Study Experience

Study Experience

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Study Experience

Investigator Contact Experience
Acute Chronic Low Back Pain
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI has conducted over 550 clinical trials and is an ACRP Certified Principal Investigator. Clinical research coordinators are also ACRP certified.
AMR Cardiovascular Experience
Duane G. Wombolt, MD Edith Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted over 110 cardiovascular studies, including hypertension (75), hyperlipidemia, atrial fibrillation, coronary artery disease and other cardio trials. Large database of patients with hypertension and hyperlipidemia. Associated with a large cardiology practice as well as a large cardio-thoracic surgery practice. PI has over 30 years research experience and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are ACRP certified.
AMR Dermatology Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has successfully conducted numerous acne, tinea pedis, rosacea, and plaque psoriasis studies. CRAT has a large database of subjects with dermatological conditions/diseases. 2013-14 stats Acne goal 20/ 25 randomized Acne goal 40/ 43 randomized Acne goal 20/ 20 randomized (enrollment capped) Tinea pedis goal 50/ 63 randomized PI has over 40 years clinical research experience and is a Certified Principal Investigator by ACRP.
AMR Devices and Diagnostics
Duane Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org 1 smoking device study – 45 enrolled/completed 30 days enrollment 1 diabetic pen device study 45 enrolled (capped by sponsor) 2 days enrollment. 1 nasal swab study for influenza 100 enrolled 2.5 weeks
AMR Diabetes Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted 15 diabetes studies and has over 950 diabetics in database. PI has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are also certified by ACRP. Sub-I has a Fellowship in Endocrinology. We also work with an endocrinology group practice.
AMR Dyslipidemia Experience
Duane Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted over 15 dyslipdemia studies and has over 1,100 patient databases with dyslipidemia. Associated with a large cardiology practice as well as a large cardiovascular surgery practice. PI has over 30 year’s clinical experience and is a certified principal investigator by the ACRP. Clinical Research Coordinators are ACRP certified.
AMR Fibromyalgia Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org Site has many fibromyalgia patients in database. Very experienced PI has conducted over 450 trials in varying indications and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are ACRP certified.
AMR Fibromyalgia Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org Site has many fibromyalgia patients in database. Very experienced PI has conducted over 450 trials in varying indications and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are ACRP certified.
AMR Geriatric Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT is affiliated with a neuropsychologist who is active with the Alzheimer’s Association and has many AD patients. CRAT has conducted many studies in geriatric patients including hypertension, hyperlipidemia, and vaccines. PI has over 30 years clinical research experience and is an ACRP Certified Principal Investigator. Clinical research coordinators are also certified by ACRP.
AMR GI Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted 11 GI trials including 1 GERD, 1 Erosive Esophagitis, 2 IBS-D, 2 IBS-C, 1 chronic constipation, 1 dyspepsia, 2 ulcers, and 1 heartburn. Gastroenterologists serve as PIs. Certified clinical research coordinator with over 10 yrs GI clinical research experience.
AMR Hypertension Summary
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted 75 HTN trials. ABPM experience too. Database of over 1900 patients with hypertension. PI has over 30 years clinical research experience and is a Certified Principal Investigator by ACRP. Clinical research coordinators are ACRP certified too.
AMR Infectious Disease Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are ACRP certified. Conducted Phase II and III flu treatment studies. Not interested in HIV or TB studies. Conducted 23 vaccine studies and very interested in continuing work with vaccine clinical trials.
AMR Men’s Health Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI, board certified in internal medicine and nephrology, has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. Site database of thousands of interested volunteers. A recent medical marketing search reveals 6932 men in the Tidewater area with the diagnosis of ED. Staff includes marketing coordinator, patient recruiter, regulatory document specialist, nurse practitioners, directors, research assistant and certified clinical study coordinators.
AMR Migraine Study Experience
Duane Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted 3 migraine studies. Over-enrolled in acute treatment of migraine in injection drug and met enrollment for inhaled delivery system migraine study. Database over 450 migraine subjects. PI has over 30 years clinical research experience and is a certified principal investigator by the ACRP. Clinical research coordinators are also ACRP certified.
AMR Nephrology Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI board certified in nephrology and internal medicine, has conducted over 100 nephrology studies including chronic kidney disease, dialysis, end stage renal disease and anemia. Pi has over 30 years clinical research experience and is a Certified Principal Investigator by ACRP.
