ICON Early Phase Services/CRU

Center Information

Rita Flusche’
Recruitment
ICON Early Phase Services

Lona Sheeran
Site Director
ICON Early Phase Services
210-283-4553

8307 Gault Lane
San Antonio, TX 78209
USA
210-225-5437
1-877-848-7425 (fax)
volunteers.sat@iconplc.com
www.somethingtobeproudof.com

Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Endocrinology
Gastroenterology
Healthy Volunteers
Infections and Infectious Diseases
Internal Medicine
Neurology
Ophthalmology
Pharmacology/Toxicology
Pulmonary/Respiratory Diseases
Rheumatology
Urology
Vaccines

Center Overview

The San Antonio Clinical Research Unit is a customized site capable of meeting today’s requirements for clinical trials including 120 single beds, pharmacy and drug storage, an on-site PK processing laboratory, safety laboratory and a 48-channel Mortara ECG system.  Since 2008 we have conducted more than 400 Phase I studies.  Our experienced staff provides expert delivery of services to safely and efficiently manage early-phase studies from First-in-Human to proof of concept. This includes all services such as an active volunteer database, data collection fully aligned to FDA guidelines, electronic data capture and regulatory approvals. 

Clinical Research Experience

  • Adaptive Design Studies
  • Bioavailability, Bioequivalence
  • Biomarkers, Imaging
  • Biosimilar Studies
  • Dose Escalation (SAD, MAD)
  • Drug/Drug Interaction Studies
  • Ethnic Bridging Studies
  • First-In-Human
  • Food Effect
  • Patient populations including diabetic, obese, elderly, postmenopausal and gastrointestinal disorders
  • Pharmacodynamic Studies
  • Phase I-III Patient Studies
  • Special Population Studies
  • Split/Matched Age Gender
  • Thorough QTc/epQT Studies
  • Tobacco Studies
  • Vaccine Studies

Capabilities

Clinical Capabilities/Techniques

Cardiovascular – Telemetry Mortara Surveyor-48 channels, echocardiography, Holter monitoring

Imaging Techniques – PET imaging, MRI, EEG, ultrasound, DEXA scan, radiographic imaging

Respiratory – peak flow rate, PFTs, full/partial flow loops, methylcholine challenge, spirometry testing

Pain – quantitative sensory testing, cold pain testing

Ophthalmologic Evaluation – static/dynamic pupilometry measurements

Central Nervous System – computerized cognitive test batteries, wide range of validated rating scales, CSF sampling

Other Techniques – arthrocentesis, PICC line placement, skin biopsy

Facility Description

The San Antonio CRU is equipped with 120 single beds arranged in rooms with 3-5 people per room. The unit has conducted a range of in-house studies with volunteers residing in the unit from one night to up to a month.  As subject comfort is a priority, each patient room is equipped with cable television and subject-controlled heating and air conditioning.

In addition to comfort, the unit is committed to subject safety and security.  We staff each shift with ACLS staff and have mock codes throughout the year.  We have 3 crash carts on site.  In the case of emergency, personnel are instructed to call 911 for ambulance/EMT and to call Northeast Baptist Hospital Emergency Room to notify them of an impending arrival. The hospital is 3.45 miles, or approximately 7 minutes, from the CRU.

Summary:

  • 120 Beds
  • Private Bath Area (ideal for long term studies) in each room
  • ICU ward with 10 hospital beds
  • In-house CLIA/COLA certified, clinical laboratory providing hematology, coagulation, platelet aggregation, chemistry, drug testing, urinalysis
  • 48-channel Mortara telemetry, digital multiple/serial central ECGs, continuous 12-lead Holter monitors, core ECG Data Storage - ideal for tQTC studies
  • Electronic source used within the clinic (TrialOne®)
  • On-site pharmacy:
  • 797 compliant room with compounding
  • Schedule 1 eligible (new in 2019)
  • National IV Certification
  • Aseptic preparation
  • 1 PK Processing laboratory with 9 centrifuges on-site and five -70 degree freezers
  • 3 controlled ventilation rooms
  • Local relationships with: Opthalmologist, Gastroenterologist, Pulmonologist, NASH expert
  • Central IRB

Staff Experience

The San Antonio CRU medical staff consists of Physicians, Registered Nurses (RN), Licensed Vocational Nurses (LVN), Paramedics, Medical Assistants (MA), Respiratory Therapists, and Phlebotomists. The medical knowledge and background of individuals plays an important role in the selection of the clinical staff we employ at the unit. The CRU promotes ongoing medical and emergency care continuing education by offering on site Cardiopulmonary Resuscitation (CPR) training by a certified external trainer (as required by CPR guidelines) every two years. All clinical staff members are Basic Life Support (BLS) certified. Currently ACLS certified employees are staffed on all unit shifts to ensure emergency care coverage 24/7.

Every shift at the clinic has licensed staff which could be an RN, LVN or a Paramedic.  Our Physicians make daily rounds and are on site Monday-Friday and weekends as needed.  Physicians are also on call on weekends on a rotational basis.

 

Investigator Experience

San Antonio employs the following dedicated full-time Investigators:

Cassandra C. Key, M.D. - Senior Medical Director

  • University of Texas Health Science Center (San Antonio, TX)
  • Board Certified, Internal Medicine and Geriatric Medicine
  • 15+ years in medical practice in outpatient clinics, nursing homes, and hospitals with various medical directorships
  • Recognized as “Best Of San Antonio Doctors, 2012” by S.A. Scene magazine
  • 3 years in clinical research
  • 60+ Phase I-III studies as Principal Investigator or Sub-Investigator

Dennis A. Ruff, M.D. - Medical Director

  • Albany Medical College Union University (Albany, NY)
  • Board Certified, Internal Medicine
  • Clinical Professor - Dept. of Medicine (UTHSC San Antonio, TX) 1989-2004
  • 25+ years in clinical research
  • 475+ Phase I-III Clinical Trials Conducted

Emanuel DeNoia, M.D. - Medical Director

  • College of Medicine of New Jersey (Newark, NJ)
  • Board Eligible, Internal Medicine
  • 20+ years in clinical research
  • 325+ Phase I-III Clinical Trials Conducted

Demographics

Our site has a volunteer database of both healthy volunteers and special populations. We regularly access other select patient populations through our relationships with local physicians and with direct to consumer advertising. Recognizing that the foundation for a successful study begins with successful recruitment, our unit has a dedicated team whose sole focus is recruiting and screening. We use ongoing and study-specific media campaigns to enhance our growing network of volunteers.

Our subjects are recruited primarily come from the San Antonio, Austin, Houston and Dallas markets.

  • Volunteer database:
  • 31,000+ Healthy
  • 4,500+ Diabetics (Type 1 and Type 2)
  • 1,900+ Postmenopausal Females
  • 7,500 Age 55+
  • San Antonio, TX market:
  • Metropolitan population of 2.5 million
  • 7th largest city in the U.S.
  • 7th largest Hispanic market in the U.S.
  • 31 area colleges/universities
  • 3 Military Bases that form the Joint Base San Antonio (JBSA) area
  • 26% Caucasian, 7% African American, 63% Hispanic, Asian 3%

Other Information

San Antonio Clinical Research Unit/CRU
ICON Early Phase Services
8307 Gault Lane
San Antonio, TX 78209, USA
Office Number: 210-283-4500
Recruitment: 210-225-5437 or 877-848-7425
volunteers.sat@iconplc.com
www.somethingtobeproudof.com

Contact Center

If you are interested in contacting this center to discuss clinical trials, please complete and send the email form below. A representative from the research center will then follow up with you.