Allied Digestive Health’s Department of Clinical Research is committed to targeting unmet health needs and providing our research patients access to necessary treatments. Focused on providing the best quality of care to our research patients, we aim to deliver a positive experience in every interaction through our advancement of technology, patient care, and research for patients with gastrointestinal disorders.
Our clinical research team has extensive experience with clinical trials and prioritizing patient safety. We adhere to all FDA regulations including following the principles of Good Clinical Practice (GCP). As an additional form of safety, all clinical trials are approved by an independent Institutional Review Board (IRB). By closely monitoring your health, we pledge to provide quality care personalized to individual health needs.
What is Clinical Research?
Clinical research is the study of health on individuals through examination. Research allows us to gain a better understanding of a variety of diseases and make continuous improvements.
With the introduction of innovative technologies, we are committed to adopting new technology that make studies safer and more effective. Clinical research allows us the opportunity to provide a transformative impact for our patient, and simultaneously increase our medical knowledge.
Why Participate?
- Opportunity to benefit from new treatment
- Quality care from top doctors and researchers
- Low to no cost, with possible compensation
- Contribute to saving lives in the future
- Take control of your care
Why Perform Clinical Research?
Clinical research is an essential aspect of improving patient care as it allows physicians to discover new methods of detection, diagnosis, treatment, and prevention. Clinical research is the fastest way to find effective treatments. Without clinical research, our knowledge revolving around clinical care would cease to exist.
How Does the Process Work?
At Allied Digestive Health, we are focused on providing patients with the best clinical trial experience. That’s why we take the time to exam all patient information including nutrition, behavioral health, and the effects of the gastrointestinal disease on the patient’s well-being. With a knowledgeable team of physicians and health care professionals, we are able to provide you with a personalized experience throughout the entire process.During the Trial
Almost every clinical trial will follow this five-step process:
Your Rights in a Clinical Trial
- You have the right to address any concerns at any time
- You have the right to understand all other treatment options that are available.
- You have the right to privacy and confidentiality with personal information including removal of personal identifiers from study documents
- You have the right to access your data.
- You have the right to withdraw from a clinical trial at any time.
- You have the right to quality care
Crohn’s Disease
- Participant must be between 18 and 80 years of age
- Diagnosed with Crohn's disease
Crohn’s Disease
- Participant must be ≥ 18 years of age
- Diagnosis of Crohn's disease established 3 months prior to enrollment
Ulcerative Colitis
- Participant must be ≥ 18 years of age
- Diagnosed with ulcerative colitis
- Received previous colonoscopy
Ulcerative Colitis
- Participant must be between 18 and 85 years of age
- Experiencing signs/symptoms of moderate to severe ulcerative colitis
Ulcerative Colitis
- Participant must be between 18 and 80 years of age
- Diagnosis of UC established 3 months prior to enrollment
- Have moderately to severely active UC as defined by a modified Mayo score of 5 to 9
Ulcerative Colitis
- Participant must be between 18 and 75 years of age
- History of ulcerative colitis
Colorectal Cancer Screening
- Participant must be ≥ 45 years of age
- Have not been diagnosed with active cancer
Erosive Esophagitis
- Participant must be ≥ 18 years of age
- Experienced both heartburn and regurgitation recently
Nonalcoholic Steatohepatitis (NASH)
- Participant must be between 18 and 75 years of age
- Have type 2 diabetes or obesity, high cholesterol, high blood pressure or sleep apnea
- Have fatty liver disease (can be diagnosed at screening)
Fibrosis
- Participant must be between 18 and 75 years of age
- Have type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose)
- Have liver fibrosis (can be diagnosed at screening)
IBS-D
- Participant must be ≥ 18 years of age
- Have IBS with diarrhea
- Have stomach pain from diarrhea
Diabetic Gastroparesis
- Participant must be ≥ 18 years of age
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Diagnosis of Type 1 or Type 2 diabetes
- Current diagnosis of diabetic gastroparesis
NASH Fibrosis
- Be 18 to 75 years of age
- Have NASH or symptoms of Liver Disease
GERD
- Participant must be ≥ 18 years of age
- Have acid reflux or GERD confirmed by endoscopy
- Heartburn must be reported on 4 or more days during any consecutive 7-day period of the Screening Period
Cirhosis
- Be 18 to 70 years of age
- Diagnosis of advanced liver cirrhosis
Sponsor
AHCRO was formed as an entity of ADH with the goal of offering our patients access to the many benefits of clinical research in a community setting. AHCRO is committed to providing our research participants with a safe and enjoyable research experience, and our industry partners with clean, usable data.
A few highlights of our program:
- All major GI & hepatology indications treated
- Large & diverse patient population and referral network
- Access to a wide variety of GI/Hepatology diagnostic services, including endoscopy, liver biopsy, MRIs, and elastography
- Committed to rapid CTA, budget & regulatory turn-around timelines
- Utilize Central IRB
- Dedicated & experienced research team, all extensively credentialed in clinical research, including IATA certification including training in GCP
- QA/QC program to complement risk-based and remote monitoring
- Ongoing staff training/education beyond basic GCP requirements (FDA Guidelines and common findings, documentation best practices, AE assessments, PI oversight, roles and responsibilities, quality assurance, etc.)
- Experience in a variety of EDC and IVRS/IWRS systems
- Investments in a fully integrated eSource, eReg, CTMS solution through CRIO (Clinical Research IO) to ensure efficiency and compliance.
- 100% remote monitoring capability
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