elite research network 2011

2

Elite Research Network - Overview

Chris Hoyle, MBA

Executive Director

3

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

4

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.

5

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.

6

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

7

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

9

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

11

Central Services Offered

Sites: • Business Development• Annual Meeting

Sponsors and CROs: • Feasibility• Site Identification• Study Start up

Geographic Locations

13

14

15

16

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.

17

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?

18

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

19

“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.

20

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

21

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.

22

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. 

23

Contact Information:

Chris HoyleE: choyle@eliteresearchnetwork.com

P: 843-849-7382

Thank you!