From all of us at Global Clinical Trials
2019 PROJECTS OVERVIEW
In 2019 GCT enhanced global clinical operations across United States, EU countries and Eastern Europe. This year we have been awarded with several large multinational clinical trials and we are proud to deliver great results to our clients. Main achievements this year were already in our highlights:
Expanding GCT operations in 2019, we initiated our first projects in Western Europe. The innovation-driven environment of the region continues to attract pharmaceutical companies for clinical research. Moving along with the dynamic climate of the clinical trial industry and expanding GCT operations, we have received the regulatory approval for two studies in Rare Dermatology Indication in Germany.
A difficult and yet exciting Pediatrics study was awarded to GCT this summer. The Phase III trial is to enroll up to 20 children and young adults with a debilitating Rare Genetic Mutation in Russia only. It is a double-blind, randomized, placebo-controlled study that will be followed by a long-term open-label treatment. GCT received the Regulatory Approval for this study in under 60 days in Russia. We also organized the Investigator Meeting that took place early October. (read more)
GCT was also awarded another Orphan Disease study in Russia. For the Phase III b trial designed to assess the safety and efficacy of a rare metabolic condition, we have successfully managed Russian sites. (read more)
Russia and Eastern Europe often facilitate a faster recruitment of patients compared to many other regions — a significant criterion for sponsors when choosing the country for clinical research. In 2017, GCT started its participation in the multi-country Phase III Cardiac Surgery Study. We were responsible for managing 1 site in Russia up until 2019, when the sponsor chose to enhance the patient enrollment rate by opening 4 additional sites. (read more)
Kangen Pharmaceuticals too decided to expand their Phase II study in gastroenterology by opening sites in Russia and Ukraine. Study is currently at the start-up stage with a goal to recruit 164 patients for the global project. (read more)
A monitoring project was awarded to our company in Czech Republic. GCT performs intense monitoring for a 3-week in-vitro diagnostic device study. (read more)
As we were initiating new trials, we also kept focus on the ongoing projects. In the year 2019, GCT, together with our clients, reached some important milestones:
- Enrollment completion for the Phase II Ulcerative Colitis trial
- Approval and Start of Enrollment for the Phase III Ophthalmology trial in Russia
- Database Lock for Women’s Health Phase III study in Russia, Ukraine, Bulgaria, Hungary and Czech Republic
- Database Lock for Non-Hodgkin’s Lymphoma Study in Ukraine
- Site Initiation Visits and Enrollment kick-off for the Phase II Alzheimer’s Disease study in the USA
- Regulatory Approval for the Oncology Study in Romania
- Investigator Meetings for Phase II Ophthalmology and Dermatology trials and Phase III CNS trial
- Investigator Meeting for the study in Chronic Pancreatitis
Award of a phase IV study to compare the efficacy and safety of two methods of IP administration in patients with acute sore throat in Russia with aim of enrolling up to 160 patients. The project is currently in the active start-up stage.
2019 OFFICES
As we expanded our operations, our staff count grew as well. In order to facilitate a comfortable environment and plenty of space for everyone, we moved offices in three countries:
- GCT office in India
2019 CONFERENCES & EVENTS
Every year we attend all the important global and local conferences dedicated to clinical trials. 2019 was not an exception, and here are our highlights:
We enjoyed meeting our present and potential partners, connecting with fellow professionals and even had a raffle at our booth… with a very special prize! (read more)
GCT President, Dr. Jeffrey Apter spoke at the conference organized by Global Alzheimer’s Platform Foundation (GAP) and gave an interview about brain health to Tony Dearing. (read more)
Dr. Jeffrey Apter also talked about his experience conducting clinical studies in Eastern Europe during Kiev Clinical Trials Forum 2019 (read more).
Nataliya Katsnelson, Director of Business Development spoke with the Global Business Reports about the benefits of conducting clinical research in the USA and abroad and the recent changes in the industry. (read more)
We had a week of exhibiting at the 25th White Nights Ophthalmology Congress in St. Petersburg. (read more)
US-based Business Development team ran a Turkey Trot to kick-off the Thanksgiving celebration. (read more)
It did not stop there… If you would like to learn more about the receptions, conferences and other important updates for 2019, do not hesitate to visit and follow us on social media:
- GCTrials on LinkedIn (click here)
- GCTrials on Facebook (click here)
- GCTrials on Instagram (click here)
See you in 2020!