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Why EU CTR?

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Planning to run a clinical trial in the European Union!

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Original on Transparent 2[12711]_edited.

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CROPRIME has implemented a new EU CTR submission process (required by a new pharmaceutical law: Regulation (EU) No 536/2014).

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Under a new law it is required to submit one online application via a single online platform known as the CTIS for approval to run a clinical trial in several European countries.

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The new system harmonises the submission and assessment processes of clinical trials throughout the EU countries.

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If you plan to submit a clinical trial in the EU, please get in touch with us.

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We will prepare the set of necessary documents for the application and submit it on your behalf.

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Link to the new regulation:
https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation​

CONTACT US!

Thanks for submitting!

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[ Feasibility ]

 

Assessing and evaluating the capacity and capability

[ Study set up ]

 

Planning and developing the idea

[ Contract management]

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Negotiating clinical agreements

[ Vendors management ]

 

Selecting vendors

[ Principal Investigators

Meetings ]

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Organizing the venue

 

[ Clinical monitoring ]

 

Monitoring activities from evaluation to close out visit

[ Clinical Trial Audits and QA/QC  ]

 

Managing audits and inspections

[Clinical Project design]

 

Designing the study protocol

[ CRF design ]

 

Preparing for clinical data collection

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