EU-CTR

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Navigating EU-CTR Compliance with Workflow Automation

EU-CTR aims to harmonize the clinical trial assessment and supervision process across EU member states. This regulation has made it convenient for sponsor organizations to keep track of their applications and for regulators to process them more efficiently. However, navigating the complexities of EU-CTR compliance can be challenging for organizations, particularly when their organization is […]

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Shortcast 3 Workflow Automation Regulatory Submissions

Shortcast Episode 3: How does Workflow Automation Streamline the Regulatory Submissions Process?

  The regulatory submissions process can span multiple countries, and with people working remotely, using rudimentary tools like Email, Excel and SharePoint, it doesn’t provide the visibility into the latest submission status, thereby limiting the regulatory team’s ability to make effective decisions. This could potentially delay the regulatory submission process. At Princeton Blue, we recently

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