Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Endocrinology
Family Medicine
Gastroenterology
Immunology
Internal Medicine
Musculoskeletal
Nephrology
Neurology
Obstetrics/Gynecology (Women’s Health)
Ophthalmology
Orthopedics/Orthopedic Surgery
Pediatrics/Neonatology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Sleep
Urology

Center Overview

Clinical Research of West Florida, Inc. ("CRWF") provides improved and innovative healthcare opportunities to residents of the Tampa Bay area through clinical research studies. CRWF works with board certified community-based physicians to conduct Phase I - IV clinical research trials.

Clinical Research of West Florida is an independent clinical research site with two locations in the Tampa Bay area. The Clearwater office is situated in a 5,000 square foot dedicated research facility located 20 minutes from Tampa International Airport and in close proximity to three major hospitals. The Tampa research clinic, a 4,200 sq ft dedicated research facility, is located five minutes from St. Joseph's Hospital in the heart of the city. CRWF works with Principal and Sub-Investigators in the Pinellas and Hillsborough counties to conduct clinical research studies in a range of specialty areas.

Performance Metrics

Number of Studies Conducted: 200+
Number of Studies Actually Completed: 193
Number of Active Patients in the Database: 3,000+
Regulatory Submission Turn-Around Time: 2 Week(s)
Average Number of Total Patients Enrolled: 20
Average Percent of Total Patients Randomized: 90%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 97%
EDC Capabilities: Yes

Clinical Research Experience

Clinical Research of West Florida was founded in 1995 and has participated in more than 450 clinical trials with leading pharmaceutical companies such as Abbott Laboratories, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squib, Dey, Eli Lilly & Company, Forest Research Institute, Genentech, GlaxoSmithKline, Johnson & Johnson, Merk & Co., Novartis, Novo Nordisk, Pfizer, Roche and Sanofi-Aventis, Takeda. All of our Principal and Sub-Investigators are board-certified/eligible and have extensive study experience. The current staff includes 13 trained study coordinators, two full time ARNPs, two regulatory managers, laboratory manager and office support staff.

Therapeutic Areas include the following:

• Arthritis - Osteoarthritis, Rheumatoid Arthritis
• Bronchitis - chronic
• Cardiovascular - Hypertension, CHF, Anti-Platelet Aggregation, Hypercholesterolemia, IVUS, CAD, Atherosclerosis
• Central Nervous System - Migraine Headaches, Post Herpetic Neuralgia, Fibromyalgia, Diabetic Neuropathies,
• Dermatology - Psoriasis, Wound Healing, Rosacea, Acne, Tinea Capitis
• Endocrinology - diabetes type II
• Gastroenterology - GERD, NUD, Ulcers, Gastritis, IBS, Crohn’s Disease, Diverticulitis, Gout
• Ophthalmology - Glaucoma, Dry Eye, Corneal Diseases, Conjunctivitis, Macular Degeneration
• Orthopedics - Joint Replacement, Tinnitus, Distal Radius Fracture
• Pain Management - Acute and Chronic Pain Syndromes, Management of Intrathecal Pumps, Opioid Induced Bowel Dysfunction, Sleepiness in Opioid Therapy
• Psychiatry - , Insomnia, Anorexia, MDD, GAD
• Respiratory - COPD, Sinusitis, Asthma, Rhinitis
• Urology - BPH, Impotence, Over Active Bladder
• Women’s Health - HRT, Bacterial Vaginitis, Hot Flushes, Endometriosis, Sexual Dysfunction, Fibroids, Dysmenorrhea, Oral Contraceptive, Osteoporosis, HPV

A sampling of the Sponsors with whom CRWF has worked is listed below:

