CLINICAL RESEARCH STUDIES EXPERIENCE

Proven by over 100 audits conducted by customers and third parties,all with positive conclusions and stating GCP compliance.

15 GCP inspections performed by EU regulatory authorities from Austria (3), EMA (1), France (3), Germany (3), The Netherlands (1) and Romania (4). Out of all the inspections, 9 were performed in Romania and 6 in Moldavia (last inspection performed by ANSM in June 2017). All inspections concluded with GCP compliance.

In November 2013 and May 2023, one of our clinical sites in Moldavia was inspected by the US-FDA. The inspections concluded without FDA Form 483!

In September 2014, our own clinical research facility located in Cumparatura, Romania was certified ISO 9001:2008.

Phase I

clinical studies can be performed:

In our dedicated privately owned clinical research facility, capacity 74 beds. Located in Cumparatura, Suceava County, Romania

In cooperation with Public Hospitals located in Chisinau, Moldavia. Capacity: 50 beds in one unit and 36 beds in a second unit and/or Romania

Phase II

to IV trials

Performed either in our own clinical research facility in Romania or in different hospitals from Romania and/or Moldavia depending on the investigational product and patient requirements
In case of studies requiring specific group of patients, several contacts with other hospitals are in place and new cooperation are continuously developed (Armenia, Bosnia, Georgia)

Clinical studies performed by 3S in Romania as well as in Moldavia were inspected by different European Authorities: French, Dutch, German, Austrian, Romanian, Danish on behalf of EMA, etc.; Moldavia also by FDA.