First Patient In Acute Infection Clinical Trial In Russia
Despite the COVID-19 challenging the routine of clinical trials worldwide, Global Clinical Trials has successfully randomized the first patient into a clinical trial evaluating the efficacy of IP in the sore throat pain relief.
This is a phase IV, multicenter, randomized, non-inferiority trial aiming to enroll over 300 patients globally. The first patient was enrolled only 4 days after the site activation.
October 8, 2020
Database Locked for the Rare Disease Pediatric Study
GCT team is proud for taking part in achievement of the major milestone for the Phase III clinical trial.
The study is being successfully conducted, amidst the present difficult global environment, in pediatric patients suffering from a rare neurological disease. In January 2020, GCT has successfully completed the enrollment of patients in Russia. We have now reached the next milestone – the Database Lock.
September 7, 2020
Multiple Sclerosis Observational Study in Georgia
Global Clinical Trials is managing its first local project in 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.
September 1, 2020
New Phase I Breast Cancer Study Awarded in Russia
GCT has been awarded a new Phase I clinical trial in patients with breast cancer. It aims to prove the safety, tolerance and pharmacokinetics of the Investigated Medical Product (IMP) using the dose escalation method. The study will be conducted in Russia with enrolling 60 patients who suffer from palindromic or refractory metastatic breast cancer. The project is sponsored by a Russian biotechnology start-up company specializing in oncology research.
August 3, 2020
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2020, November 4—7