• 3-M Pharmaceuticals, Abbott, Acambis, Achillion, Adams Respiratory Therapeutics, Adolor, Agouron, Alizyme Therapeutics, Allergan, Almirall, Altana, Alza, Amgen, Amylin, Anesvia, Arakis, Asterand, AstraZeneca, Asubio, AtheroGenics, Atrix, Aventis Pharmaceutical Products, Bavarian Nordick, Bayer, Berlex, Biovail, Boehringer Ingelheim, Bristol-Myers Squibb, Cardiome, Celltech R&D, Centocor, Cephalon, Chiesi, Cipher Pharmaceuticals, Cita Neuro Pharmaceuticals, Clay Park, CPEX, CV Therapeutics, Daiichi Sankyo Pharmaceuticals, Depomed, Development Partners, DEY L.P, DOV, Eli Lilly & Company, Endo Pharmaceuticals, Epix, Esperion Therapeutics, Ferring, Forest Research Institute, G&W Laboratories, Inc., Galen Holdings, GlaxoSmithKline, Genentech, , Genomics Collaborative, Hisamitsu, Immune Response Corp., Incyte Pharmaceuticals, Indevus, Inflabloc, Interferon Sciences, ISIS, Johnson & Johnson, Kalypsis, Keryx, King Pharmaceuticals, KV Pharmaceuticals, Map Pharmaceuticals, MeadJohnson Nutritionals, Medeva, Medgenex, The Medicines Company, Merck & Co., Merz, Metaphore Pharmaceuticals, Mitsubishi, MPEX Pharmaceuticals, Myogen, NanoBio, Napo Pharmaceuticals, Naryx, Neurocrine Biosciences, NeurogesX, Neuromed, Nitro-Med, Novartis, Novo Nordisk, NPS Allexia Corp., ONO Pharma , Organon, Ortho Biotech, , OrthoLogic, Ortho McNeil, Osiris Therapeutics, Otsuka, Pain Therapeutics, Parke Davis, Pearl Therapeutics, Penwest Pharmaceuticals, Perlegen, Pfizer, Pharmacia, POZEN, Procter and Gamble, Progenics, Purdue Pharma, Regeneron, Renovis, Replidyne, Resverlogix, Roche, Roxane, R.W. Johnson, Salix Pharmaceuticals, Sandoz, Sankyo, Sanofi-Aventis, Sanofi Synthelabo, Santarus, Schering-Plough, Schwarz Biosciences, , Searle, Sepracor, SeraCare Life Sciences, Serono, Shionogi, Shire, Solvay, Spherix, Sucampo, Takeda, TAP Pharmaceuticals, Taro Pharmaceuticals, , Teva, Travanti Pharmaceuticals, UCB-Pharma, United BioSource, Waratah Pharmaceuticals, Watson, Whitehall-Robins, Wyeth-Ayerst, XOMA, XTL Development, Yamanouchi, Zogenix

A sampling of the CROs with whom CRWF has worked is listed below:

• AAI Pharma, Advanced Biologics, Anaclim, Beardsworth, CATO Research, Chiltern, Clinimetrics, , , ClinTrials Research, Clinicor, Inc., Concentrics, Covalent Research Alliance, Covance, DCRI, DermTech, Essential, Genexion, Global CINRG, Health Decisions, Healthcare Products, Henry Ford Consortium, i3 Research, IBAH, ICON Clinical Research, Ingenix, Innovex, Integrium, Interspond, Inveresk, ISS, Kendle, LBR Regulatory, MDS Pharma Services, Medifacts, Medpace, Novum Pharmaceuticals, Omnicare, Origin, Paragon Biomedical, Parexel, Partners Healthcare System, PCRS, PharmaNet, PharmaResearch, PharmaSeek, PPD, Premier Research Worldwide, PRA, ProTrials, Quintiles, Research Point, , Research Scientists, Resource Solutions, , Scirex, Synteract,TKL Research, Transition Therapeutics, Triligent International, UBC,Worldwide Clinical Trials

A sampling of the Central IRBs with whom CRWF has worked is listed below:

• Aspire, Biomedical Research, Chesapeake Research, Copernicus, Essex, Ethical Review Committee, Goodwyn, IMTCI, Independent, IntegReview, Midlands, NEIRB, Novum Independent IRB, Ohio Valley, Quorum Review, Research Consultants Review Committee, Research Triangle Park, Schulman, Sterling, Western

A sampling of the Central Laboratories with whom CRWF has worked is listed below:

• AMC Medical Laboratory, Avantix, BARC, BioMedical, BMS, Cirion, Clearstone, Clinical Reference Laboratory, Covance, CRL Medinet, Dianon, Esoterix, ICON, LabConnect, LabCorp, Mayo, MDS Pharma, Medpace, Medtox, PPD, , Quest, Quintiles, Sonic, Spectra, Synarc, Transition Therapeutics

Facility Description

Clinical Research of West Florida's Clearwater office is located in a 5,000 square foot handicap accessible facility. The research center is within five miles of three major hospitals, easily accessible from Interstate 75, and 20 minutes from Tampa International Airport.

• Two patient exam rooms, each equipped with a 12-lead Burdick EKG machine
• Two Spirometry rooms
• Patient lounge for extended visits
• Comfortable patient waiting area
• CLIA certified laboratory
• Individual coordinator offices
• Private monitoring rooms with telephone access
• Daily Fed Ex
• Remote Data Entry capabilities and experience
• High speed 24 hour fax on a dedicated line
• Comprehensive telephone system with voice mail and 24/7 response from a staff member
• Completely wired for Internet and E-mail access
• Networked laptop computers at each staff member’s desk with automated daily backup
• Television, CD/DVD player for patient education/entertainment
• On-site archiving

Clinical Research of West Florida's - brand new Tampa office is located in a 4,200 sq ft., handicap accessible facility, fifteen minutes from St. Joseph’s Hospital in the heart of the city. The research center is located fifteen minutes from Tampa International Airport.

