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In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinicaltrials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”
“Studies will embrace decentralized trial approaches as design options earlier in the clinicaltrial planning process,” Reites said. Sponsors and CROs will continue to be eager to bounce back and accelerate the drug development process after significant delays caused by the pandemic,” Reites said. .
As a drug successfully makes it through the development process, sponsors will inevitably need to submit a new drug application (NDA) to the Food and Drug Administration (FDA). Failure to Have a Pre-Investigational New Drug (IND) Meeting. Failure to Have a Pre-Investigational New Drug (IND) Meeting.
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