“No amount of experimentation can ever prove me right, a single experiment can prove me wrong”
What we offer ?
Providing clinical operations services means that we are able to perform all activities required from the bid defence meeting until site closeout:
- Sites identification and selection
- Study Document Development
- Project Management
- Clinical Operations including site initiation, routine monitoring visits and site closeout
- Monitoring visits performed by experienced CRAs
- Regulatory Affairs, including submission of trials to local authorities
Why to outsource these services to us?
The reason for such a high number of investigational sites in Romania consists of some particularities such as the large number of university hospitals, the large number of universities as well as the high rate of recruitment among subjects. In comparison with European standards, more doctors with GCP accreditation are hired by the universities hospitals.
Moreover, the monitoring costs, as well as the costs with investigators, are consistently lower than in Western Europe. Passthrough costs are also lower in Romania, estimations showing that the total monitoring costs being around 70% from similar services across Western Europe.
We guarantee the quality of our services as long as we do not expand in areas where are not the best of. We provide pure clinical operations.
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