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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.

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Global decentralized studies will become a standard clinical trial design approach

The Pharma Data

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. . These focus areas will materialize in study designs as hybrid decentralized approaches that support global programs,” Reites said. β€œIn Source link: [link].

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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). Failure to Have a Pre-Investigational New Drug (IND) Meeting. Failure to Have a Pre-Investigational New Drug (IND) Meeting.