Gastroenterology and hepatology diseases have a high global prevalence and disease burden in the U.S. To meet the growing need of patients worldwide, the global gastrointestinal (GI) drugs market is projected to reach $62.19 billion in 2025. To support sponsors in bringing new therapies to this market, Gastroenterology CROs strive to bring their own innovations to CRO services with the promise of fast execution of high-quality studies. For example, a collaboration of a Gastroenterology CRO, an AI solutions developer, and a company working with endoscopy video capture tech was recently announced.
CRO Services for Gastroenterology Clinical Trials
CRO services for gastroenterology clinical trials refer to the use of contract research organizations to assist with the planning, execution, and analysis of clinical trials for gastrointestinal disorders. These services can include study design, protocol development, site selection and management, patient recruitment, data management, and statistical analysis. By utilizing CROs for these tasks, sponsors of the trial, such as pharmaceutical and biotech companies, can reduce their workload and ensure that the trial is conducted in a professional and efficient manner.
CROs can also bring a level of expertise to the trial that may not be present within the sponsor organization. This is particularly important for trials investigating new or complex treatments for gastrointestinal disorders, as CROs often have extensive experience in the field and can provide valuable insights into study design and regulatory requirements. Additionally, CROs can help to minimize the risk of delays or complications that can occur during a trial, allowing the sponsor to bring new treatments to market more quickly.
Below, we list the top ten CROs for gastroenterology clinical trials.
CRO #1: Altasciences
Altasciences is a mid-size CRO with over 25 years of experience offering integrated full-service solutions for preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. It has been recognized for its leadership, scientific, and operational excellence. Altasciences operations across North America include research and manufacturing facilities. For GI diseases, Altasciences has conducted more than 100 Phase I/II pharmacokinetic (PK) or pharmacodynamic (PD) studies, PK assessments, assessment of GI PD response using various methods, and full clinical pharmacology programs. A gastroenterologist with more than 20 years of experience in Phase I/II clinical research supports the clinical studies.
CRO #2: Caidya
Caidya is a global, multi-therapeutic CRO that emphasizes developing personalized partnerships and sharing expertise and knowledge over and above the resources sponsors need to conduct clinical trials. With its beginnings as Clinipace in 2003, it has grown through investment and mergers and acquisitions (M&A) to be named one of the top ten clinical trial services companies in 2018 and rebranded as Caidya in 2022. The Caidya Gastroenterology CRO has the depth and breadth of therapeutic expertise and knowledge of the global market to provide sponsors with personalized clinical research services. With their experience and understanding of gastroenterology subspecializations, Caidya offers help in identifying the most appropriate investigators and sites. In addition, Caidya helps identify, recruit, and retain suitable patients.
CRO #3: Criterium
Criterium, Inc. was started in 1991 to provide technology-based support for medical research. Since then, Criterium has widened the scope of its tech to connect all stakeholders to real-time data sources. It has expanded its services to include Canada, India, and South Africa and forged partnerships in the U.S., Russia, Australia, and New Zealand. The Criterium Gastroenterology CRO covers the following indications: Crohn’s Disease, diarrhea, Traveler’s diarrhea, ulcerative colitis, duodenal ulcer, functional dyspepsia, Irritable Bowel Syndrome (IBS) with constipation, heartburn, esophagitis, gastric ulcer, Fabry Disease, gastric cancer, Irritable Bowel Traveler’s diarrhea, and constipation. Criterium manages large-scale clinical projects and tailors the clinical research process to clients’ needs, from initial planning to approval.
CRO #4: Duke Clinical Research Institute
Duke Clinical Research Institute (DCRI) is an academic clinical research organization (ARO) combining the clinical expertise and academic leadership of a teaching hospital with a full-service CRO. Among the strengths described by DCRI, their researchers include practicing physicians with the insights and experience of executing trials in the realities of clinical care. The DCRI Gastroenterology CRO clinical operations teams offer comprehensive clinical trial services. In addition, DCRI offers specialized capabilities, including biobanking, genetics- and genomics-based technologies in clinical trial design, and outcomes research. DCRI collaborates with industry, government entities, and academia on drug development. It has coordinated more than 60 gastroenterology and hepatology studies involving over 10,000 patients across 800 global sites.
