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Clinical Design

Clinical Trials

Global decentralized studies will become a standard clinical trial design approach

The Pharma Data

MARCH 20, 2021

After a year of unprecedented disruption in the clinical research industry, 2021 is set to be another transformative year for sponsors and contract research organizations (CROs), according to John Reites, president of Thread, a technology and service provider focusing on decentralized clinical research. Source link: [link].

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Common Pitfalls in Preparing an IND Application

Advarra

JUNE 28, 2022

Using nonclinical data or manufacturing information that doesn’t adequately support the clinical protocol hurts the IND application. It’s critical to ensure all nonclinical data supports the clinical design and provides adequate justification of the desired labeling claims – including basic exposure data. Inadequate Support.

Regulation

Regulation Drugs Manufacturing Development

Global decentralized studies will become a standard clinical trial design approach

Common Pitfalls in Preparing an IND Application

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