Phase I trials are the first stage
of testing in human subjects. Normally, a small (20-80) group
of healthy volunteers will be selected. Phase
I trials are designed to assess the safety, tolerability,
pharmacokinetics, and pharmacodynamics of a drug. At Gulf
Coast Research, LLC we believe it takes a special organization
to conduct successful Phase 1 clinical trials. The
organization must have the experience, facilities and
expertise to perform the trial on schedule, within budget and
to the exact clinical specifications of the Sponsor. To
see how Gulf Coast Research, LLC acheives these goals and superior
results select the links below or continue
reading.
Experience | Facility | Personnel | Approach | Project Management | Recruiting
Gulf Coast Research LLC has over eight years of research experience and has conducted
over 250 successful clinical trials involving just about every
medical specialty. Some of the areas in which we have
extensive experience and have excelled in meeting recruitment
goals include:
In January 2006 our Baton Rouge office
moved into a 12,000 square foot state-of-the-art Phase I
research facility. Our
facility comfortably accommodates up to 55 subjects for
extended over night stays. Our bed capacity, dining room area,
experienced staff, and terrific facility layout, allows
subjects to relax and feel comfortable throughout the clinical
trial process. During down time subjects can enjoy high speed
internet access, television, pool, foosball and video games in
our recreation areas. Below are some of the facility amenities
and capabilities GCR possesses.
|
Facility amenities
include: |
Facility capabilities
include: |
|
55 bed unit |
Laminar flow
hood |
|
Private/semi
private rooms |
Refrigerated
centrifuge |
|
Private exam
rooms |
-20ºC
freezer |
|
Licensed
pharmacy |
-70ºC
freezer |
|
Lab processing
room |
-140ºC liquid
nitrogen freezer |
|
Kitchen/Dining
facilities |
ECG
equipment |
|
Recreation
areas |
IV infusion
pumps |
|
Men's dorm
w/showers |
Crash
cart |
|
Women's dorm
w/showers |
Mercury
Sphygmomanometers |
|
In house
laundry |
Calibrated
scales |
|
Security camera
surveillance |
|
|
Card key
access |
|
All
GCR personnel receive training in Good Clinical Practices
(GCP) guidelines, protection of human subjects, IATA
certification for laboratory processing and shipping, and
company SOPs before working on any clinical trial. GCR
investigators are board certified in a wide range of specialty
areas and have extensive experience in research. GCR on
location staff includes physician investigators, pharmacists,
IV nurses, certified coordinators, project managers,
phlebotomists, and managers for regulatory, QA, contracting,
and budgeting.
Over
the past eight years, Gulf Coast Research has refined its
processes and methods to produce the best possible results for
its Sponsors and contracted CROs. We understand that Sponsors
need timely, accurate data to enable them to make decisions
about the safety and efficacy of their compounds. With this in
mind we have developed an effective mix of clinically sound
SOPs and processes that emphasis safety, data quality,
clinical quality, and timeliness of data collection.
GCR utilizes a project
management approach for all Phase I clinical trials. Because of the level
of sophistication required and the complexity of studies that
are in the Phase I stage, detailed project management is a
must. Each Phase I clinical trial is assigned a Project
Manager for the duration of the trial. The Project Manager
will be responsible for coordinating timetables and
communicating milestones and issues with the Sponsor and key
site personnel. The Project Manager will ensure the following:
-
Coordinate the development of achievable
goals and timetables
-
Organization of appropriate resources
-
Timely completion of all phases of the
study
-
Communicate issues and progress to all team
members and Sponsor representatives
A diverse regional population of greater than 1,000,000 enables
GCR to readily access a virtually untapped volunteer base of
healthy and multiple disease state patients to participate in
clinical trials. GCR has access to over 50,000 college students
in the Baton Rouge, Louisiana area to assist in conducting
“Healthy Subject” trials. Through our experience with the
many studies completed at our site we have developed a comprehensive
database of potential subjects which allows us to quickly recruit
subjects for upcoming trials. In certain cases when the subject
requirements are more specialized or when the number of required
subjects is high, GCR will quickly produce effective, quality
television, radio and print ads using preexisting photos and video
with our media partners.
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