Videos

Clinical Trial Jenga™: What to do when you are debating your next move

Clinical Research

Despite its simplicity, Jenga™ is a game that requires much thought and delicacy – just like a sponsor’s choice of CRO to implement their clinical trial. When you experience delayed recruitment, extended timelines, expanded budget, team turnover, or consolidation of your CRO, you’re left questioning what to do next. Could one wrong move be like removing the wrong block from your Jenga™ tower?

White Papers

Utilizing a Registry to Inform an External Control Arm: A case study in drug-induced liver injury

Endocrine and Metabolics, Rare Disease

  Clinical trials that rely on external data sources to provide a control arm pose an attractive alternative to an internally administered control group. In principle, they give study participants a higher likelihood of exposure to the developmental therapy, which is a particularly desirable proposition when the disease in question has high morbidity or mortality. This whitepaper explores the utility of registry data applied as an external control arm, providing a step-by-step description of the process in a real-life study.   View Article  

White Papers

A Tale of Two Agencies: FDA and EMA Regulatory Guidance for NASH and the Impact On Program Design

Cardiovascular

  Both the EMA and the FDA agree that identifying therapies to slow, halt, or reverse NASH/ NAFLD in patients represent a significant unmet need. Appropriate guidance has been structured to inform clinical programs across all key design elements, particularly for potentially pivotal trials. And although regulatory guidance may articulate similar strategic objectives, the detail required for program design and execution may deviate by phase of research. This whitepaper examines methods of reconciliation enabling one strategically focused clinical development program.   View Article