CRO #5: ICON
ICON is a global provider of outsourced development and commercialization services for drugs and devices. In 1990, ICON began in Dublin, Ireland, and now has a global network spanning 46 countries. ICON works across the drug development spectrum – spanning initial studies in Phase I to post-marketing studies in Phase IV. The ICON Gastroenterology CRO team includes dedicated drug development experts with experience running trials for experimental therapeutics across a broad range of GI-related diseases. In the last five years, ICON conducted 121 GI studies involving 34,363 patients enrolled in 7,973 sites worldwide.
CRO #6: IQVIA
IQVIA is a global provider of advanced analytics, technology solutions, and clinical research services to help customers accelerate their drug development journey to improve patient outcomes. It has approximately 85,000 employees in over 100 countries. Over the past twenty years, the IQVIA GI and Hepatology team has conducted more than 200 clinical trials. The team has built a repository of data, best practices, and research in inflammatory bowel disease (IBD) clinical development; and uses AI to advance patient identification for non-alcoholic steatohepatitis (NASH). Other areas in which the IQVIA team has experience include celiac disease, eosinophilic esophagitis, esophagitis, short bowel syndrome, gastroenteritis, microbiome, acute hepatic failure, cirrhosis, and pancreatic insufficiency.
CRO #7: Vial
Founded in 2020, Vial is a tech-enabled CRO driven by its mission to redesign the clinical trial experience from start to finish. Powered by clinical operations leaders with decades of experience, a best-in-class team of engineers, product managers, and designers from Silicon Valley, and its technology platform, Vial delivers faster and cheaper (by more than 50%) trials. Vial provides fast start-up and consolidated site activation, demonstrated by 90% of Vial sites being onboarded in less than 30 days. The company is based in San Francisco, CA, and has over 125 employees.
Vial established the specialized Vial Gastroenterology CRO supported by a team of scientific advisors who review and provide input on strategy and direction to build the infrastructure to advance gastroenterology research. Vial’s technology platform allows for streamlined processes for gastroenterology clinical trials, including fast start-up and site activation. Using its multi-channel marketing strategies and powerful technology, Vial can accelerate patient recruitment, as evidenced by recruitment times being cut in half. In response to the needs of sponsors, Vial offers fixed-pricing agreements with no change orders.
CRO #8: Medpace
Medpace is a mid-size, full-service global CRO for developing drugs, biologics, and medical devices. Founded in 1992, Medpace celebrated its 30th year in 2022 with over 4,800 associates in operations across 41 countries. The Medpace Gastroenterology CRO has specialized expertise in gastroenterology clinical research and an in-depth understanding of complex conditions associated with GI disorders. Operational teams are therapeutically trained, and GI experts have had hands-on experience conducting global GI studies. The Gastroenterology CRO has experience across indications, including autoimmune digestive disorders and IBD, functional/motility disorders, peptic ulcer disease, precision GI medicine, short bowel syndrome, liver diseases, and rare diseases within GI/hepatology.
CRO #9: PPD
Established in 1985, PPD is a leading global CRO with over 30,000 employees conducting trials in more than 100 countries. PPD provides comprehensive, integrated drug development, laboratory, and lifecycle management services. The PPD Gastroenterology CRO has clinical trial expertise in gastrointestinal and hepatology disorders. In the past five years, PPD worked on more than 110 gastroenterological trials with over 24,050 patients in upwards of 7,000 global sites. To accelerate the launch of studies, sponsors have access to PPD’s extensive database of fully identified and opted-in patients and their global network of over 180 dedicated research sites.
CRO #10: Syneos Health
Syneos Health is a fully integrated biopharma solutions organization that blends clinical development, medical affairs, and commercial capabilities to support sponsors in their drug development journey. Syneos Health has a team of over 29,000 supporting operations in more than 110 countries. It is in North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa. The Syneos Health Gastroenterology CRO is experienced in both adult and pediatric gastroenterology clinical trials and hepatology clinical trials. A dedicated gastroenterology/hepatology team supports the process. To keep up to date on the latest developments in research, clinical research associates (CRAs) work exclusively in this field.
Maximizing Efficiency and Expertise with CROs in Gastroenterology Clinical Trials
Maximizing efficiency and expertise in gastroenterology clinical trials can be achieved by utilizing contract research organizations (CROs). By partnering with CROs like Vial, sponsors can benefit from their extensive experience and specialized knowledge in the field of gastrointestinal disorders. This can help to ensure that the trial is conducted in a professional and efficient manner, minimizing the risk of delays or complications.
To learn more about how the Vial CRO’s tech-powered services are delivering faster, more efficient dermatology trial outcomes for dramatically lower costs, connect with a team member today!
