The Gastroenterology and Hepatology Clinical Research Program provides efficient, comprehensive, and cost-effective research support and services, prioritizing the care and protection of human subjects, and offers a successful model for conducting and managing clinical trials dedicated to developing new therapies through clinical research.

Our Mission

To provide the most efficient, comprehensive, and cost effective research support and services. Remain at the forefront of scientific knowledge and development while holding the care and protection of human subjects in the highest regard.

Efficient: Streamline the research process and continuously assess the process to improve the output.

Comprehensive: Provide regulatory, financial and coordination support for trials. Provide education and training for participants, research staff and investigators.

Cost effective: Provide services and support at the highest level of accuracy for the best price. Maintain a working knowledge of income expenses and overheard.

Knowledge: maintain and expand our knowledge of research and the disease processes we study through education, awareness and outreach.

Development: Add to the scientific knowledge throughout research work. Build relationships and partnerships with patients, community, and research environment.

Care: provide the best possible care to our participants. Act as an advocate for their healthcare.

Protection: Safeguard the rights of patients and research participants. Know and follow the ethical and federal guidelines that protect participants.

Our Services

We effectively manage research studies from start to finish. We can provide study, regulatory, and financial management for clinical research projects.

We are a large referral base for physicians in the southeast, with referrals MS, GA, LA, TN, FL, SC, and VA. This provides a solid recruitment base for potential subjects interested clinical trials.

• Regulatory Management
• Organization and maintenance of study records
• Initial Submissions & Renewals
• Study feasibility assessments
• Develop recruitment plans
• Strategic planning
• Quality Assurance

Our Research Experience

• Conducted over 75 clinical studies in the last 5 years including Phase I, II, III, IV clinical trials.
• Experienced with investigator initiated, complex, & multi-center studies.
• Remote data entry experience
• IVRS/IWRS
• Skilled at negotiating budgets utilizing UAB’s Fiscal Approval Process (FAP) and SiteMinder.

Our Facilities

• Comprehensive diagnostic laboratory including sample storage: long and short term -20C & -70C
• Dedicated Research Pharmacy: locked and temperature controlled
• GCRC: PK sampling and overnight stays (8 private rooms)
• GI/Hepatology Out patient clinic: 7 exam rooms
• Space dedicated for monitors with internet access
• Inpatient: 5 hospital beds

Our Research Interests

We have several research projects in basic science and clinical research. Our research interests include, but are not limited to the following:

• Pancreatitis
• Immunology and inflammatory bowel disease
• Acute and chronic liver disease
• Hepatitis C
• Hepatitis B
• Hepatic Encephalopathy
• Liver transplantation
• Steatohepatitis

Sponsor Resources

We offer valuable information for industry sponsors, including details on subject recruitment, site information, and IRB details.

General Information about UAB

We are affiliated with all UAB clinics and facilities. This allows us to participate in protocols that require multiple disciplines. For outpatient studies we use & list the Kirklin Clinic as our site for subject visits & evaluations. For Inpatient studies, we use the main UAB Hospital as our site, regardless of the subject’s exact location (i.e.:  West Pavilion, North Pavilion, etc...)

Due to the overlapping of UAB’s Institutional Research & Healthcare facilities, there are often different names and addresses for the same location & different addresses based on physical location, mailing or courier service. Please refer to the addresses below for exact location. It is not our policy to alter CVs for individual studies; however, we will be as accommodating as possible.

We can also utilize the UAB PCIR for PK studies and patient visits and the UAB Outreach Research Lab to process samples.

Subject Recruitment & GI/Hepatology Clinic
Located in the Kirklin Clinic there are over 10,000 (GI/Hepatology related) patients seen each year. Specifically there are 640 new and 2930 returning Hepatitis C patients each year. The clinic also offers 15 referring physicians. This provides a solid recruitment base for clinical trials.

Institutional Review Boards (IRB)

Per UAB requirements, we use a Local IRB for all research studies. For industry sponsored studies, The Western Institutional Review Board (WIRB) is designated as a local IRB. WIRB meets daily and enables us to have flexible submission dates, which in turn allows for faster start up.

For Investigator Initiated studies we use the UAB IRB, which meets weekly. Again, this allows us to have relatively flexible submission dates.

IRB Approval Time
We estimate that it will take approximately 4 weeks to receive approval once the submission is received by either review Board.

Locations & Address: