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How Can You Manage the Complexity of Early Phase Clinical Development?

XTalks

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. And that has a lot of downstream consequences.”

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Global decentralized studies will become a standard clinical trial design approach

The Pharma Data

“Studies will embrace decentralized trial approaches as design options earlier in the clinical trial 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. .

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Common Pitfalls in Preparing an IND Application

Advarra

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). There are a myriad of regulations coming into play during the drug development process. Developing a relationship with the agency team reviewing the submission.