Not exact matches
«Many investors expected a more lengthy FDA review process of the JCAR015
trial (and potentially
other CAR - T programs) and feared that a higher - degree regulatory scrutiny could increase the development risk of CAR T cell,» Leerink Research said in a note co-authored by analysts Michael Schmidt, Ph.D., Jonathan Chang, Ph.D., and Varun Kumar, Ph.D. «While it may take several weeks to reopen all
clinical sites of the ROCKET
trial, we believe the
trial shouldn't be delayed by more than ~ 3 months.»
He is one of six patients participating in the
clinical trial, which is being conducted at the University of Southern California and five
other sites across the country.
Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or
clinical studies,
clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or
other disputes.
Collateral benefits to
clinical trial sites include equipment and facilities, skills development, high - quality jobs for local researchers, healthcare workers and
other staff, and generally a higher standard of healthcare for
trial participants.
The overall purpose of this position is to support drafting, negotiating and interpretation of complex commercial arrangements with international
clinical trial sites, vendors, technical experts and
other counterparties.
Assisted seven
clinical study teams in the execution of
clinical trials, including the following activities: developed and maintained tracking tools, prepared minutes from meetings, prepared mailings to investigational
sites, assisted with investigational
site payments and budget oversight, inputted drug orders, randomized patients, and performed
other study specific projects per the needs of the study team