Many drug development sponsors are interested in understanding how a digital biomarker strategy can improve patient-centricity their trial. However, may feel uncertain about where - and sometimes even why - to start.

The integrated summary of safety (ISS), integrated summary of efficacy (ISE), and Study eSubmission deliverables are considered key components of a New Drug Application (NDA) for the U.S. FDA as well as other regulatory agencies around the world.

Biomarkers play a critical part in reducing scientific, regulatory and commercial risks and accelerating CAR T-cell development.

When the global clinical trial industry was suddenly forced to adapt to unprecedented challenges, traditional trial conduct models were upended. Some trials were delayed or even cancelled. Yet other trials thrived and still more were able to restart after adopting decentralized clinical trial (DCT) methodologies.

You want to eliminate the burden of managing external data sources, so do we. Join our session to learn about the latest technologies and methodologies used to manage external data sources.

At Covance, they know that time is of the essence across their diabetes trials. Developing these trials in the most cost-efficient manner makes upfront planning crucial, but interrogating the best data resources to augment team expertise is a difficult task.

Preserving Data Quality in Phase I Studies During COVID-19: A CRO's Perspective from the ExL Clinical Quality Oversight Forum recorded on October 21, 2020.

Effective portfolio and trial oversight is essential to ensure that all studies are managed consistently, are of high quality and are kept on track. Recent global events coupled with the general industry shift to a risk-based quality management approach for clinical trials have demanded a new outlook on trial management.

Inhaled studies are often perceived as technically challenging, and varied regulations around the world add another level of complexity.

Bird's eye view of the new automated kit production line, now open for EMEA investigator sites at our European Operations Center.