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EU CTR Readiness

Are you ready for the new European Union Clinical Trial Regulation (CTR) 536/2014 requirements? They’re taking effect in 2021, and failure to comply could make your company ineligible to launch new drugs in the EU. Take this short readiness assessment to evaluate where you are and find out your readiness score.

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* 1. Let us know where to send your personalized report.

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* 2. PEOPLE STRATEGY: How much do your stakeholders understand about the changes required by EU CTR 536/2014?

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* 3. PROCESS STRATEGY: How ready is your organization to meet the new submission process and patient safety requirements of EU CTR 536/2014?

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* 4. TECHNOLOGY STRATEGY: How ready is your organization for the change management required by EU CTR 536/2014 technical and operation plans?

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* 5. PEOPLE ENABLEMENT: Does your organization have a training and development curriculum in place to ensure compliance, meet audit requirements, and adopt effective organizational change?

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* 6. PROCESS EXECUTION: Does your organization have processes in place to address EU CTR 536/2014 mandates for increased data safety and transparency?

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* 7. TECHNOLOGY EXECUTION: Does your organization have training and development plans in place to ensure that your teams are compliant with new technical requirements of the Clinical Trials Information System (CTIS)?

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* 8. Do you have other concerns about readiness for EU CTR 536/2014 that you would like to share with us?

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