (disbanded 1993)
• Lee Memorial Health System Institutional Review Committee
• New England Institutional Review Board
• Quorum Review
• RCRC Institutional Review Board
• Schulman IRB
• St. David’s Human Research Review Board
• Sterling IRB
• Western Institutional Review Board