OmniTrials
11181 Health Park Blvd
Naples, Florida 34110
239-566-1192 http://www.omnitrials.com info@omnitrials.com

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OmniTrials is a private research facility affiliated with the Sleep Disorder Center of SW Florida, established in 1989 by Dr. Martin Cohn and nationally accredited by the American Academy of Sleep Medicine. For the last 10 years; the site has been dedicated to the clinical drug development of new treatments for insomnia and other sleep disorders through participation in pharmaceutical clinical drug trials. As a result of our extensive research experience our center has been established as one of the leaders in the field of clinical research in sleep disorders and has earned a reputation for consistently meeting enrollment goals, maintaining the highest ethical standards, ensuring research subject safety and maintaining accurate and quality data while adhering to study protocols.

MISSION STATEMENT
To contribute to the development of clinical therapies by meeting the highest standards necessary to assure quality and safety in clinical research-upholding the principles of Beneficence.

We pride ourselves in our successful teamwork approach by joining many elements required for excellence in the field of clinical trials - a highly-qualified staff, accurate data, dedication, professionalism, subject safety and the highest ethical standards. OmniTrials specializes in sleep disorders including:

  • Insomnia (both in-patient and out-patient)
    • Acute, Chronic (Sleep-Onset and/or Maintenance)
    • Transient Model
  • Daytime hypersomnolence
  • Circadian Rhythm disorders, including:
    • Delayed Sleep Phase Syndrome
  • Shift Work Disorder
  • Non-restorative sleep
  • Restless Leg Syndrome
  • Periodic Limb Movement Disorder
  • Narcolepsy
  • Obstructive Sleep Apnea

With an experienced staff consisting of an principal investigator, sub-investigator, certified coordinators and registered sleep technicians, our combined research experience totals well over 30 years in the following therapeutic areas:

  • Sleep Disorders
  • Cardiovascular
  • Neurology
  • Endocrinology
  • Obesity
  • Gastroenterology
  • Oncology
  • Gynecology
  • Pulmonary
  • Psychiatric
  • Rheumatology
  • The site and staff have worked with many Sponsors, CROs, IRBs and Laboratories over the years. Some of them include but are not limited to:

    Sponsors

    • Actelion
    • Arena
    • Cephalon
    • GlaxoSmithKline
    • Eli Lilly
    • Evotec
    • MediciNova
    • Merck
    • Neurocrine
    • Novartis
    • Organon
    • Pfizer
    • Pozen
    • Sanofi-Aventis
    • Sepracor
    • Somaxon
    • Takeda
    • Vanda

    CROs

    • INC
    • ICON
    • PPD
    • Quintiles
    • Parexel
    • Synteract

    IRBs

    • Copernicus
    • Schulman
    • Coast
    • WIRB
    • Quorum IRB
    • Chesapeake IRB

    Laboratories

    • Covance
    • Quest
    • Quintiles
    • BARC
    • MDS
    • CRL
    • Medinet

    Martin A. Cohn, MD
    Medical Director
    Principal Investigator
    Dr. Martin Cohn began doing research in the field of sleep during his fellowship training in Intenal Medicine and Pulmonary Disease since the early 1970's. He performed the Phase I studies of all present FDA approved hypnotics to assure respiratory safety. He is author of the definition of "Sleep Apnea" in the World Book Encyclopedia, has published over 25 scientific articles, 4 book chapters, and presented over 40 scientific abstracts.

    Before establishing the Nationally Accredited Sleep Disorders Center of SW Florida, in Naples in 1989, he was Associate Professor of Medicine at the University of Miami, responsible for training physicians in sleep medicine. He has been Chairman of Institutional Review Boards (IRB) at community hospitals over the years.

    As the importance of sleep and the treatment of Insomnia grew over the past 10 years, he has participated as Principal Investigator in over 50 hypnotic drug trials.

    He is Board Certified in Sleep Medicine by both the American Academy of Sleep Medicine as well as the American Board of Medical Specialists. He spends part of his time practicing clinical sleep medicine, treating the entire range of sleep disorders. He enjoys lecturing on sleep issues to health care practitioners and is on the Speakers Bureau of several pharmaceutical companies. He has been a volunteer on the Board of Directors of many organizations, including the American Academy of Sleep Medicine.

