Through this webinar our though leader will discuss lessons learned and case studies from supporting unique biosimilars across the development spectrum. Learn about Chemistry, Manufacturing and Controls (CMC) characterization and the use of CMC analytical master files to support the assessment of biosimilarity and reduce downstream development risks.

Hear from our thought leaders who discuss new strategies to improve patient recruitment.

Through this presentation our thought leaders share strategies on drug development processes instituted for the COVID-19 Era.

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As clinical trials are incorporating an increasing number of sources of non-case-report-form (CRF) data from wearable devices and various laboratories, management of clinical data must address larger, disparate volumes of external data sources.

This webinar explains the steps involved in Medical Monitoring of CAR T therapy and explores additional considerations during COVID 19

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.