Why EU CTR?
​
Planning to run a clinical trial in the European Union!
![Original on Transparent 2[12711]_edited.](https://static.wixstatic.com/media/9a970e_e8a399da153846f285ec94b425519208~mv2_d_1384_1384_s_2.png/v1/fill/w_97,h_96,al_c,q_85,usm_0.66_1.00_0.01,enc_auto/Original%20on%20Transparent%202%5B12711%5D_edited_.png)
<
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