For Sponsors - An Overview
The Sealy Institute for Vaccine Sciences (SIVS) Clinical Trials Program is a comprehensive vaccine
clinical trials program, with a large portfolio of both government and
industry-sponsored trials, covering the spectrum from first time in
human Phase I trials through Phase IV post-marketing studies.
University of Texas Medical Branch
Located on the island of
Galveston 50 miles south of Houston, UTMB offers sponsors the
advantages associated with an academic health center, including:
- Electronic medical records
- Clinical laboratory services
- Investigational pharmacy
- Office of Research Subject Protections & IRB
- In-patient and out-patient facilities
With 693,930
outpatient visits, 40,260 ER visits, 25,444 hospital admissions, and
5,381 births (FY 2013) the SIVS Clinical Trials Group has access to
patients with specific disease conditions as well as plenty of healthy
volunteers.
SIVS Clinical Trials Program
Investigators with a particular interest in vaccines
Research nurses/coordinators are CCRP and IATA certified
Experienced in all aspects of clinical trials
Successful recruitment strategies
High retention rates (>95%)
Focus on protocol compliance and data integrity
Meet Good Clinical Practice standards
Our Facilities
Two locations - Galveston and League City
Both sites have a dedicated clinical trial laboratory for study product storage, sample processing and storage
Triage room
Examination rooms
Offices and storage space
Our Volunteers
Good relationships with our volunteers are fundamental to our success
>2,400 volunteers recruited since 2002
Ages range from infants to the elderly
Demographics - approximately 40% Caucasian, 30% Black, 30% Hispanic
Volunteer registry available
Our Sponsors
- Large pharmaceutical companies
- NIAID DMID Vaccine Treatment and Evaluation Unit (Subcontractor)
- NICHD Pediatric Trials Network
- Small biotech companies