About Clinical Trials of Texas, Inc.
Welcome to the Clinical Trials of Texas website! Established in 2001, Clinical Trials of Texas (CTT) is the fastest growing multi-specialty research organization in San Antonio. Our unique business model has proven to produce high quality data for sponsors and contract research organizations (CROs) while creating great opportunities for our staff and investigators. CTT has established an extensive network of experienced, board-certified investigators who are dedicated to excellence in clinical research and understand the importance of involved oversight. As a quality Site Management Organization (SMO), CTT contracts with experienced research physicians who are knowledgeable of the Code of Federal Regulations and Good Clinical Practices and are well accomplished in conducting clinical research protocols while adhering to sponsor goals and timelines.

CTT is capable of conducting Phase I-IV pharmaceutical and device studies in a wide variety of medical disciplines. As an experienced, high quality SMO, CTT ensures compliance with sponsors' protocols and manages all of the regulatory submissions and documentation required by sponsors and institutional review boards. The staff at CTT is regularly trained on all GCP guidelines and FDA regulations. Our QA/QC Coordinator performs frequent study audits to help ensure data quality and assist in preparation for monitoring visits. Most study coordinators are ACRP certified or are working to become certified. Additionally, CTT has a dedicated subject recruitment department that reaches out to the community to find qualified and compliant study volunteers. Having dedicated recruiters helps to ensure that recruitment goals are met and allows coordinators to focus on subject safety, protocol compliance and data entry.

CTT prides itself on being technologically advanced. CTT has developed its own proprietary Clinical Trial Management System (CTMS) that stores all subject records, forecasts protocol specific visit windows and tracks subject study involvement in all studies. CTT has extensive experience with electronic data capture and transmission through any medium required, having extra phone lines dedicated solely to data transmission and broadband internet connection for high-speed web-based data transfer. Speed and precision in all aspects of conducting clinical protocols, from start up to completion, are what makes CTT one of today's leading research centers in South Texas. We welcome the chance to discuss our capabilities with sponsors and CROs and look forward to developing long-term working relationships through many new study opportunities.

Research Facility Description
CTT now has a 15,000 square foot facility dedicated to clinical research. In addition to Phase II-IV protocols, CTT now has a 10-bed Phase I facility for protocols requiring overnight stays. Depending on the study phase and protocol requirements, subject visits are conducted either on site, in hospitals or at one of the investigator sites. Our facility has eight fully equipped exam rooms and a lab complete with ultra low freezers (-80° & -40°), standard and refrigerated centrifuges, and temperature monitored refrigerators on backup power for drug and vaccine storage. Ambient drugs are kept in a climate controlled, access-controlled storage room. Other on site medical equipment includes 12 lead ECG machines, Tanita digital weight scales, a medical-grade programmable treadmill, crash cart, AED, oxygen, Doppler, ABI equipment and multiple draw stations. All medical equipment at CTT is calibrated and/or inspected by an authorized outside vendor on at least an annual basis, and all OSHA standards including biohazard collection and removal are upheld. The following equipment can be found at our investigative sites: Crash cart, bone density imaging scanner, ultrasound/sonogram capabilities, colposcopy, urodynamics, treadmill, cardiac echo, temperature monitored refrigerator and freezers, centrifuges, x-ray capabilities, auditory and visual testing capabilities, spirometry, pulmonary function tests, emergency care and lab drawing stations.

Phase I Facility Details
CTT's phase-I unit has separate sleeping and showering facilities for men and women, a kitchen for dietician prepared meals, a beautiful lounge area and a dining facility. CTT has Phase-I experienced staff who provide outstanding patient care and strict adherence to sponsor protocol requirements. Smaller cohorts of 10 subjects allow for accuracy and close subject observation which helps ensure subject safety and more accurate data for our sponsors. Finally, because CTT works with an extensive network of physicians, CTT is capable of conducting Phase I studies in multiple therapeutic areas.

Phase II-IV Capabilities
CTT has its own 15,000 square foot research facility which includes eight exam rooms, diagnostic equipment, ECG machines, a medical treadmill and more. CTT's lab is fully equipped with locked temperature monitored refrigerators and freezers on backup power for drug and specimen storage (including -80 degree freezer for ultra-low specimen retention), standard and refrigerated centrifuges and multiple draw stations. CTT also provides dedicated monitoring rooms for sponsor representatives which include high-speed internet access, a business center for copying and faxing, and private rooms to view study files. All investigative sites of Clinical Trials of Texas (CTT) are equipped with the essential equipment to conduct trials in their respective areas of expertise. All equipment is properly maintained and calibrated at least annually. Utilizing one of many subcontracted providers, CTT also provides a full range of diagnostic testing such as radiological exams, MRIs, pulmonary function tests, cardiac stress testing, neurological examinations, etc.

