The COVID-19 pandemic has brought unprecedented challenges in clinical development. Travel restrictions, social distancing and the fear of contracting the disease are impeding conventional trial conduct.
As drug development sponsors are incorporating patient-centric elements into their traditional clinical trial designs, there are several factors to consider during the study planning phase.
The impact that external events like the COVID-19 pandemic can have on clinical trials, as well as a company's entire drug development portfolio, can be far reaching. Tracking metrics associated with these crises is essential to enable study teams to follow global trends of the impact.
During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements in genomic and molecular biology, a viable vaccine approval is still likely to be over a year away.
Decentralized trials (DCT) are a hot topic to help solve clinical trial challenges. However, making DCT a reality requires a holistic shift in trial design and execution. Integrated systems, processes and tools are needed to support this transition.
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.
