Since 2008, the Division of Research at Digestive Health Associates of Texas (DHAT), led by our Primary Investigator, Dr. Kenneth Brown, has been engaged in clinical research involving therapy for IBD, IBS, and anesthesia. Other areas of interest are Gastroesophageal Reflux Disease (GERD), Peptic Ulcer, Celiac Disease, Constipation, Diarrhea and Biliary Tract and Pancreatic Diseases.
We provide clinical trial services to Sponsors and Clinical Research Organizations (CROs) facilitating clinical research trials. We are part of Digestive Health Associates of Texas which employs over 80 Board Certified Gastroenterologists. With access to our patient data base, we are able to quickly and efficiently power studies.
Research Facilities and Capabilities
The Division of Research at Digestive Health Associates of Texas is under the leadership of Kenneth, J. Brown, MD as Principal Investigator. Matthew Eidem, MD., Sindhu Abraham, MD., Markus Goldschmeidt, MD., and Michael Weisberg, MD., support the studies conducted at DHAT as Sub-Investigators. Coordination and study implementation is provided by Brandi Scott, MA, CCRC who has years of experience developing, coordinating and conducting research.
- Subject Recruitment-The staff at DHAT has been successful in recruiting subjects to GI studies.
- Compliance with FDA and International Committee on Harmonization (ICH) Policies and Regulations Concerning Clinical Trials -DHAT has been conducting clinical trials in support of pharmaceutical company sponsored New Drug Applications. The group at DHAT is experienced with the policies and regulations governing the conduct of clinical trials and continues to adhere to the Good Clinical Practice Guidelines (http://www.fda.gov/cder/guidance/959fnl.pdf ) as set forth by the FDA. All key research personnel have completed the human subjects’ protection certification course. Further, all new studies are in compliance with the new Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule) as required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
- Extensive experience in working with an off-site data management center, including providing hard copy and electronic clinical research data accurately and in a timely manner.
- Digestive Health Associates Research Division makes it a point of processing all paper work in a timely manner with minimal turn-over time.
Our experience and unique patient population allows us great opportunities in facilitating clinical research. We have participated in multiple studies including; Crohn’s Disease, Ulcerative Colitis, Ulcerative Proctitis, as well as IBS and anesthesia. In all of the studies we have participated in, we have been one of the leading enrollers, including the IBS study in which we were the top enroller in the nation.
DHAT has complied with delivery and performance schedules on all contracts, and has consistently delivered quality products and services. DHAT has never had any contracts terminated, in whole or in part, for default. DHAT’s takes pride in the fact that our performance ratings are always outstanding or excellent.
If you would like additional information regarding our research division or any of the ongoing / completed studies, please contact our research coordinator – Brandi Scott.
Brandi Scott, MA, CCRC
Clinical Research Supervisor
Digestive Health Associates of Texas
1600 Coit Rd. Ste. 301
Plano, TX. 75075