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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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9th PREDiCT: Tumor Models Cell Therapy Summit

pharmaphorum

Join over 28 world-class speakers to see how classic and next-gen tumor models can be leveraged to expand your mechanism of action understanding, model the complexities of the tumor microenvironment, and guide your clinical design. Aaron Goldman , Director, Drug Resistance Group, Harvard Medical School.

In-Vivo 52
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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.