Excellence in Clinical Research
Clinical Research Experience: Since 2009, Huron Gastro has participated in 53 interventional and non-interventional clinical research studies. We have experience with Phase 2, 3, and 4 studies. As a preferred partner for many clinical research organizations, we consistently work in a collaborative and productive way to ensure a high-quality, research experience.
Recruitment: Our clinical research site was a top recruiting site in the United States for the last two Phase 3 studies we participated in. Our recruitment success is driven first and foremost by a coordinated effort between our providers and our research and information technology departments. Through our databases, we can perform customized searches that allow us to quickly identify potential study subjects and meet all enrollment goals. Once patients are enrolled, we pride ourselves on clear communication to them about the expectations and logistics of the clinical research experience.
Facilities and Resources: Huron Gastro is a private gastroenterology practice on the campus of a large community teaching hospital, Trinity Health St. Joseph Mercy Ann Arbor. In addition to our own on-site endoscopy suites and infusion rooms, we leverage our proximity to the hospital for convenient access to a variety of state-of-the-art equipment and services that is available through the hospital’s clinical research infrastructure. This includes phlebotomy, specimen processing for shipping (IATA certified staff), -20/-70 specimen freezers, local laboratory tests, pathology, radiology, EKGs, and research pharmacy services. The hospital’s research pharmacy, staffed by personnel with Doctor of Pharmacy degrees (Pharm.D.), provides reliable 24/7 IP receipt and accounting, IP dispensing and compounding, and IP ambient/refrigerated drug storage. Additionally, for the convenience of our monitors, Huron Gastro has a designated monitoring area with internet/Wi-Fi capacity and a dedicated laptop computer with access to our electronic health record.
Research Investigators and Staff: Our research team has Human Subjects and GCP certifications and is approved by the Trinity Health Ann Arbor Hospital IRB #1 to participate in human subject research. Our team of nine gastroenterologists, one hepatologist, one physician assistant, four research coordinators are dedicated to providing sponsors with reliable and clean data while making patient safety our highest priority.
IRB: Huron Gastro is required to use Trinity Health Ann Arbor Hospital's IRB. It meets monthly, with submission deadlines occurring two weeks prior. Turnaround time for approval is usually less than two days.
Ongoing Trials: Active Clinical Trials
Previous Trials: List of Trials
For additional information about our site, please contact our research department or our Principle Investigator:
Najm M. Soofi, M.D.
Director of Research - IBD Studies
Phone: (734) 434-6262
Michael R. Fine, M.D.
Director of Research - Liver Studies
Phone: (734) 434-6262