Happy International Women’s Day

Congratulating all the wonderful women around the world and our own GCT team with this special holiday!

Dr. Jeffrey Apter at ISCTM

Dr. Jeffrey Apter participated at the 16th Annual Scientific Meeting organized by ISCTM that took place on the 19-21 February 2020. As always, it was a great opportunity to discuss the latest innovations in the CNS clinical trials with the industry colleagues.

Happy Birthday to Valeria Paramonova

Happy Birthday to our Clinical Trial Assistant, Valeria Paramonova! She has been working at the GCT Russian office in St. Petersburg since July of last year, and is a valuable addition to our global team. We are wishing Valeria a wonderful day and for all her dreams to come true!

Endometriosis Awareness Week 2020

It is the Endometriosis Awareness Week, and as GCT initiates a new study in the indication, we are glad to see that this condition receives more and more attention with each year, and it is an honor to contribute to raising awareness.

The condition of endometriosis occurs in women when the cells similar to the tissue normally covering the inside of the uterus, grow outside of it. While the causes remain unknown, the symptoms often include pelvic pain, heavy menstrual bleeding and pain while urinating. However, the absence of obvious symptoms is also common. Thus, medical imaging and tissue biopsy are usually necessary to diagnose this condition. While a few treatment options are available to ease the symptoms, many pharmaceutical companies are currently looking to develop new innovative and more effective medical products.

Though, the condition is invisible, it affects 1 in 10 women and causes them to suffer from pain daily. It can also lead to infertility. Worse yet, the diagnosis of the disease often takes 5+ years, as it is often confused with many other conditions.

Rare Disease Day 2020

Each year last day of February is marked as the Rare Disease Day. It is a great and a very meaningful opportunity to raise awareness about conditions that are rare i.e. affect fewer than 1 in 1,500 people in the United States or fewer than 1 in 2,000 people in the EU. Nevertheless, they are no less important.

GCT has contributed to the development of a number medical products for rare diseases and orphan drugs in hematology, dermatology, rare CNS indications, genetic disorders, respiratory, metabolic, cancer etc. Currently, we are conducting a pediatric study in patients with a rare neurological disorder. All of us at GCT look forward to seeing the positive impact of the drug on the young patients that participate in the trial and on their families.

New OB/GYN Study in Ukraine

GCT has been awarded a new randomized, double-blind, three-arm, parallel-group, multicenter superiority study in Ukraine. The goal of the trial is to assess the efficacy and safety of the drug in women suffering from endometriosis. This is a global study currently run in more than 5 countries. In Ukraine alone GCT will enroll 150 patients at 11 investigational sites.

For this project, GCT is responsible for the wide range of services including the regulatory support, site management, remote and on-site monitoring and the full cycle logistics management of the IMP, lab kits and biosamples. The project lead in Ukraine is Dmytro Mnozhynskyy, MD; he has more than 15 years of experience in clinical trials. Having successfully managed numerous women’s health clinical trials, GCT will transfer the accumulated expertise for the smooth and timely study completion.

Eating Disorders Awareness Week 2020

11th SCOPE Summit

This week, Nataliya Katsnelson, our BD Senior Director attended the fruitful SCOPE Summit in Orlando, FL. The conference was a perfect place for meeting new potential costumers, reconnecting with our clients and sharing the industry insights among the fellow professionals.

Happy Birthday, Elizaveta!

Elizaveta Medvedeva, BD Associate, celebrates her birthday at GCT office in Russia

This wonderful February day, GCT BD Department feels especially festive as we are celebrating birthday of Elizaveta Medvedeva, our newest BD Associate. She joined company in 2018 and became a valued member and contributor to the global team work ever since.

We wish for your life to be filled with joy, travel and meaningful goals. May today and all your days be amazing!

17 February: Presidents’ Day

Wishing everyone a happy Presidents’ Day today!

Anna Florczak’s Birthday

Yesterday we celebrated the Birthday of Anna Florczak, GCT CRA and Safety Specialist in Poland. Anna joined our company in 2018 as Research Assistant, and has been contributing her expertise and professionalism to our global team’s work since.

Dear Anna, we hope you had a wonderful day celebrating and wish you all the best for your birthday!

