Why does data quality and traceability matter? Are you getting what you pay for? What resources are required for running a Fit For Filing trial?
Academic trials are not usually part of the marketing authorisation process of a new drug. But why is that? Let’s explore how we can open up this opportunity to enable academia-industry collaborative trials to deliver data that can be used for licensing purposes (fit for filing).
Academic trials are not usually part of the marketing authorisation process of a new drug. But why is that? Let’s explore how we can open up this opportunity to enable collaborative trials to deliver data that are fit for filing.
Early collaboration and communication between all stakeholders is crucial to develop better trial protocols and to collect adequate data and documentation for a marketing authorisation application for a new drug.
Why does data quality and traceability matter? Are you getting what you pay for? What resources are required for running a Fit For Filing trial? Let’s explore data management, oversight, and the consequent resource considerations for fit for filing trials to improve the collaborative model and reach the common goal of filing an application.
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