Success is imperative when patients are waiting

Driving innovation in gastroenterology and hepatology trials, with relentless focus, advanced technology, and evidence-based outcomes. 

Our steadfast commitment

Patients with gastrointestinal and liver diseases are desperately waiting for effective therapies, so delivery of clinical trials must provide every opportunity for success. Our team of gastroenterology and hepatology clinical development experts maintain a relentless focus on reliability: data-driven strategies to enroll trials and primary endpoint protection to provide clear evidence of safety and efficacy.

Excelling in IBD Trials: Experience enables reliability

IQVIA has an 88% higher success rate for Phase II and 25% higher for Phase III across Inflammatory Bowel Disease (IBD) trials as compared to industry rates. Having run more than 50 phase II and III IBD trials since 2017, we manage the challenges of operational delivery every day. Competition for sites and patients is intense, and patient-reported outcomes and endoscopy must ultimately demonstrate clear efficacy for approval. Years of experience have enabled us to build a repository of data, best practices, and research to continuously improve IBD clinical development. Performance data from more than 40 trials in the last five years power site identification. New technology improves the quality of patient reported outcomes. And advancements in endoscopy algorithms obtain higher separation between placebo and active treatment.

Facts

Enroll with confidence Utilize Connected Intelligence to navigate a competitive landscape and mature market of treatment options to identify sites with the greatest enrollment potential. Reduce patient burden Offer flexible visit options to enhance study participation, promote compliance, and reduce study burden. Protect PRO data quality Standardize patient training with patient-centric tools and monitor PRO data to address issues in a timely manner. Obtain high quality endoscopic videos Reduce the risks associated with patient bowel prep and endoscopy technique. Improve accuracy of endoscopy interpretation Utilize a central reader model that reduces intra- and inter-reader variability to increase separation between study drug and placebo.

MASH evolves with greater opportunity for success

Metabolic Dysfunction-Associated Steatohepatitis (MASH) represents a public health issue around the world, yet most patients are unaware of their risk for this disease. Underdiagnosis coupled with high screen failure in a highly competitive landscape continues to slow recruitment of phase II and III trials. And meeting histological endpoints has been a challenge on phase II and III MASH trials due to variability in sample collection and interpretation. Use of artificial intelligence has helped IQVIA advance patient identification, while our global footprint expands opportunities for clinical development in less competitive countries. We also reduce the risks associated with histological endpoints using improved processes for collection and interpretation.

Facts

Enroll with confidence Leverage Connected Intelligence and a global site network in >60 countries to navigate a competitive landscape and penetration of GLP-1 agonists to identify sites with the greatest enrollment potential. Minimize screen failure Utilize predictive risk factors to identify undiagnosed patients with the greatest probability of MASH to reduce screen failure. Identify the right patients Utilize a structured pre-screening process to identify consent-ready patients before site activation to reduce time to FPI and the risk of non-enrolling sites. Protect your primary endpoints Manage risks associated with acquisition and central reading of imaging and liver biopsies to increase the probability of positive study outcomes.

Over two decades of therapeutic experience

Our team of GI therapeutic experts have built end-to-end capabilities, expertise, and data resources across more than 200 clinical trials over the past two decades. Beyond IBD and NASH therapeutic areas, we bring our extensive experience to a variety of other areas.

• Celiac Disease
• Eosinophilic Esophagitis
• Erosive Esophagitis
• Short Bowel Syndrome
• Gastroenteritis
• Microbiome
• Acute Hepatic Failure
• Cirrhosis
• Pancreatic Insufficiency