Setting up a clinical trial may seem to be a very complicated mission for those who know what it takes. Although it is easy to define a certain number of standardised steps, the process must be tailored to the specificity of the study. In Italy, those steps can be very specific and strict. Thanks to ClinOpsHub’s experience and presence on the national territory, we are the right solution for you!

 

Our Start-Up Team expertly deals with managing and submitting study documentation to the Italian Competent Authorities and Ethical Committees, abiding by local regulatory indications. Under our belt, we have successfully managed several studies in various therapeutic areas (from systemic sclerosis, melanoma, cystic fibrosis, infectious disease, breast cancer, radio-oncology and rheumatology) and are currently working on some exciting and promising projects.

 

Working closely with our Quality Assurance Team, we make sure that all aspects of the study start-up process are addressed and help you obtain the SIV-ready status in no time at all with an accuracy oriented approach.

 

Starting from these experiences, we created the “SIV Ready” Service, a bundle of operations necessary to reach our common goal: running your trial. 

 

Our Service was born for simplifying your working activities.

 

We can take care of your study, bringing it from site selection and document collection to the Site Initiation Visit.

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In fig 1. Above is a brief description of the activities we carry out to make your study Start-up as easy as 1, 2, 3.

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The "SIV Ready" service consists of:

1. Execution of CDAs

2. Potential Sites Identification

3. Site Feasibilities and selection of Investigators 

4. Pre-Study Visits 

5. Document Collection

6. Regulatory and Ethical Submission

7. Contract Negotiation

8. Site Initiation Visits

9. Follow up on the SIV and ICH-GCP site personnel training and activation of necessary accounts required for the study

 

If you are satisfied with our services, let’s keep our relationship alive! We can support you further with the following services to come round full circle.

 

1. Site Coordination and phase I-IV study management

2. Project Management

3. Study Monitoring

4. Protocol amendment(s)

5. Study Closure

 

Our experience is focused on both IMP and Medical Device studies (both interventional and observational). 

 

If you’re thinking about running a clinical trial which involves sites in Italy, if you are looking for a no-problem, hands-on team, contact us so that we can support you to satisfy your requirements.

 

We tailor our services to satisfy your needs, so the dress fits every time.

 

We can support You!​

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