Research Center Profile:
Cardiology/Vascular Diseases
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 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
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
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
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
San Antonio Clinical Pharmacology Unit IDSinfo@iconplc.com
Division Headquarters IDSinfo@iconplc.com
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.