AMR Neurology Study Experience
Duane G. Wombolt, MD Edith Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted 3 migraine, 1 insomnia, and 1 post herpetic pain studies. CRAT works with a 12-bed certified sleep lab. CRAT also works with a neuropsychologist who has access to patients with Alzheimer’s Disease and other neurological diseases. The site database has over 10,000 potential subjects. Dr. Wombolt has conducted over 500 clinical trials and is a certified principal investigator by the ACRP. Clinical research coordinators are also ACRP certified.
AMR Ophthalmology Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI has over 30 years clinical research experience and is an ACRP Certified Principal Investigator. Clinical Research Coordinators are ACRP certified. Worked with several ophthalmologists on clinical trials.
AMR Orthopedic Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are ACRP certified. CRAT works with a large orthopedic practice.
AMR Osteoporosis Study Experience
Duane G. Wombolt, MD Lois Shafter Asimos 757-627-7446 PI has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. All clinical research coordinators are certified by the ACRP. Affiliated with large OB/GYN practice. Access to DEXA scanner.
AMR Otolaryngology Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are ACRP certified. Affiliated with Medical Director of Hearing and Balance Center.
AMR Pediatric Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted 3 pediatric vaccine trials; meningococcal vaccine, MMRV vaccine and Tdap vaccine with pediatricians’ group practice. PI has over 30 years clinical research experience and is an ACRP Certified Principal Investigator. Clinical Research Coordinators are ACRP certified. Site very experienced conducting vaccine studies in minor and adult subjects.
AMR Psychiatry Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are ACRP certified. We work with a neuropsychologist experienced in conducting Alzheimer’s Disease studies.
AMR Pulmonary Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted 4 HAE studies, 3 asthma studies and 2 CAP studies. PI has over 30 years clinical research experience and is ACRP certified Principal Investigator. Clinical Research Coordinators are ACRP certified.
AMR Restless Leg Syndrome Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI has over 30 years clinical research experience and is an ACRP Certified Principal Investigator. Clinical Research Coordinators are ACRP certified. Site is affiliated with neuropsychologist and sleep center.
AMR Rheumatology Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org PI has over 30 years clinical research experience including OA and gout studies (exceeded enrollment) and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are ACRP
AMR Sleep Disorders Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org One insomnia study and affiliated with accredited 12 bed sleep lab. PI has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. Clinical Research Coordinators are certified by the ACRP. Coordinator with experience in sleep disorder clinical trials. Database with hundreds of patients with insomnia/ sleep disorders.
AMR Smoking Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has successfully conducted 4 smoking studies. Enrolled 78 in two weeks; contracted for 25. In the second study, met capped enrollment of 30 for a pilot study. In third study, first site to enroll. Met goal of 50 and allowed to exceed enrollment for total of 67. The fourth trial is ongoing. To date the site has enrolled 183 smokers in this trial. The site has excellent retention rate of 96%. Site database of over 4,200 smokers. Certified smoking cessation counselors and psychologists. Full-time marketing coordinator and patient recruiter. PI and clinical research coordinators are certified by ACRP. Site has a carbon monoxide monitor. Virginia is a top tobacco producing state.
AMR Urology Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org Site has conducted 8 urology studies in the areas of overactive bladder, benign prostatic hypertrophy, lower urinary symptoms, infection, and nocturia. Site is well versed in teaching paper and electronic diaries to study participants. Site has a uroflometer on site. PI, board certified in internal medicine and nephrology, has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. We work with area board certified OB/GYNs. Staff includes marketing coordinator, patient recruiter, regulatory document specialist, nurse practitioners, directors, research assistants and certified clinical research coordinators.
