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Raa Presentation  5 24 10 Raa Presentation 5 24 10 Presentation Transcript

  • An Independent Site Network
  • Agenda
    • Introduction
    • Background
    • Locations
    • Site Capabilities & Facilities
    • Clinical Trials Experience
    • Patient Recruitment
    • Q&A
  • Introduction
    • Mary A. Raines Director of Business Development (Houston) Katy, TX Phone: 281-579-1938 Fax: 281-646-8750 [email_address]
    View slide
  • Background
    • Founder and Owner,
    • Board-Certified ENT/Cosmetic Surgeon
    • Origination – Dallas, Texas
      • Research Across America was founded in 1989,
      • originated from Dr. Adelglass’ private practice.
    • Current – 6 Multi-specialty/Regional Locations
    Jeffery Adelglass, MD View slide
  • Background
    • RAA - an independent Site Network (Non-SMO)
    • 6 Multi-specialty/Regional Locations
      • 20 Sites
      • 20+ PIs – 20+ Sub-investigators
      • 16 CRCs
      • 64 Total Employees
      • 45 Currently Enrolling Studies
  • Locations
    • Dallas, TX – Headquarters
        • Plano, TX
        • Carrollton, TX
    • El Paso, TX
    • Houston (Katy), TX
    • New York, NY
    • Reading, PA
        • West Lawn, PA
        • Wyomissing, PA
    • Lancaster, PA
  • Texas - Dallas
    • Regional/Headquarters Office
      • Mr. Kelly Walker, C.O.O.
      • Ms. Smriti Apte, M.S., Director of Clinical Operations
    • Principal Investigators:
    • Dallas, TX ( Dedicated Site)
      • Joe Blumenau, M.D. , Medical Director
        • – Retired Family Practitioner – Full-time Research Physician
      • Jack Seidel, M.D.
        • – Board-Certified Pediatrician
      • Gerald Sigman, M.D.
        • – Board-Certified OB/GYN
      • Ronald Kapusta, M.D.
        • – Board-Certified OB/GYN
      • Barry Sanders, M.D.
        • – Board-Certified Gastroenterologist
  • Texas – Dallas Suburbs
    • Principal Investigators:
    • Plano, Texas
      • Jeffrey Adelglass, M.D.
      • - Founder/Owner
      • - Board-Certified ENT/Cosmetic Surgeon
      • Sejal Mehta, M.D.
      • - Board-Certified Child and Adult Psychiatry
      • - Psychiatric Medical Associates (PMA)
    • Carrollton, Texas
      • Jeffrey G. Stewart, M.D.
      • - Board-Certified Family Practice
      • - Family Medical Associates of Texas (FMAT)
      • Kenneth Goldberg, M.D.
      • - Board-Certified Urology
      • - Texas Urology
  • Texas – El Paso
    • Site Manager:
      • Michael Raucci, CRC
    • Principal Investigators:
      • Gonzalo Diaz, M.D.
        • Board-Certified Pulmonologist, Internist, & Sleep Physician
      • Sergio Ibarra, M.D.
        • – Board-Certified Emergency Medicine -- Urgent Care Facility
  • Texas - Houston (Katy)
    • Site Manager:
      • Marcela Martinez, CRC
    • Principal Investigators:
      • Nancy G. Campbell, M.D., Medical Director
        • - Board-Certified Family Practice/Full Time Research Physician
      • Mark Bing, M.D
        • - Board-Certified Internal Medicine
        • - Medical Colleagues of Texas
      • Padma Chimata, M.D.
        • - Board-Certified Internal Medicine / Rheumatology
        • - Katy Rheumatology & Associates
  • New York – New York City
    • Site Manager:
      • Ms. Jay Kumar, CRC
    • Principal Investigators:
      • Howard Adelglass, M.D.
      • - Board-Certified Physical Medicine & Rehabilitation Medicine
      • - Manhattan Pain Management & Sports Medicine
      • Tim Canty, M.D.
      • - Board-Certified Anesthesiology
      • - Spine and Pain Consultants of New York
      • Howard Grossman, M.D.
      • - Board-Certified Internal Medicine/Infectious Disease-HIV
  • Pennsylvania - Reading
    • Regional Administration Office
    • Site Manager:
      • Ms. Gaye Corbin, CRC
    • Principal Investigators:
    • Reading, PA
      • Alan P. Levine, M.D.
        • - Board-Certified Internal Medicine
        • - Southeastern Berks Internal Medicine Associates
      • Eric Bluestone, D.D.S.
      • - Dentistry
      • David Bluestone, D.D.S.
