Clinical Physiology Associates, a multispecialty research group, has been conducting clinical trials for the pharmaceutical and medical device industries for 27 years. The company has had 2 FDA audits, and has not received a Form 483. The use of central IRBs and laboratories are preferred. Turn around time for regulatory documents is less than 3 days. 

CPA Studies by discipline

Numbers within ( ) 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) Prostate cancer (6) Prostate Cancer Prevention (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 Acid indigestion (1) Angina pectoris (30) Asthma (5) Bronchitis (4) Chronic obstructive pulmonary disease [COPD] (5) Congestive heart failure [CHF] (9) Constipation- opiate induced (2) Diabetes mellitus (7) Diabetic neuropathy (15) Internal medicine, contd. Diabetic neuropathic ulcers (2) Gastroesophageal reflux (1) Genital herpes (3) 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) Insomnia [elderly] (4) 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 & soft tissue infections (13) Smoking cessation (1) Tension headaches (1) Urinary tract infections (5) Miscellaneous Sinusitis (2) Venous Stasis Ulcers (2) Neurology Alzheimer's disease (9) Oncology Head & neck cancer (1) Prostate cancer (8) Prostate cancer prevention (1) Prostatic intraepithelial neoplasia (PIN) (1) Superficial bladder cancer (1) Ophthalmology Allergic conjunctivitis (1) Bacterial Conjunctivitis (1) Corneal Ulcer (1) Ophthalmic Zoster (1) Otolaryngology Head & neck cancer (1) Sinusitis (1) Pharmacology Hypogonadism (male) (1) Surgery Alzheimer's disease [neurosurgery] (1) Decubitus ulcers [plastic & reconstructive surgery] (1) Diabetic neuropathic ulcers [plastic & reconstructive surgery] (3) Postoperative pain management [neurosurgery] (3) Postoperative peridural fibrosis [neurosurgery] (2) Scar revision [plastic & reconstructive surgery] (1) Seizure prophylaxis [neurosurgery] (4) Wound healing [plastic & reconstructive surgery] (2)

Pharmaceutical Companies worked with:

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

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

Contract Research Organizations Worked With: 1978-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, Inc. ClinTrials Constella Coromed Covalent Research Alliance Covance Drug Research and Analysis Corporation Health Decisions i3 Research IBRD ICON Clinical Research INC Research Ingenix Institute of Clinical Pharmacology Integrated Therapeutic Group In Vivo KAI Kendle International Kendle Research Kern McNeil LBR Regulatory & Consulting

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 Corp. PharmaKinetics Laboratories, Inc. PharmaNet Phoenix International PPD Development PPD Pharmaco Quintiles Radiant Development Resource Solutions Scirex StatProbe, Inc. Target Research Associates Theradex Therapeutic Management The Phoenix Premier Research Schiff & Company

• Examination rooms (4)
• Laboratory work areas (2)
• Conference rooms [monitor work areas] (3)
• Double locked limited access drug storage room with
  • Shelves
  • Counter tops
  • Refrigerator/ freezer
  • Steel locked controlled substance cabinet
• Physician dictation area with X-ray view box
• Computer room (on line data entry)
• Coordinators’ offices (5)
• Administrative offices (3)
• Spacious waiting room
• Rest rooms (3)

Urology

• Dantec Urodyn 1000 urine flowmeter (2)
• Diagnostics Ultrasound Bladder Scan (2)
• Rigiscan Plus (with computer interface)

Cardiovascular

• Parks Penilab V (non- invasive vascular lab)
• Parks hand-held transcutaneous Doppler flowmeter
• Parks photoplethysmograph and miscellaneous instruments to perform non-invasive 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 & related instruments

Pulmonary

• KoKo Spirometer with computer interface

Laboratory (dry ice is available daily)

• Refrigerator/ freezer -20 degrees Celsius (various)
• Clinical centrifuges
• Refrigerated centrifuge (Jouan CR412)
• Test tube shaker
• Leitz binocular optical microscope
• Temp-Blok module heater
• Corning Biotrack 516

Photographic

• Yashica Dental-Eye II

Computers & Related Items

• DSL line (all coordinators have internet access)
• intra- office network
• Computers: Gateway & Dell
• Facsimiles
  • Xerox WorkStation 390
  • Sharp FO-4500
  • HP 1010
• Copy machines
  • Minolta DiALTA with sorter

Demographics of the area (2005 Census Bureau)

• Population estimate 544,758;
  • Persons ≥ 65 YOA 123,660;
  • Females ≥ 18 YOA 276,206 (50.7% of population).
• Study Center Database,
  • Total Number of Patients 6,083;
    • # female patients 3,816;
    • # male patients 2,170;
    • # persons ≥ 65 YOA 4,111,
    • # male patients ≥ 65YOA 2,323;
    • # female patients ≥ 65YOA 1,699.

David D. Michie, PhD.
Board Certified Sexology

Ronica Kluge, MD.
Board Certified Internal Medicine

B. Koneru, MD.
Board Certified Internal Medicine

Douglas Newland, MD. Certified Neurology

Mary Yankaskas, MD.
Board Certified Obstetrics & Gynecology

Harris Bonnette, MD.
Board Certified Neurology

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 & biological substances as per 49 CFR section 172,702 & IATA regulations. All staff members are trained in basic life support (CPR), HIPAA guidelines for clinical researchers and the protection of human research subjects.

Demographics of the area (2005 Census Bureau)

• Population estimate 544,758;
  • Persons ≥ 65 YOA 123,660;
  • Females ≥ 18 YOA 276,206 (50.7% of population).
• Study Center Database,
  • Total Number of Patients 6,083;
    • # female patients 3,816;
    • # male patients 2,170;
    • # persons ≥ 65 YOA 4,111,
    • # male patients ≥ 65YOA 2,323;
    • # female patients ≥ 65YOA 1,699.

Institutional Review Boards Utilized

• Chesapeake Research Review, Inc.
• Coast Institutional Review Board
• Copernicus Group
• Essex Institutional Review Board
• Independent Investigational Review Board, Inc.
• 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
• Research Consultants Review Committee Institutional Review Board (RCRC IRB)
• Schulman Associates Institutional Review Board
• St. Davids Human Research Review Board
• Sterling Institutional Review Board
• Western Institutional Review Board

For more information, please contact:

Dr. David Michie
President
Clinical Physiology Associates
4110 Center Point Dr., Suite 219
Ft. Myers, FL 33916 USA
Phone: 239-936-4421
Fax: 239-936-2865
E-mail:

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.

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Last updated on August 21, 2008