CT Select Site Network

The Site Network

Solution

Corporate Snapshot

•Founded in 1999

•Headquarters located in Raleigh, NC

•Privately owned

•Initial business silo; Software solutions for physician practices

•Primary business silo; CT Select Site Network, launched in 2006

•Metrics - 75 Employees- 339 US Investigators - 60 Netherlands Investigators

CORPORATE STRUCTURE:

• Pete Bechtel, CEO – 25 years experience

• Gray Kirby, PharmD, VP Clinical Research – 25 years experience

• Marty Frazier, Director of Business Development – 30 years experience

• Richard Sanderson, Director of Clinical Services – 25 years experience

• Experienced, Full-Time Clinical Research Coordinators and Managers

• Dedicated Data Integration Team

Common Site Challenges:

A. Selecting Qualified Sites

B. Identifying Appropriate Patients

C. Slow or Non-enrolling Sites

D. Patient Retention

E. Meeting Enrollment Timelines

CT Select Solutions:

A. Qualified sites with Pre-Selected Patients

B. Rapid Start-Up (within 30 Days)

C. Immediate Enrollment

D. Achieving your enrollment timeline

E. Controlling your trial budget

Qualified Sites with Pre-Selected Patients:

Clinical Data Repository (CDR) *HIPAA Compliant Electronic Medical Records Practice Management System Lab Data Medication Data Personal Health Information

Pre-selection based on protocol criteria Primary indication (ICD-9, CPT code) Age, Gender, Special Populations Medication criteria Lab criteria

CDR Process Flow

•EMR

•PMS

•Lab

•Medications

•SmartForms

QueryProtocolSpecificPatientCriteria

eCast CDR

CT Select Investigator

Identified

Rapid Start-up:

A. Site Identification Utilizing our proprietary CDR to identify qualified sites

with pre-selected patients

B. Centralized Process – all sites use: Central IRBs Reg Doc Collection Contracting & Budgeting

Controlling your Trial Budget

A. Central budgeting for CT Select sites All costs are included in the site budget

B. Enrollment without costly Recruitment Programs Most trials can enroll from PIs existing patients Pre-Identified patients from the CDR Predictable enrollment eliminates budget overruns

Community-based Therapeutic Coverage:

Internal Medicine Family PracticePediatrics OB/GYNCardiology EndocrinologyGeriatrics NeurologyUrology Allergy/ImmunologyOtolaryngology OphthalmologyDermatology Emergency MedicineLong Term Care

CT select™ Network Locations

Current: Miami, Ft. Lauderdale, FL

Atlanta, Athens, GA

Charleston, SC

Fayetteville, Raleigh, Wilmington, NC

Baltimore, Laurel, MD

Philadelphia, PA

Northern, NJ

Whiteplains, Brooklyn, NY

St. Louis, MO

Charleston, WV

Netherlands

CT select™ Network Locations

Future: Chicago, IL

Cleveland, OH

Houston, Dallas, TX

Phoenix, AZ

Los Angeles, San Francisco, CA

Seattle, WA

France

Germany

Belgium

UK

Asia

Utilizing the CT Select™ Network1. Patient criteria determined by the protocol

2. Query the CDR to pre-identify sites & patients within the CT Select Network

3. Review the protocol with the investigator for interest

4. Present sites to the sponsor for evaluation

5. Approved sites utilize the CT Select infrastructure: Central IRBs & Reg Doc Collection Budget & Contract Negotiation eCast Regional CRC Network

6. Rapid initiation of sites (4 weeks or less)

7. Patient enrollment begins…

CT Select™ Commitment

Community-Based Investigators with CRCs

Multiple Therapeutic Specialties

US & EU Sites

1,500,000 Unique Patient Records

Rapid Start-up

Reduce or Eliminate Patient Recruitment Programs and Associated Budgets

Questions&

Next Steps

Contact: Laura Bridgman, [email protected]

910.599.1474