In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses recent Complete Response Letters issued to Replimune and Capricor, explaining how shifts in FDA reviewers can affect ...

The global Phase III EMPEROR trial (NCT06872125) will evaluate the safety and efficacy of zorevunersen, a novel antisense ...

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the previous week with a look into the FDA’s heightened scrutiny of trial design, the wind-down of ...

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, examines how recent developments with Complete Response ...

Conducting Large Simple Trials to answer questions about "real-world" medical interventions is not a recent concept.

Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.

Vice President, Patient Centered Solutions, IQVIAThe study protocol and a set of specifications are the road map for developing the software and the support structures for an EPD study.

Applied Clinical Trials is the thought leader in pharmaceutical drug development operations and clinical trial design, management, and monitoring.

Advances in our understanding of the genetic, immunological, and environmental factors that contribute to the pathogenesis of psoriasis have led to the development of very effective precision ...

Results from the Phase III EPCORE FL-1 trial (NCT05409066) showed that patients treated with Epkinly (epcoritamab) in combination with Rituxan (rituximab) and Revlimid (lenalidomide) for relapsed or ...

While DCTs failed to transform clinical research, artificial intelligence (AI)-powered study approaches are now fulfilling their promise within the non-interventional research space. Unified, digital ...

In the Phase III ENVISION trial, Zusduri achieved a 24-month duration of response rate of 72.2% among patients with a ...