Princeton, NJ, USA, Nov 12, 2020
Global Clinical Trials is initiating a Phase I clinical study in Relapsed or Refractory Lymphoma for a US biotechnology company, OncoTartis, Inc.
“I am excited that clinical trials with our promising drug candidate OT-82 will now include several clinical sites in Russia. In preparation for this trial, our team was impressed by the knowledge, experience, and professionalism of people at GCT. I am confident that everything possible will be done to bring our trial to success despite the tough challenges posed by the Covid-19 pandemic” – Alexander Polinsky, Ph.D., Founder & CEO, OncoTartis.
GCT will be responsible for the local study management throughout all stages of the trial, including start-up activities, regulatory submission to Ministry of Health and Local Ethics Committees, project and site management, clinical monitoring, and the full cycle of thecomplex study logistics. GCT team will organize the IMP and CTMs import, customs clearance and local distribution to the sites, as well as biosamples export to the central laboratory. The IMP, ancillary supplies, equipment, and biosamples will be stored at GCT depot in Saint-Petersburg under required temperature regimes. In addition, GCT will manage the IMP preparation that must be performed individually before each administration. Our team is looking forward to achieving the first milestone – receiving the regulatory approval.
“We would like to thank OncoTartis for entrusting GCT such an important project. Given the limited number of treatment options available for this indication, we are excited to make our own humble contribution to the development of one,“ said Dr. Eugene Selivra, GCT CEO.
Proving clinical research services to pharmaceutical, biotech and device companies for over 19 years, GCT has gained extensive experience in various oncology studies, including multinational projects for European, US and Asian Sponsors.