OVERVIEW
Broward Research Group is fully equipped for the performance of
pharmaceutical research studies including sleep trials requiring
polysomnography. We currently have an 11 bed facility with
state-of-the-art technology.
MANAGEMENT
David J. Seiden, M.D.
Medical Director
Cecilia
Mendez, M.S., C.C.R.C.
Director of Business Development
FACILITY DESCRIPTION
Three fully equipped
examination rooms
Eleven fully equipped rooms for sleep studies including polysomnography
(digital and paper tracing), multiple sleep
latency testing and maintenance of wakefulness testing
Shower facilities
ECG, EEG, and pulse oximetry recording equipment
On site CLIA waiver laboratory with phlebotomy and on site processing
Centrifuge
Low (-20 degrees Celsius) and ultra-low (-70 degrees Celsius) monitored
refrigeration of biological samples.
Emergency medicine kit, ambu-bag, and are less than one mile from
Memorial West Hospital
Locked and double-locked drug storage room that is temperature/humidity
monitored with limited access.
Our capabilities include:
Experienced certified
clinical research coordinators
Complete standard operating procedures (SOPs) and training programs
Good Clinical Practice training for Investigators and staff
OSHA training for Investigators and staff
Our source documents are paper records
Electronic subject database
Experienced certified clinical research coordinators
Experience with most electronic data capture (EDC) systems and IVRS for
single- or multi-centerclinical trials
Expert psychometricians and raters for cognitive testing
20 registered polysomnographic sleep technicians
Staff IATA certified to handle biological specimens (Dangerous goods,
Biological substances & Dry Ice)
Dedicated monitoring workspaces with access to internet, fax and copier
RESEARCH EXPERIENCE
BRG has conducted Phase II-IV studies including:
Alzheimers
Disease
Anxiety
Cerebral Vascular Disease
Chronic Pain
Common Cold
Depression
Diabetic Neuropathy
Female Sexual Dysfunction
Fibromyalgia
Influenza
Influenza Prevention
Insomnia
Migraines
Narcolepsy
Obesity
Osteoarthritis |
Osteoporosis
Overactive Bladder
Parkinsons Disease
Peripheral Neuropathic Pain
Restless Legs Syndrome
Rheumatoid Arthritis
Shift Worker Sleep Disorder
Sleep Apnea
Smoking Cessation
Peripheral Neuropathic Pain
Restless Legs Syndrome
Rheumatoid Arthritis
Shift Worker Sleep Disorder
Sleep Apnea
Smoking Cessation |
RESEARCH STAFF
6 ACRP-Certified Study
Coordinators
QA Person: Reviews the case books and provides training to the
coordinators and Investigators
Regulatory Person: 5 days to turn in regulatory documents to IRB.
Contracts Person: 5 days to get contract signed
Recruitment Manager: creates ads, places them in the media
INVESTIGATORS
David J. Seiden, M.D.
Medical Director
Board Certified in Neurology and Sleep Medicine
Jose Caso, M.D.
Family Practitioner
Darryl Appleton, M.D.
Board Certified in Psychiatry and Sleep Medicine
Jose Garcia, M.D.
Board Certified in Rheumatology
Jonathan Masel, M.D.
Board Certified in Urology