• Two patient exam rooms, each equipped with a 12-lead Burdick EKG machine
• Comfortable patient waiting area
• CLIA certified laboratory
• Individual coordinator offices
• Private monitoring room with telephone and internet access
• Daily Fed Ex pick-up
• Remote Data Entry capabilities and experience
• High speed 24 hour fax on a dedicated line
• Comprehensive telephone system with voice mail
• Completely wired for Internet and E-mail access
• Networked laptop computers at each staff member’s desk with automated daily backup
• Television and VCR for patient education/entertainment
• On-site archiving

Investigator Experience

Board certified physician investigators are available in the following specialty areas:

• Allergy/Immunology
• Dermatology
• Ear, Nose and Throat
• Endocrinology
• Gastroenterology
• Geriatrics
• Family Practice
• Internal Medicine
• Ophthalmology
• Orthopedics
• Neurology
• Pain Management
• Psychiatry/Psychology
• Pulmonology
• Rheumatology
• Women’s Health

Staff Expertise

Name	Clinical Research Role	Years of Clinical Research Experience
Lynne Merriam, ARNP-C, CCRC	Founder & Director of Clinical Operations / Sub-I	19
Aydin Keskiner, BS	President & CEO	9
Sara McGilvary, AA, CCRC	Vice President, Regulatory, Unblinded Pharmacist	16
Barbara Keskiner, BS	Regulatory Affairs Director	9
Leonard J. Dunn, MD	Medical Director (Pulmonology) / PI	21
Elias M. Kolettis, DO, MS	Medical Director (Internal Medicine) / PI	10
Paul Lunseth, MD	Medical Director (Orthopedics) / PI	12
Lon D. Lynn, DO	Medical Director (Family Practice)  / PI	17
Jack Parrino, MD	Asthma & Allergy / Sub-I	19
Heather Giard, ARNP-C, CRC	ARNP / Sub-I / Clinical Research Coordinator	4
Debbie Atkins, MS, CRC	Clinical Research Coordinator	10
Christina Hasse	Laboratory Manager / Assistant Coordinator	1
Cindy Hintz, BSN, RN, CRC	Clinical Research Coordinator	2
Amy Howard, RN, CRC	Clinical Research Coordinator	3
Karen Main, A.A.	IT & Operations Manager	12
Jessica Mazzarese	Marketing amp; Regulatory Affairs Manager	4
Matthew McGilvary	Data Entry & Web Specialist	2
Sarah Moore, LPN, CCRC	Clinical Research Coordinator	13
Jamee Moran, MS, CCRC	Clinical Research Coordinator	5
Kristin Schaller, MS, CCRC	Clinical Research Coordinator	3
Tara Shepard, BS, CRC	Clinical Research Coordinator	4
Stephani Shively	Laboratory Director	5
Melonie Tournai, LPN, CRC	Clinical Research Coordinator	4
Barbara Toth, MS, RD, LD/N	Registered Dietitian	1
Kyndall Walker, BS, CRC	Clinical Research Coordinator	5

All study coordinators are trained and/or certified in GCP/ICH compliance, CRC role and responsibilities, Human Subject Protection, HAZMAT (shippind and handling of dangerous goods) and CPR. Staff capabilities include: ECG, Blood pressure (certification for Holter and ambulatory monitoring), Siprometry, PFTs, Inhalation therapy, IV infusion, PK sampling, Phlebotomy, Continuous glucose monitoring, Dietary counseling, Patient education, Pain assessments and evaluations (WOMAC, NRS, OOWS), Joint assessments, Psychiatric ratings (KBIT, CDRS, CYBOCS, KSADA, MINI, HADS, HAM-D), Gram stains (sputum), H. Pylori flexure testings, Skin debridement (pressure ulcers), Wound dressing, DXA scan, X-Ray.

Patient Demographics

Patient recruitment is facilitated through our proprietary patient database, investigator(s)’ private practice, non-investigator physician referrals, liaisons with community services, and through radio, newspaper and television advertising when appropriate. There are more than 2 million people living in the Tampa Bay area. The population is ethnically diverse and median age is 44 years for Pinellas County and 36 years for Hillsborough County..

Other Information

If you are a patient interested in enrolling in a clinical trial conducted by this site, or if you wish to receive additional information, please contact:

Sara McGilvary
Vice President
Clinical Research of West Florida, Inc.
2147 NE Coachman Road
Clearwater, FL 33765-2616
Phone: 877-YES-CRWF
Fax: 727-461-7793
E-mail: smcgilvary@crwf.com

Barbara Keskiner
Regulatory Affairs Director
Clinical Research of West Florida, Inc.
5115 N. Armenia Avenue
Tampa, FL 33603
Phone: 813-870-1292, ext. 122
Fax: 813-870-1252
Email: bkeskiner@crwf.com

Sponsors, CROS, Monitors, please contact:

Aydin Keskiner
President and CEO
Clinical Research of West Florida, Inc.
2147 NE Coachman Road
Clearwater, FL 33765-2616
Phone: 727-466-0078 ext. 228
Fax: 727-461-7793
E-mail: akeskiner@crwf.com

Contact Center

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

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