    Maria Pardo, ARNP, CCRC- Co-Medical Director
    Sub-Investigator
    Maria Pardo has been involved in clinical research for the past eighteen years, of which the last ten have been specialized in Sleep Disorders. As a Nurse Practitioner she has been able to function in the capacity of both a certified clinical research coordinator and a Sub-Investigator. She has been affiliated with a multi-center, multi-trail site and has been involved with over two hundred clinical trials. Her duties have and currently encompass source document development, staff training, quality assurance and site management. She has been involved with preparation for Audits and FDA Inspections which have warranted extensive review of sources, case report forms and electronic data capture.

    OmniTrials employs highly qualified clinical research coordinators, each with years of experience in pharmaceutical research, and highly trained PSG technicians, Registered Sleep Technicians and Scorers. All study coordinators and PSG technicians are consistently trained on the most recent GCP guidelines and are either certified/registered through ACRP/BRPT or are working towards acquiring certification/registration. Each coordinator applies a hands on approach to all aspects of clinical trials and are experienced in all elements of executing a protocol.

    Bonnie Adorno-Perez, CCRC
    Director of Clinical Research
    Bonnie Adorno-Perez has been involved in clinical research for the past fifteen years as a coordinator, teacher and supervisor. The last ten years have been specialized in Sleep Disorders. As a certified research coordinator she has conducted nearly a hundred studies in a wide range of therapeutic areas and in conjunction with Dr. Martin Cohn, established OmniTrials as an independent research center in 2001.

    Jennifer Gray, BA, CCRC
    Senior Clinical Research Coordinator
    Jennifer Gray has over five years experience in clinical research. She has a Bachelors degree in Psychology and has conducted over 30 studies in Sleep Disorders and CNS as a certified clinical research coordinator.

    Carolyn Davis, CCRC
    Clinical Research Coordinator
    Carolyn Davis has over six years experience in clinical research. She initially began her research experience as a Sleep Technician and later became a full time clinical research coordinator. She has conducted over 30 studies in Sleep Disorders.


    Positive community attitudes towards clinical research helps create a diverse pool from which to recruit patients. The site uses its extensive private practice and research databases along with well received local advertising to recruit quality research candidates that are dedicated to participation. The area in which the site is located includes a wide variety of demographics allowing for a multitude of studies to be recruited. The site also experiences a high success rate in recruiting elderly patients.


    Neurology
    Psychiatry/Psychology
    Pulmonary/Respiratory Diseases

    OmniTrials is a 5,000 square foot handicap accessible facility located directly across from a major hospital and is easily accessible from Interstate 75, Route 41 and Southwest Florida International Airport. The facility includes but is not limited to the following:

    • Eight patient exam rooms
    • Six private bedrooms for overnight sleep studies equipped with full size beds, satellite TV, phone and internet, with state-of-the-art equpiment for sleep studies:
      • Polysomnography (with and without CPAP)
      • Multiple Sleep Latency Test (MSLT)
      • Maintenance of Wakefulness Test (MWT)
    • Comfortable patient waiting area
    • Individual coordinator offices
    • Private monitoring rooms with telephone and high speed internet
    • 24 hour building security
    • Across the street from a community hospital
    • In-house quality assurance staff
    • Networked computers at each staff member's desk with automated daily backup
    • High speed 24 hour fax on a dedicated line
    • Comprehensive telephone system with voicemail and 24/7 response from a staff member
    • High speed network connection for Internet and E-mail access (remote data capture capability applies)
    • CLIA certified laboratory
    • Centrifuges
    • -20 and -70 freezers for lab storage
    • Daily dry ice availability
    • IATA certified staff
    • Breathalyzers
    • Digital vital signs monitors
    • 12 lead electrocardiogram machines
    • Spirometry (Pulmonary Function Testing)
    • Routine equipment calibrations
    • Refrigerated study medication capability
    • Off site storage for long-term storage of study documents
    • Daily Fed Ex, DHL, UPS, Quest pick up
    • HIPPA compliant



    Bonnie Adorno Perez, CCRC
    Director of Clinical Research
    OmniTrials
    11181 Health Park Blvd, Suite 3040
    Naples, FL 34110
    USA
    239-566-1192
    239-245-1255 (fax)
    info@omnitrials.com
    www.omnitrials.com


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