Clinical Research Unit


San Antonio, TX, USA

The San Antonio Clinical Research Unit is a customized site capable of meeting the ever changing requirements for clinical trials.  The site’s facilities include 180 available beds, pharmacy and drug storage, an on-site PK laboratory, clinical laboratory and a 48-channel Mortara ECG system.  Since 2008 the site has conducted more than 360 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 Trials Experience includes: 

  • First in Human
  • Maximum Tolerated Dose Studies
  • SAD
  • MAD
  • Food Effects Pharmacokinetics / Pharmacodynamics Studies
  • Drug – Drug Interaction (DDI) Studies
  • Bioequivalence
  • Thorough QTc
  • Vaccine
  • Patient populations including diabetic, obese, elderly, postmenopausal, NASH and gastrointestinal disorders
  • Adaptive design
  • Device Studies
  • Biosimilars
     

The  180 single beds are  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 32 overnights. 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.  The staff is prepared for emergency situations and have access to a hospital that is 3.45 miles, from the CRU.

  • 180 Single 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 
  • Pulmonary function 
  • Electronic Data Capture (EDC) systems 
  • On-site pharmacy:
    • National IV Certification 
    • Bio hood
  • 2 PK processing laboratories with 12 centrifuges on-site and four -70 degree freezers 
  • Central IRB
  • Electronic Data Capture (EDC) systems 

TrialOne (T1) is our eSource and Phase 1 site automation solution to support our Volunteer Database, Recruitment, and real-time study data collection.   TrialOne is an FDA 21 Part 11 compliant web-based application that is tablet compatible.  ICON has validated the application for 21 CFR part 11 compliance and for business requirements and purpose.

 T1 provides an advanced electronic platform for our clinical operations.  The web-based interface allows for real-time review and access to data (internally and externally), quicker decision making, reporting functionality and on-demand data export capabilities supporting the latest CDISC standards.  We are implementing T1 in phases.

The ICON CRU volunteer database contains both healthy volunteers and special populations. 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, 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.

John Connell on Two Decades of Clinical Models at ICON

Contact information:
ICON Early Phase Services CRU
Main number: 210-283-4500
Recruitment: 210-225-5437 or 877-848-7425
Recruitment website: www.somethingtobeproudof.com