Global Clinical Trials is managing its first local project in the country of Georgia. It is a recently awarded observational Phase IV clinical trial in Multiple Sclerosis.
GCT team is performing local management of the multinational study sponsored by an international Big Pharma. It includes trainings, regulatory documentation handling, adjustment and submission of amendments, site monitoring and close-out, and the eTMF maintenance.
Georgia is known for the fast regulatory approval of
clinical trials, which only takes 30 working days. The submission package is
similar to that in the EU countries.
While the clinical trials market in Georgia is still
emerging, the key aspect is to find the CRO with local expertise. As a boutique
CRO with the focus on CNS and Neurology clinical studies, we are proud to share
our insight during this trial. The executive oversight is provided from both
GCT President, Dr. Jeffrey Apter and CEO, Dr. Eugene Selivra who are trained
psychiatrists with 50+ years of combined experience in clinical research.
For any inquiries about CNS and Neurology clinical trials,
and clinical trials in Georgia, please get in touch with GCT BD team at bd@gctrials.com.