Georgia
Georgia is our largest delivery base, with our own staff, site relationships and regulatory knowledge running deepest here. Local ethics committee first, then regulatory authority review. All submissions are made on paper, in person. Translations are notarised at a local notary. Safety reporting covers local and foreign SUSARs and the DSUR, with no cross-reports.
Country engagements
54 of our 81 country engagements since 2015. Quality of sites, fast enrolment in a relatively small country, short start-up timelines and short referral chains.
Review timelines
Local ethics committee four weeks, submitted first; regulatory authority review follows, 20–21 working days.
Observed review periods from our own submissions, not statutory best cases. Where a query round arises, add roughly a month.
What we offer there
- Our own CRAs, monitoring at site
- Our own regulatory specialists for authority and ethics submissions, in the local language
- Site identification, feasibility and qualification
- Site contracts and budget negotiation
- Import, export and clinical logistics