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Research Center Profile:
Alamo Medical Research

Center Information

Michael R. France, MPAS, PA-C
Research Director, Phase 1
Alamo Medical Research
621 Camden St., Suite 202
San Antonio, TX 78215
USA
210-253-3426
210-477-1808 (fax)
mfrance@alamomedicalresearch.com
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Contact Center

Therapeutic Areas

Healthy Volunteers
Hepatology (Liver, Pancreatic, Gall Bladder)
Immunology
Internal Medicine

Center Overview

Alamo Medical Research (AMR), is an organization dedicated to clinical research. Our center is modern and well equipped with an expanded Phase 1 unit. We are knowledgeable, experienced, organized, efficient and very motivated. We utilize Central IRBs for rapid approvals. We routinely get projects started, enrolling and subject's treatment initiated months before university-based researchers. We have met all enrollment targets and are frequently the leading enroller for multi-centered trials. We have a fully qualified and experienced professional, research and support staff. Our mission focus is on delivering the highest quality of products and services to our sponsors and facilitating access to the latest and most innovative clinical trials to our community. AMR is co-located and associated with the Liver Institute of South Texas (LIST) a one stop center for the care of patients with liver diseases in San Antonio and South Texas and Digestive Diseases Center of South Texas, a multi-physician gastroenterology practice which provides a steady source of potential subjects. AMR is also co-located and associated with the GAB Endoscopy Center which facilitates ready access for endoscopic services and Camden Laboratories, our new clinical-pathological and molecular laboratory that enables the center to run in-house routine and complex testing to rapidly quantify viral infections, such as HCV RNA, HBV DNA and make timely decisions for the benefit of our patients. AMR is a respected referral center and community resource for the latest clinical trials in Chronic Hepatitis C and other related diseases.

Performance Metrics

Number of Studies Conducted: 457
Number of Studies Actually Completed: 346
Number of Active Patients in the Database: 1200
Regulatory Submission Turn-Around Time: 5 Business Day(s)
Average Number of Total Patients Enrolled: 30
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 99%
EDC Capabilities: Yes

Clinical Research Experience

AMR specializes in Phase I-III hepatic and renal intolerance, hepatitis C, hepatology disease states, PK, PD as well as healthy volunteer trials. Given our ability to be high enrollers, we have had many sponsor targeted audits and have consistently received complementary reviews.

Sponsors we have worked with include:

  • Schering-Plough Research Institute
  • Pharmasset
  • Santaris Pharma
  • Scynexis
  • Novartis Pharmaceuticals Corp
  • Intermune Inc.
  • Idenix Pharmaceuticals
  • Vertex Pharmaceuticals
  • Tibotec
  • Zymogenetics
  • Akros Laboratories
  • Anadys Pharmaceuticals Inc.
  • Guilford Laboratories
  • Coley Pharmaceutical Group
  • Glaxo Smith Kline Group
  • TAP Pharmaceuticals
  • MGI Pharma
  • Roche Laboratories
  • Bristol-Myers Squibb
  • Valeant Pharmaceuticals
  • Gilead Sciences, Inc.
  • Achillion Pharmaceuticals
  • Intarcia Therapeutics
  • Merck & Co.
  • Medarex
  • Echosense
  • Otsuka
  • Pfizer
  • Presidio
  • Peregrin
  • Salix
  • Sanofi-Aventis
  • Sucampo
  • ZS Pharma
  • ColoTech
  • Biolex
  • BoehringerIngelheim
  • GlobeImmune
  • Hollister
  • Idera
  • Johnson & Johnson
  • Eli Lilly
  • Medtronic
Millenium

We have worked with a number of CROs such as:

  • PPD (Pharmaceutical Product Development)
  • CSMG, Inc (Clinical Studies Management Group)
  • Quintiles
  • PharmaNet
  • Covance.

Facility Description

AMR occupies a newly expanded Phase 1 unit with 24 beds, within the Camden Medical Center, designed and built specifically to conduct clinical research with good clinical practices in mind. AMR is conveniently located in central San Antonio, Texas, within two blocks and easy access to major highways (Interstates10, 35, and 37), 15 minutes from San Antonio Airport and parking is free. AMR is located within 0.25 miles of two major hospitals.

AMR includes limited access areas for Phase 1, Research Administration, Research Records, Pharmacy and Laboratory.

