Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Endocrinology
Family Medicine
Gastroenterology
Healthy Volunteers
Hematology
Immunology
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Nephrology
Neurology
Ophthalmology
Pediatrics/Neonatology
Pharmacology/Toxicology
Psychiatry/Psychology
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 180available beds, pharmacy and drug storage, an on-site laboratory and state of the art cardiac services. With over 12 years’ experience conducting over 150 Phase I studies, involving more than 3,000 subjects, the experienced staff provides expert delivery of services to safely and efficiently initiateand manage early-phase studies end-to-end – from First-in-Human to proof of concept. This includes all services surrounding volunteer recruitment such as robust and active volunteer database and multi-operator call center; and data collection fully aligned to FDA guidelines --combined with experience in electronic data capture, handling of regulatory approvals, lab coordination contracting and complete communication logistics.

Clinical Research Experience

Clinical Trials Experience

• First in Human
• Maximum Tolerated Dose Studies
• SAD
• MAD
• Food Effects Pharmacokinetics / Pharmacodynamics Studies
• Drug – Drug Interaction (DDI) Studies
• Bioequivalence
• Thorough QTc
• Vaccine

The current pharmacodynamic techniques at our San Antonio unit include:

• Abdominal Sonography
• Capsaicin Challenge
• Exhaled Breath Condensation
• Hypertension
• Induced Sputum
• Metacholine Challenge
• Oximetry
• QT'c-Prolongation
• Skin Prick Allergy Test
• Arrythmias
• Blood Gas Measurements • Exhaled Nitric Oxide Measurement
• Imaging
• Liver MRI
• OGTT
• Spirometry
• Treadmill Challenge
• Exercise Challenge
• Impedance Cardiography
• Pupillometry
• Stress Test

Facility Description

The San Antonio unit is equipped with 110+ beds, arranged in semi-private rooms. The unit has conducted a range of in-house studies with volunteers residing in the unit from one night to 28 overnights. As subject comfort is a priority, the unit is equipped with a variety of recreational services. Each patient room is equipped with cable television and DVD player.

In addition to comfort, the unit is committed to subject safety and security. In the case of emergency, personnel are instructed to call 911 for ambulance/EMT and to call Northeast Baptist Hospital Emergency Room (the hospital is 3.45 miles or approximately 7 minutes from the clinical unit) to notify them of an impending arrival.

Summary:

• 180 Beds (semi-private room)
  • Private Bath Area (making it operationally an ideal setting for long term studies)
  • 10 bed ICU ward (also used for glucose clamping)
  • 4 bed PD room
• 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
• Pulmonary function and exercise stress testing
• Electronic Data Capture (EDC) systems
• On-site pharmacy with Bio hood
• 2 PK laboratories with 12 centrifuges on-site
• Central IRB

Investigator Experience

The San Antonio CPU medical staff consists of 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 CPU 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 and all clinical staff are encouraged to become Advanced Cardiac Life Support (ACLS) certified; Currently ACLS certified employees are staffed on all unit shifts to ensure emergency care coverage 24/7. Additionally all clinical staff members are encouraged to maintain continuing education credits per their licensure and/or registration requirements.

San Antonio employs the following dedicated full-time Investigators:

Dennis A. Ruff, M.D.

• Board Certified, Internal Medicine
• 22+ years in industry research
• Over 400 Phase I-III Clinical Trials Conducted

Emanuel DeNoia, M.D.

• Internal Medicine Board Eligible
• 15+ years in industry research
• Principal Investigator: >300 studies

Laura Sterling, M.D.

• Board Certified, Family Medicine
• 3 years in industry research
• Principal Investigator: >100 studies

Lawrene Tardo, Senior Director

• 17 years clinical research experience
• 6 years project management experience
• Involved in over 300 Phase I/IIa clinical studies

Patient Demographics

Our sites have robust volunteer databases of both healthy volunteers and special populations - and we regularly access other select patient populations through our relationships with local physicians. Recognizing that the foundation for a successful study begins with successful recruitment, all our units have a dedicated team whose sole focus is recruiting and screening, regularly employing ongoing and study-specific media campaigns to enhance our ever-growing network of volunteers.

San Antonio/Houston

• Volunteer database
  • 8000+ Healthy
  • 5000+ Diabetic
  • 100+ Post-Menopausal
  • 350+ Older – age 55+
• Metropolitan population of 2 million in San Antonio + 4 million in Houston
• 15 area colleges/universities
• Multiple Military Bases
• 40% Caucasian non-Hispanic, 40% Hispanic, 15% African American, 5% other

Other Information

Contact Center

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