Research Center Profile:
Cardiology/Vascular Diseases
Mission Statement
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.
Type of Research Center
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.
Number of Studies Conducted:
613 Number of Studies Actually Completed:
567 Number of Active Patients in the Database:
7,200+ Regulatory Submission Turn-Around Time:
1 Week(s) Average Number of Total Patients Enrolled:
15 Average Percent of Total Patients Randomized:
70% Average Percent of ‘Completed’ Studies that met Enrollment Goals:
87% EDC Capabilities:
Yes
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
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
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
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 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..
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 McGilvarysmcgilvary@crwf.com
Barbara Keskinerbkeskiner@crwf.com
Sponsors, CROS, Monitors, please contact:
Aydin Keskinerakeskiner@crwf.com
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.
