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TRANSCRIPT
An Independent Site Network
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AgendaAgenda
IntroductionIntroduction BackgroundBackground LocationsLocations Site Capabilities & FacilitiesSite Capabilities & Facilities Clinical Trials ExperienceClinical Trials Experience Patient RecruitmentPatient Recruitment Q&AQ&A
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IntroductionIntroduction
Mary A. RainesMary A. RainesDirector of Business DevelopmentDirector of Business Development
(Houston) Katy, TX (Houston) Katy, TX Phone: 281-579-1938 Fax: 281-646-8750Phone: 281-579-1938 Fax: 281-646-8750
[email protected]@researchacrossamerica.com
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BackgroundBackground
Founder and Owner, 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 LocationsCurrent – 6 Multi-specialty/Regional Locations
Jeffery Adelglass, MDJeffery Adelglass, MD
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BackgroundBackground
RAA - an independent Site Network (Non-SMO)RAA - an independent Site Network (Non-SMO)
6 Multi-specialty/Regional Locations6 Multi-specialty/Regional Locations 20 Sites20 Sites 20+ PIs – 20+ Sub-investigators20+ PIs – 20+ Sub-investigators 16 CRCs16 CRCs 64 Total Employees64 Total Employees 45 Currently Enrolling Studies45 Currently Enrolling Studies
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LocationsLocations
Dallas, TX – HeadquartersDallas, TX – Headquarters Plano, TXPlano, TX Carrollton, TXCarrollton, TX
El Paso, TXEl Paso, TX Houston (Katy), TXHouston (Katy), TX New York, NYNew York, NY Reading, PAReading, PA
West Lawn, PAWest Lawn, PA Wyomissing, PA
Lancaster, PALancaster, PA
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Texas - DallasTexas - Dallas
Regional/Headquarters OfficeMr. 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 PhysicianJack Seidel, M.D.
– Board-Certified PediatricianGerald Sigman, M.D.
– Board-Certified OB/GYNRonald Kapusta, M.D.
– Board-Certified OB/GYNBarry Sanders, M.D.
– Board-Certified Gastroenterologist
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Texas – Dallas SuburbsTexas – Dallas Suburbs
Principal Investigators:
Plano, TexasJeffrey 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, TexasJeffrey G. Stewart, M.D.
- Board-Certified Family Practice- Family Medical Associates of Texas (FMAT)
Kenneth Goldberg, M.D.- Board-Certified Urology- Texas Urology
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Texas – El PasoTexas – 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
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Texas - 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
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New York – New York CityNew 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
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Pennsylvania - ReadingPennsylvania - Reading
Regional Administration OfficeSite Manager:
Ms. Gaye Corbin, CRC
Principal Investigators:
Reading, PAAlan 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
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Pennsylvania – Reading Suburbs
Principal Investigators:
West Lawn, PACharles 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, PAMoiz M. Carim, M.D.
– Board-Certified Ophthalmology, Retina Specialist, Glenn S. Corbin, O.D.
– Primary Eye Care and Ocular Disease ManagementKerry J. Burrell, O.D.
– Primary Eye Care and Ocular Disease ManagementHeidi L. Sensenig, O.D.
