Why EU CTR?
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Planning to run a clinical trial in the European Union!
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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​
[ 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