AMR Vaccine Study Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted 27 vaccine studies, as follows: 1. Flu vaccine – Phase III – healthy volunteers adults 18-49 yrs old 2. Flu vaccine – Phase III – healthy volunteers adults 50 yrs 3. Flu vaccine – Phase III – healthy volunteers adults 18-49 yrs 4. Flu vaccine – Phase III – healthy volunteers elderly 65 yrs and older 5. Flu vaccine – Phase III – healthy volunteers adults 18-49 yrs old 6. Flu vaccine – Phase III – healthy volunteers adults 50 yrs and older 7. Flu vaccine – Phase III – healthy volunteers adults 18-49 years old 8. Botulism vaccine – Phase II – healthy volunteers adults 18-55 yrs 9. Pneumonia vaccine – Phase III – healthy volunteers elderly 70 yrs and older 10. TDAP vaccine – Phase IIIb – healthy volunteers adults 19 yrs and older 11. TDAP vaccine – Phase IIIb – healthy volunteers adults 19 yrs and older 12. TDAP vaccine – Phase IIIb – healthy volunteers adults 19 yrs and older 13. Staph vaccine – Phase IIb/III – cardio. patients 18 yrs and older 14. Staph vaccine – Phase IIa -dialysis patients 18 – 80 yrs old 15. Staph vaccine – Phase III – orthopedic patients 16. Staph vaccine – Phase III – cardio. patients 17. Staph vaccine – Phase III – dialysis patients 18. Smoking cessation vaccine – Phase III – healthy volunteers 18-65 yrs old 19. Hepatitis B vaccine – Phase III – chronic kidney disease patients 18-70 yrs old 20. Hepatitis B vaccine – Phase III – healthy volunteers 40-70 yrs old 21. Meningococcal – Phase III – healthy volunteers 9 months old and 12 month olds 22. MMRV vaccine – Phase II – healthy volunteers 12 – 14 months old 23. Tdap/Dtap vaccine – Phase III – healthy volunteers 4-6 yrs old 24. Flu vaccine – Phase IV – healthy volunteers elderly 65 yrs of age and older 25. Hepatitis B vaccine – Phase III- 18-65 extension 26. Chronic Kidney Disease patients – Phase III – 18-70 yrs of age extension 27. Meningitis B vaccine – Phase III – 11-17 yrs of age 28. Influenza vaccine Phase III ages 65 + 2011 29. Influenza Vaccine Phase III ages 65 + 2012 30. Smallpox vaccine Phase III ages 18 -40 2013 31. Influenza vaccine Phase IV ages 18 – 50 2014 32. Influenza vaccine Phase III ages 50 + 2014 33. TDap vaccine 18 + 2015 Experience conducting large enrolling vaccine studies (exceeding enrollment). Large database. Receive compliments on quality data. Dr. Wombolt is board certified in Internal Medicine and Nephrology. He is a Certified Physician Investigator by the ACRP. Clinical research coordinators are certified by the ACRP. Site also employs regulatory document specialist, patient recruiter, and marketing coordinator. Locked freezers and refrigerators, including a Norlake Scientific 50 ft cubic capacity refrigerator, are connected to back-up generator in the event of power outages. Site located on medical campus in region of 1.6 million people.
AMR Weight Management Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org Site has obesity/weight management experience and many interested subjects. PI has over 30 years clinical research experience and is a Certified Principal Investigator by the ACRP. Registered dieticians, nurse practitioners, behavioral psychologist and coordinators experienced with obesity/weight management studies, including dietary counseling. Full-time marketing coordinator and patient recruiter. Excellent recruitment and retention strategies. Site has database of over 2000 with BMI of 30 or greater. Norfolk named one of the top obese cities. According to U.S. Centers for Disease Control, 58% of all Virginians are overweight or obese. Obesity in VA jumped 10% in the last decade – more than any other state. Site has completed one weight loss trial in obeses subjects. Goal 20 subjects randomized, 26 screened, 22 randomized and completed.
AMR Women’s Health Experience
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 757-627-7446 CRAT has conducted oral contraceptives, overactive bladder, stress urinary incontinence, vaginal infections and menopause studies. Board Certified OB/GYN in group practice with clinical research experience.
HSDD and FSD Experience
Duane Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org CRAT has conducted several women’s health studies. Work with large OB/GYN group practice that sees many HSDD and FSD pts. Clinical research coordinators are ACRP certified.
Immune System
Duane G. Wombolt, MD Edie Wombolt 757-627-7446 ewombolt@crat.org Site located in region of 1.6M people with high prevalence to allergies. PI have over 30 years clinical research experience and is an ACRP Certified Principal Investigator. Clinical Research Coordinators are ACRP certified. Site has conducted 23 vaccine studies in varying indications and is very experienced conducting large, rapidly enrolling vaccine clinical trials.
OAB and Urinary Incontinence
Duane G. Wombolt, MD – Board certified Internal Medicine & Nephrology Edie Wombolt 757-627-7446 ewombolt@crat.org Conducted 2 OAB studies, 2 Stress Urinary Incontinence studies and 1 BPH study. Exceeded goals. PI board certified in internal medicine and nephrology, with over 30 year’s clinical research experience. An ACRP Certified Investigator; Clinical Research Coordinators are ACRP certified. Work with large OB/ GYN practice.