Research Site Profile

Research Site Introduction:

The San Antonio Clinical Research Unit is a customized site capable of meeting today’s requirements for clinical trials including 110 available 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 can provide all of the necessary services to start and manage single and multiple studies. This includes all services surrounding volunteer recruitment such as a 8,915+ active volunteer database and multi-operator call center; and data collection meeting or exceeding FDA guidelines combined with experience in electronic data capture, handling of regulatory approvals, lab coordination contracting and communication logistics.

Research Site 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:

• 110 Beds (semi-private that can expand to 4 beds per room)
• Private Bath Area (making it operationally an ideal setting for long term studies)
• 6 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
• 32-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
• On-site PK processing laboratory
• Central IRB

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
• 3000+ Diabetic
• 100+ Post-Menopausal
• 350+ Older – age 55+
• Metropolitan Population of 2 Million in San Antonio and 4 million in Houston
• 15 area colleges/universities
• Multiple Military Bases
• 40% Caucasian non-Hispanic, 40% Hispanic, 15% African American, 5% other

Additional Information:

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 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.