胃肠道和肝脏疾病的患者拼命地等待有效的疗法,因此临床试验的交付必须为成功提供一切机会。我们的胃肠病学和肝病学临床开发专家团队保持着不懈的关注,以进行创新和过程改进,以注册试验,并提供了安全和功效的明确证据。
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.
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.
人工智能的使用有助于IQVIA提高患者认同,而我们的全球足迹扩大了竞争较低的国家的临床发展机会。我们还使用改进的收集和解释过程来降低与组织学终点相关的风险。
在过去的二十年中,我们的治疗专家团队在200多个临床试验中建立了端到端能力,专业知识和数据资源。除了IBD和NASH外,这里还有其他一些领域
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