Our Laboratory contains:

  • -20° freezer and a -70° freezer that is locked and has automatic temperature monitoring with alarm
  • Separate blood drawing /processing area
  • Locked storage
  • Both ambient and refrigerated centrifuges, Vortex machine, Orbital shaker, and a Puritan-Bennett Portable Spirometer Unit

Our Pharmacy contains:

  • Locked and temperature monitored medication refrigerators.
  • Both open shelf and locked storage.
  • Both the laboratory and pharmacy have emergency generator backup to prevent power interruption.

Phase 1 and Outpatient Units

  • 24 bed phase 1 unit with dietician supervised meals, available 24/7
  • We have a fully equipped treatment room for liver biopsies, EKG, IV infusion and other procedures.
  • Onsite emergency equipment; oxygen, defibrillator, suction, stat kit 900.
  • Centralized nurses’ station
  • The entire clinic has a remotely monitored security system.
  • The clinic is fully equipped with the latest computer equipment with high speed internet access for communications which allows us to use electronic CRFs and data management.
  • Dedicated and experienced phase 1 staff familiar with serial pharmacokinetic and pharmacodynamic studies.
  • Our research team is adept at collecting, processing and shipping serial PK/PD samples

Investigator Experience

Dr. Eric J. Lawitz is board certified in Gastroenterology and Internal Medicine and is the Medical Director and principal investigator for AMR. Dr. Lawitz has been conducting clinical trials since 1995, has conducted extensive research in Chronic Hepatitis C and is a Certified Physician Investigator. He has been both an investigator and sponsor/investigator. Dr. Lawitz has extensive experience in Internal Medicine and Gastroenterology.

Dr. Fred Poordad is board certified in Gastroenterology and Transplant Hepatology. He came to us from Cedars Sinai Medical Center in Los Angeles, California. While at Cedars Sinai, he was the acting Chief of Hepatology and Liver Transplantation. He was also a Clinical Professor of Medicine at David Geffen School of Medicine at UCLA. Dr. Poordad has over 15 years of experience with research and treatment of hepatological diseases.

Dr. Fernando Membreno is board certified in Gastroenterology, Transplant Hepatology and Internal Medicine. He joined the institute and brought in his experience in the management of liver failure, liver transplantation and liver cancer.

Dr. K.P. Ganeshappa is board certified in Gastroenterology and Internal Medicine and is a sub-investigator. Dr. Ganeshappa has extensive experience in Gastroenterology since 1971. He has extensive experience conducting numerous clinical trials investigating GERD, and has participated in Chronic Hepatitis C clinical trials since 2000.

Dr. Hector D. Allende is board certified in Gastroenterology and Internal Medicine and is a sub- investigator. Dr. Allende has extensive experience in Gastroenterology and has been participating in clinical trials, with emphasis in IBS and GERD, since 1981.

Dr. Ravi Botla is board certified in Gastroenterology and Internal Medicine and is a sub- investigator. Dr. Botla has extensive experience in Gastroenterology and has been participating in clinical trials, with emphasis in liver disease, since 1995.

Dr. Ravi Ganeshappa is board certified in Gastroenterology and Internal Medicine and is a sub-investigator. Dr. Ganeshappa has been participating in clinical trials, with emphasis in Barrett's Esophagus, since 1989.

PA. Michael R. France, MPAS has experience as a clinical research sub-investigator, with emphasis in Chronic Hepatitis C, since 2000, and is a Certified Clinical Research Coordinator. He has over 22 years of experience in Family and Emergency Medicine and Otorhinolaryngology.

All investigators are trained and experienced in all facets of clinical research to include: Good Clinical Practices, Investigator Responsibilities, Documentation, Reporting of AEs and SAEs, working with IRBs and CRFs.

Staff Expertise

AMR has an expert staff comprised of our Research Director, Contracts and Finance Manager, Operations Managers, Start Up Specialist, Source Document Specialists, Recruiters, Certified Clinical Research Coordinators, MA, phlebotomists and pharmacy technicians. All required staff are IATA certified for shipping hazardous materials.

Patient Demographics

Our referral base includes the entire south central Texas region. The south Texas region has many patients with Chronic Hepatitis C and liver disease. San Antonio has a population of 1.5 million, 50% Hispanic and the community has a very positive attitude towards research. Both treatment naive patients and relapser/nonresponder patients are represented. Referral patterns include self-referrals from our radio, print and TV advertising but mostly from our Primary Care practices and Gastroenterology practices. Many referrals occur in response to lecturing done by AMR professional staff to individual practices, professional organizations and medical conferences throughout the area. Additionally, we have five Board Certified Gastroenterologists at the Camden Medical Center who refer patients for clinical trials. We have had no difficulty identifying sufficient subjects for any hepatic/renal impaired or hepatology disease that needs to be obtained.

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.

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