Asheville Gastroenterology Associates (AGA) is committed to the ethical standards of clinical research based upon sound scientific principles. Our clinical research program offers treatments in a variety of digestive disorders by enrollment in nationally acknowledged clinical trials at the forefront of discovery. Headed by our director, William R. Harlan, III, MD, we have conducted gastroenterology and hepatology clinical trials for more than 16 years. Through our clinics and endoscopy center, we are able to provide many onsite services necessary for clinical trials including:
- On-site Endoscopy Center
- Upper and lower endoscopy procedures (including MAC anesthesia if required)
- Dedicated, private examination rooms
- Fibroscan®
- Esophageal/anal manometry
- pH monitoring
- Lactose, lactulose, and fructose breath tests
- Helicobacter pylori breath tests
- IV Infusion therapy
- PillCam
- BRAVO
- Hemorrhoidal banding
- Local hospital lab on-site for optional/stat lab requests
Research accommodations include
- Blood specimen collection and processing in a dedicated research lab, along with shipping of hazardous substances (all research personnel IATA/DOT certified)
- Dry ice availability
- Refrigerated centrifuge along with varying speed ambient centrifuges, calibrated yearly
- Temperature-monitored biologic sample refrigerators/freezers (4◦C, -30/-70◦C)
- Limited access secure/locked study record and storage space
- 12-lead interpretative ECG
- On-site limited access medical records and secure electronic medical records storage
- Convenient access to outpatient diagnostic services- i.e., liver biopsy, radiology, nuclear medicine and ultrasound through affiliations with local medical facilities
- Digital and analog file transfer capabilities
- Remote and high speed internet with dedicated monitoring area
- Data mining capabilities for accurate feasibility completion/assessments
- Federalwide Assurance for the protection of human subjects (FWA#00010245)
- Conflict of Interest public policy posted on website
Our staff include a dedicated team of research coordinators trained to implement, conduct and manage clinical trials under direct supervision of Digestive Health Partners physicians (DHP). All research staff are trained in ICH-GCP guidelines, along with all federal/local laws and regulations, and Standard Operating Procedures. All research staff, physicians, and mid-level providers maintain CITI certifications every two years.
Research/Administration staff responsibilities include
- Careful pre-trial evaluation/feasibility including ethical considerations for any trial proposal
- Comprehensive contract review and budget evaluation/negotiation/approval process
- Regulatory/IRB document submission and reporting
- Utilization of central IRB’s for expeditious start-up
- Patient recruitment (on-going referral capture)
- Study tracking
- Investigative product storage/tracking/disposal
- Study coordination and case report form completion through various EDC systems
- Experience with use of electronic data reporting and randomization methods
- Participation in analysis and publication of data
Our Clinical Research Manager, Roberta Golden, has extensive experience in clinical research/management:
- ACRP certification (CCRC)
- Bachelors in Business Administration
- 25 years in management
- CRA course completion
In addition to our manager, our clinical research coordinators/regulatory specialists collectively possess:
- Bachelor & Associate degrees
- RN/ LPN degrees
- Certified ACRP staff (CCRC)
- Certified SoCRA staff (CCRP)
- BLS and ACLS certifications
- CPR certified staff