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
