elite research network 2011
DESCRIPTION
TRANSCRIPT
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Elite Research Network - Overview
Chris Hoyle, MBA
Executive Director
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At a Glance• 28 Investigative Sites (United States)• 2 Investigative Sites (Latin America)• 187 Total Investigators• 220 Total Coordinators• ~450,000+ patients in database• Patient population: pediatrics,
adolescent, healthy adult, elderly.
Summary
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Independently owned sites which share the following criteria:
• Multi-specialty site.• Ability to use central IRB.• Dedicated regulatory specialist at
each site.• Start up regulatory documents
completed within five days or less.
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Independently owned sites which share the following criteria:
• Patient recruiters at each site. • QA program in place at each site.• Contract / budget specialists.• EDC Capabilities.• Emphasis on Investigator and Coordinator
Training.
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Site InfrastructureMedical DirectorMedical Director
InvestigatorsInvestigators
Study Study
CoordinatorsCoordinators
Patient Patient
RecruitersRecruiters
Site DirectorSite Director
Budgets / Budgets /
Contract SpecialistContract Specialist
RegulatoryRegulatory
Specialist Specialist
QA QA
SpecialistSpecialist
Support Staff (Lab Personnel, Research Assistants, Receptionist)Support Staff (Lab Personnel, Research Assistants, Receptionist)
EDC EDC
SpecialistSpecialist
BusinessBusiness
DevelopmentDevelopment
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Therapeutic Capabilities
• Allergy• Cardiology• Dermatology• Endocrinology• Gastroenterology• Infectious Disease• Internal Medicine• Metabolic
Disorders• Musculoskeletal• Neurology
• Oncology (1 site)• Ophthalmology• Pain• Pediatrics• Psychiatry• Respiratory• Rheumatology• Urology /
Nephrology• Vaccines• Women’s Health
Therapeutic Capabilities
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Phase I UnitsAdvanced Clinical Research Institute
(Anaheim, CA)
Avail Clinical Research (DeLand, FL)
Miami Research Associates (Miami, FL)
Clinical Research Atlanta (Atlanta, GA)
Types of Phase I Studies
• First in Human• BA/BE• Drug
Interaction• Food Effect• Age / Gender
Effect
• PK/PD• TQT Studies• PFT Studies• Microdosing• SAD/MAD
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Central Services Offered
Sites: • Business Development• Annual Meeting
Sponsors and CROs: • Feasibility• Site Identification• Study Start up
Geographic Locations
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Feasibility Process (site level)
• Review synopsis (full protocol is better)
• Determine number of eligible subjects in computerized database who fit I/E.
• Experience, Experience, Experience!
• All done within 48 hours or less.
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Factors to consider when reviewing a
protocol / predicting enrollment rates: • Competing studies
• Budget• Start Date
• Time of year • Enrollment goal
• Previous experience • Procedures
• Patient Stipend• Advertising Budget?
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Patient RecruitersPatient Recruiters
INVESTIGATOR SITEINVESTIGATOR SITE - -
TVTV RadioRadio
Existing Existing DatabaseDatabase
Patient Patient ReferralsReferrals
Physician Physician Referrals Referrals
NewsletteNewslettersrs
NewspapeNewspaperr
InternetInternet
Principal Principal InvestigatorInvestigator
Study CoordinatorStudy Coordinator
Patient Recruitment
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“Partner” Enrollment Metrics (Major CRO)
• ERN sites enrolled 216% compared to all other sites.
• 53 studies in different indications.
• ERN is # 1 enrolling “partner” with this particular CRO.
• Established “Partner” status with other sponsors and CROs.
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Retention• Early patient education at screening
visit• Daily investigators involvement /
patient interaction• Flexible hours• Caring and supportive staff• Comfortable office environment• Pay after each completed visit• Appointment reminder calls / cards
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Experience
• Over the last 4 years our network of sites has conducted over 4000 studies.
• Average 1000 studies per year.
• Average ~4 studies per year per coordinator
• Spreadsheet of studies per indication available.
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Conferences
Summit for Clinical Ops Executives (SCOPE): February 7 - 9, 2011. Miami, FL.
Partnerships in Clinical Trials: March 30 - April 1, 2011. Phoenix, AZ.
World Vaccine Congress: April 11-14, 2011. Washington, DC.
ACRP: April 30 - May 3, 2011. Seattle, WA.
DIA: June 19-23, 2011. Chicago, IL.
Site Solutions Summit: October 14-16, 2011. Palm Beach Gardens, FL.
