SANO CRO
USA
628 Island Place, Redwood City, CA 94065
650-594-1031
nmdjordjevic@ gmail.com
Serbia
Beograd 11120 XXI Divizije 41, Belgrade, Serbia
381-11-2414416
Conducting Clinical Trials
Serbia
has substantial experience as a host for clinical trials, going back to
before the 1990s. Several major institutions were established to conduct
academic and commercial research
over the past several decades.
Contract research has been defined as one of four leading investment opportunities in the Balkan region by the US Agency for International Development, since 2002. This Agency has located its main office in the Serbian capital, Belgrade, with the mission of promoting this sector, amongst others, for foreign investment and domestic consolidation.
A ground force of Doctors of Medicine (MDs) as clinical research associates (CRAs) and Clinical Project Managers (PMs), strong medical schools and solid exchange of knowledge on post-doctoral levels are all preconditions for safe and efficacious clinical research carried out in Serbia.
Patients
Patients are within easy reach of investigators via well-defined medical
services of primary, secondary and tertiary institutions. Patients are
an ideal source of experimental scientific insight. They are typically
well diagnosed, often under-treated (certainly in comparison to Western
standards) in terms of multiple therapeutic approaches and are more and
more critically of
towards novel medicine.
Trials
Phase I units start to exist and those repatriated from abroad seek partners
in setting their own facilities in this favourable economical region.
Selling such services to countries in the region that lack such facilities
is an attractive option. Serbia is in the middle of South Eastern Europe
(SEE) and its trade area, providing duty-free access to a regional market
of 55 million people.
Furthermore,
Serbia is the only country outside of the Confederation of Independent
States (CIS) that enjoys a free trade agreement with Russia, offering
customs-free access to its market of 150 million people.
Regulatory
Review processes on local
and ethical levels, as well as regulatory input are well defined and documented
in their standard operating procedures (SOPs). Bilingual templates are
available for main documents required in a trial approval dossier. From
March 2007, the IL procedure will be easier for the Serbian authorities
(customs, regulatory and health) working under a ‘Study ID’.
All data are supplied in this ID, so even multiple imports can be covered
under one permit.