– Primary Eye Care and Ocular Disease Management
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Pennsylvania – Lancaster
Principal Investigator:
Michael W. Warren, M.D.- Board-Certified Family Practice- Oyster Point Family Health Center
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Site CapabilitiesSite Capabilities
Phase I (limited), Phase II-IV, Post MarketingPhase I (limited), Phase II-IV, Post Marketing Central IRBCentral IRB Quick Budget/Contract & Reg Doc turnaroundQuick Budget/Contract & Reg Doc turnaround Centralized Patient RecruitmentCentralized Patient Recruitment Standardized SOPsStandardized SOPs HIPAA CompliantHIPAA Compliant Continuous In-house TrainingContinuous In-house Training On-site Quality AssuranceOn-site Quality Assurance
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Site FacilitiesSite Facilities On-site LabsOn-site Labs
CLIA CertifiedCLIA Certified IATA CertifiedIATA Certified Phlebotomy stationsPhlebotomy stations CentrifugesCentrifuges
SpirometrySpirometry StadiometerStadiometer X-ray – offsite / onsiteX-ray – offsite / onsite DEXA/BMDDEXA/BMD ECG & EKGECG & EKG Dedicated study refrigeratorsDedicated study refrigerators -20 C / -70 C degree freezers-20 C / -70 C degree freezers Dry ice accessDry ice access Double-lock drug storageDouble-lock drug storage
Temp & Humidity monitoredTemp & Humidity monitored Secure on site/off site document storageSecure on site/off site document storage Specified study supply areasSpecified study supply areas Monitor work areaMonitor work area
Wireless high-speed internet, fax, phone, copierWireless high-speed internet, fax, phone, copier
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Clinical Trials ExperienceClinical Trials Experience
Over 1300 clinical trials in past 25 years in the following areas:Over 1300 clinical trials in past 25 years in the following areas:
PediatricsFamily Practice/Internal Medicine
Pain ManagementEndocrinology/Obesity
VaccinesOrthopedicsEar, Nose & Throat
UrologyOphthalmology/OptometryDentistry
Smoking CessationNutraceuticalsDermatology
Rx-to-OTCInsomnia/sleep centersCosmeceuticals
RheumatologyInfectious DiseaseCardiology
PulmonaryGynecologyAnti-infectives
Psychiatry/CNSGastroenterologyAllergy/Asthma
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Study Example No. 1Study Example No. 1
Date :Date : October 2007 October 2007 Study:Study: Influenza VaccineInfluenza Vaccine
Phase III, Normal / healthy – 18-49 yrsPhase III, Normal / healthy – 18-49 yrs
StatisticsStatistics Enrollment Period:Enrollment Period: 5 weeks 5 weeks Recruitment Results:Recruitment Results:
ConsentedConsented 926926 Screen failedScreen failed 24 24 ContractedContracted 308308 RandomizedRandomized 902902 Completed Completed 892892
CRO:CRO: ICONICON
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Study Example No. 2Study Example No. 2
Date :Date : January 2010 January 2010 Study:Study: AcuteAcute Low Back Pain Low Back Pain
Phase IV, Acute onset within 10 days, no meds other than heat/coldPhase IV, Acute onset within 10 days, no meds other than heat/cold
Statistics (Statistics (for each RAA sitefor each RAA site)) Enrollment Period: 2 weeks Enrollment Period: 2 weeks Recruitment Results:Recruitment Results:
ContractedContracted 2020 RandomizedRandomized 2020 Completed Completed 2020
RAA SitesRAA Sites El Paso, TXEl Paso, TX - Sergio Ibarra, M.D.- Sergio Ibarra, M.D. Dallas, TXDallas, TX - Joe Blumenau , M.D.- Joe Blumenau , M.D. Katy, TXKaty, TX - Nancy Campbell , M.D.- Nancy Campbell , M.D. NYCNYC - Howard Adelglass , M.D.- Howard Adelglass , M.D.
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Study Example No. 3Study Example No. 3
Date :Date : January 13, 2010 January 13, 2010 Study:Study: RosaceaRosacea
Phase II, Adults 18+Phase II, Adults 18+
Statistics:Statistics: Enrollment Period: Projected - Dec 2009-Jun 2010. Enrollment Period: Projected - Dec 2009-Jun 2010. Study Started – Feb & Completed on Apr 22, 2010 Study Started – Feb & Completed on Apr 22, 2010 Recruitment Results:Recruitment Results:
ContractedContracted 2020 ScreenedScreened 4848 RandomizedRandomized 4242 Completed Completed 1313 OngoingOngoing 2929
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Patient RecruitmentPatient Recruitment
The The RAA AdvantageRAA Advantage… … is the competitive edge Research is the competitive edge Research
Across America has in meeting Across America has in meeting study recruitment goals. It has study recruitment goals. It has evolved over many years of evolved over many years of successful trials and is the result of successful trials and is the result of having an effective and highly having an effective and highly efficient Centralized Patient efficient Centralized Patient Recruitment Department. Recruitment Department.
The The RAA AdvantageRAA Advantage is provided is provided at at no costno cost to each sponsor/CRO to each sponsor/CRO we work with and has three (3) we work with and has three (3) primary areas of concentration: primary areas of concentration: Patient RecruitmentPatient Recruitment Community OutreachCommunity Outreach Patient Retention Patient Retention
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Q & A
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Thank You!Thank You!
For your future study needs, please contact…For your future study needs, please contact…
Mary A. RainesMary A. RainesDirector of Business DevelopmentDirector of Business Development
(Houston) Katy, TX (Houston) Katy, TX Phone: 281-579-1938 Fax: 281-646-8750Phone: 281-579-1938 Fax: 281-646-8750
[email protected]@researchacrossamerica.com
Or visit us on the web at www.ResearchAcrossAmerica.com