      • - Dentistry
  • Pennsylvania – Reading Suburbs
    • Principal Investigators:
    • West Lawn, PA
      • Charles T. Givens, M.D.
        • - Board-Certified Family Practice
        • - Southern Berks Family Medicine
      • Michael Sinitsa, M.D.
        • - Board-Certified Family Practice
        • - Southern Berks Family Medicine
    • Wyomissing, PA
      • Moiz M. Carim, M.D.
        • – Board-Certified Ophthalmology, Retina Specialist,
      • Glenn S. Corbin, O.D.
        • – Primary Eye Care and Ocular Disease Management
      • Kerry J. Burrell, O.D.
        • – Primary Eye Care and Ocular Disease Management
      • Heidi L. Sensenig, O.D.
        • – Primary Eye Care and Ocular Disease Management
  • Pennsylvania – Lancaster
    • Principal Investigator:
      • Michael W. Warren, M.D.
        • - Board-Certified Family Practice
        • - Oyster Point Family Health Center
  • Site Capabilities
    • Phase I (limited), Phase II-IV, Post Marketing
    • Central IRB
    • Quick Budget/Contract & Reg Doc turnaround
    • Centralized Patient Recruitment
    • Standardized SOPs
    • HIPAA Compliant
    • Continuous In-house Training
    • On-site Quality Assurance
  • Site Facilities
    • On-site Labs
      • CLIA Certified
      • IATA Certified
      • Phlebotomy stations
      • Centrifuges
    • Spirometry
    • Stadiometer
    • X-ray – offsite / onsite
    • DEXA/BMD
    • ECG & EKG
    • Dedicated study refrigerators
    • -20 C / -70 C degree freezers
    • Dry ice access
    • Double-lock drug storage
      • Temp & Humidity monitored
    • Secure on site/off site document storage
    • Specified study supply areas
    • Monitor work area
      • Wireless high-speed internet, fax, phone, copier
  • Clinical Trials Experience
    • Over 1300 clinical trials in past 25 years in the following areas:
    Pediatrics Family Practice/Internal Medicine Pain Management Endocrinology/Obesity Vaccines Orthopedics Ear, Nose & Throat Urology Ophthalmology/Optometry Dentistry Smoking Cessation Nutraceuticals Dermatology Rx-to-OTC Insomnia/sleep centers Cosmeceuticals Rheumatology Infectious Disease Cardiology Pulmonary Gynecology Anti-infectives Psychiatry/CNS Gastroenterology Allergy/Asthma
  • Study Example No. 1
    • Date : October 2007
    • Study: Influenza Vaccine
            • Phase III, Normal / healthy – 18-49 yrs
    • Statistics
      • Enrollment Period: 5 weeks
      • Recruitment Results:
        • Consented 926
        • Screen failed 24
        • Contracted 308
        • Randomized 902
        • Completed 892
    • CRO: ICON
  • Study Example No. 2
    • Date : January 2010
    • Study: Acute Low Back Pain
            • Phase IV, Acute onset within 10 days, no meds other than heat/cold
    • Statistics ( for each RAA site )
      • Enrollment Period: 2 weeks
      • Recruitment Results:
        • Contracted 20
        • Randomized 20
        • Completed 20
    • RAA Sites
      • El Paso, TX - Sergio Ibarra, M.D.
      • Dallas, TX - Joe Blumenau , M.D.
      • Katy, TX - Nancy Campbell , M.D.
      • NYC - Howard Adelglass , M.D.
  • Study Example No. 3
    • Date : January 13, 2010
    • Study: Rosacea
            • Phase II, Adults 18+
    • Statistics:
      • Enrollment Period: Projected - Dec 2009-Jun 2010.
      • Study Started – Feb & Completed on Apr 22, 2010
      • Recruitment Results:
        • Contracted 20
        • Screened 48
        • Randomized 42
        • Completed 13
        • Ongoing 29
  • Patient Recruitment
    • The RAA Advantage
      • … is the competitive edge Research Across America has in meeting study recruitment goals. It has evolved over many years of successful trials and is the result of having an effective and highly efficient Centralized Patient Recruitment Department.
    • The RAA Advantage is provided at no cost to each sponsor/CRO we work with and has three (3) primary areas of concentration:
      • Patient Recruitment
      • Community Outreach
      • Patient Retention
  • Q & A
  • Thank You!
    • For your future study needs, please contact…
    • Mary A. Raines Director of Business Development (Houston) Katy, TX Phone: 281-579-1938 Fax: 281-646-8750 [email_address]
    Or visit us on the web at www.ResearchAcrossAmerica.com