GCT organizes Investigators’ Meeting for medical device study in Romania
GCT started the new year with conducting an Investigators’ Meeting on behalf of the European Sponsor – NanoGun Technology (NGT). NGT is an innovative company certified by the French government in nanomaterial biotechnology. IMDENDRIM is an experimental in situ anticancer treatment of solid tumors nonresponsive to conventional therapy.
The IM for IMDENDRIM study, which will be performed in Romania in patients with inoperable liver cancers non-responding to standard therapy, was organized to train investigators and their clinical staff on trial related activities, discuss the protocol, study design, standard operating procedures, GCP, GDPR and other topics. The meeting was held online due to travel restrictions. Attendees from France, Germany, Belgium, Romania, and China participated in the meeting, including the Sponsor representatives, Investigator site team and the CRO team.
“IMDENDRIM is an intelligent nanomedicine device that is ideal in situ treatment for inoperable and non-responding to conventional therapy tumor,” – Pr. SADEG Nouredine, PhD, Chairman of NGT.
“GCT has a vast experience in conducting clinical trials in oncology, and this exciting project is an opportunity to enhance it. Our team will be closely working with the study site to meet the recruitment goal, which will allow the Sponsor to continue with the technology registration in the EU and other regions,” – said Dr. Eugene Selivra, GCT CEO.
Within the study, GCT is responsible for the regulatory support, project management, clinical monitoring, medical writing, data management, biostatistics and CSR. In addition to conducting the trial, GCT will be supporting NanoGun Technology (NGT) with gap analyses and registration in the USA, China and the EU.
Updated: January 25, 2021