GI and Hepatology

When patients are waiting, failure is not an option.

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 innovation and process improvement to enroll trials and provide clear evidence of safety and efficacy.

IBD success rates exceed industry average

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 30 phase II and III IBD trials since 2015 (greater than 25% of all outsourced trials), 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 30 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.

NASH evolves with greater opportunity for success

Nonalcoholic steatohepatitis (NASH) 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 NASH 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.

doctors reviewing information

Over two decades of therapeutic experience

Our team of therapeutic experts have built end-to-end capabilities, expertise, and data resources across more than 200 clinical trials over the past two decades. In addition to IBD and NASH, here are some other areas we are experienced in

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

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