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?

  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  

  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  

Rare disease research depends on a solid understanding of the patient experience to succeed. Get our top 5 tips for operationalizing rare disease trials that put patients first in our latest eBook.

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