CTT has research expertise in the following areas:
Women's Health: Overactive Bladder, Oral Contraception, Weight Loss, Vaginal Atrophy, Osteoporosis, HPV prevention and detection, Female Sexual Dysfunction , Fibrocystic Breast Disease, Anemia (Postpartum and Iron Deficiency), Heavy Uterine Bleeding, Endometriosis, Uterine Fibroids, Hormone Replacement Therapy and more.

Adult Psychiatry: Major Depressive Disorder, Bipolar Disorder I and II, Generalized Anxiety Disorder, Mild Cognitive Impairment, Sexual Dysfunction Related to Psychiatric Medication, Alzheimer's Disease, Adjunct Therapy.

Pain Management/Anesthesiology: Opioid Induced Bowel Dysfunction, Implanted Devices, Migraines, Post Herpetic Neuralgia, Chronic Pain, Low Back Pain, and more.

Internal Medicine: Irritable Bowel Syndrome, Hypertension, Dyslipidemia, Diabetes Mellitus (Type I and II), Vaccines, Erectile Dysfunction, Osteoarthritis, Influenza, Sinusitis, Congestive Heart Failure.

Gastroenterology: GERD, Ulcerative Colitis.

Vascular Medicine: Peripheral Arterial Disease (PAD), Vascular Surgery Protocols and more.

Pediatrics: Pediatric Vaccines, Otitis Externa, Allergic Rhinitis, Asthma.

Dermatology: Rosacea, Vaccines, Devices , Surgical Wound Management Systems.

Other capabilities and areas of interest include: Diverticulitis, Actinic Keratosis, Cosmetics, Smoking Cessation, Premenstrual Dysphoric Disorder.

View Phase II-IV Site Facilities and Investigators

Phase I Research Facility
CTT is proud to announce the grand opening of its new Phase I facility. This 10 beautiful 10 bed unit is designed to provide a full range of capabilities for sponsors as well as excellent care for study volunteers. Included in the Phase I facility are a kitchen for dietician-prepared meals, separate quarters for men and women, separate men's and women's showering facilities, recreational areas and an adjacent lab and phlebotomy area. Semi-private beds allow for diagnostic testing and patient care in the sleep facility. CTT also has Phase I experienced staff and investigators who understand the tight timelines, protocol complexities, and safety precautions involved in the successful completion of Phase I studies. To find out more about CTT's Phase I capabilities, please call Kay Scroggins, RN, CCRC at (210) 949-0122.

To date we have worked with the following sponsors/CROs:

• Eli Lilly & Co., Inc.
• Astra Zeneca
• Bristol-Myers
• PPD
• R.W. Johnson
• Schering-Plough
• Scirex
• Ortho-McNeil
• ZymoGenetics
• Vasogen
• Quintiles
• Pharmaceutical Resource Corporation
• Duramed
• Covance
• Johnson and Johnson
• Wyeth
• Novum Pharmaceuticals
• Sucampo
• 3M
• Boehringer Ingelheim
• Luitpold
• Neurocrine Biosciences
• Proctor & Gamble
• QuatRx
• Repros
• Roche
• Symbio
• Warner Chilcott
• Alcon
• Allergan
• COSMO
• Eisai
• Horizon
• Sanofi Pasteur
• IOMAI
• KCI
• MannKind
• Neuromed
• Cephalon
• ANS
• Takeda

CTT is able to utilize centralized Institutional Review Boards for all research protocols. We have worked with the following:

• Western Institutional Review Board
• Schulman & Associates IRB
• Quorum IRB
• New England IRB
• Copernicus Group IRB
• Methodist IRB (Local)
• Baptist Health System IRB (Local)
• Sterling IRB
• Coast IRB
• Integreview IRB
• Asentral IRB

Kay Scroggins, RN, CCRC
President
Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr.
Suite 700
San Antonio, TX 78229
USA
210-949-0122
210-949-0181 (fax)
ctt@cttexas.com
www.saresearch.com