Why EU CTR?
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).
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.
The new system harmonises the submission and assessment processes of clinical trials throughout the EU countries.
If you plan to submit a clinical trial in the EU, please get in touch with us.
We will prepare the set of necessary documents for the application and submit it on your behalf.
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]
Negotiating clinical agreements
[ Vendors management ]
Selecting vendors
[ Principal Investigators
Meetings ]
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