February 12th: Sexual and Reproductive Health Awareness Day

On SRH Day we are aiming to increase awareness on sexual education and reproductive health – an issue important for both men and women. We urge everyone to become more knowledgeable about the topics such as puberty, contraception, pregnancy, abortion, and STIs. Having knowledge on the matter lowers the chances of getting infected, which may lead to future dysfunction or even infertility. Moreover, it ensures a higher quality of life, emotional and physical health.

GCT has managed many clinical studies in obstetrics and women’s health, as well as in men’s reproductive health. Please do not hesitate to get in touch with us for more information or to request a feasibility analysis for your study.

Today is World Cancer Awareness Day!

Happy Birthday to GCT CEO

We are celebrating the Birthday of Dr. Eugene Selivra, GCT CEO today!

All of us here at Global Clinical Trials feel beyond grateful to work in such a diverse and global, yet family-like environment.

We wish Dr. Selivra a wonderful and successful year ahead and plenty new and exciting projects. Thank you you for setting an example of dedication and passion for work.

Happy Birthday!

-GCT Team

GCT Expands Operations to Kazakhstan

Oleg Kurilov, MD – GCT General Director in Kazakhstan

As 2020 begins, GCT expands its operations in Asia, adding the Republic of Kazakhstan to its map. Dr. Oleg Kurilov is appointed the GCT General Director in Kazakhstan. He specializes in surgery, urology and nephrology and has a broad expertise working in clinical trials.

Located in Central Asia, Kazakhstan has a population of over 18 million people. It is the world’s largest landlocked country and the ninth largest country in the world. Kazakhstan is part of The Eurasian Economic Union (EAEU). Among many economic and political areas, the union regulates and unifies the pharmaceutical and clinical trials industry. This includes an easier registration of drugs and medical devices, accelerated approval timelines, and a simplified customs and logistics process in other member countries. These advantages make Kazakhstan attractive for both regional and global companies.

In December 2019, the government of Kazakhstan approved the state program for the development and improvement of the country’s Healthcare System for 2020-2050. A significant part of the program is devoted to increasing the number of clinical trials and bringing international clinical trials into the country. Currently, it takes 1 month to receive the approval for a clinical study from the Regulatory Authority. The submission to the Ethics Committee is performed in parallel. This allows study sites to open in just 1.5 months, providing no questions are raised by either authority. It is also worth to mention that all regulatory documentation can be submitted in the Russian language.

“Providing the high quality clinical trial services is always our top priority, and expanding to new regions enhances our operational capabilities. Kazakhstan is a rapidly developing country that is fully compliant with GCP. It is a great option to consider Kazakhstan for a global study to have a diverse patient population and fast enrollment. We are excited to offer this new region to our clients,” – GCT CEO, Dr. Eugene Selivra.

GCT Team at ISCR 2020

Last week for the 13th time Indian Society for Clinical Research (ISCR) conference took place in Mumbai.The event brings together main influencers of the Indian clinical research society, as well as unites the industry professionals from around the globe. Dr. Eugene Selivra and Nataliya Katsnelson together with the GCT Managing Director, Dr. Umakanta Sahoo participated at this annual conference to discuss new regulations, and how technology meets clinical research assuring the ultimate goal of enhancing patient’s safety.

Visit to Office in Mumbai

Due to the team growth and services extension of GCT India, we moved to a new office in Mumbai at end of 2019. While participating at the international conference, CEO, Eugene Selivra, MD and Senior Director of Business Development, Nataliya Katsnelson visited the new facility in one of Mumbai’s business centers.

End of Enrollment for Pediatric Phase III Trial

GCT has successfully concluded enrollment for the Phase III pediatric study of rare neurological disease in Russia. Reaching the exact recruitment number, as predicted and in under 1.5 months marks an important milestone for our company and the Sponsor – US Pharma and GCT long term partner. Together, we were able to meet the projected deliverables despite the demanding timelines, sensitive patient group and limited number of sites that treat this devastating condition in Russia. The treatment phase of the study is now well underway according to the protocol schedule.

Meet GCT at ISCR Summit

Meet GCT team at the ISCR Conference next week in Mumbai! – https://www.iscr.org/iscr-conference-2020/

January, 24-25, GCT CEO, Dr. Eugene Selivra, Country Director, Dr. Umakanta Sahoo and Senior Director of Business Development, Nataliya Katsnelson will be at the summit, which is devoted to bringing together the global and local clinical research community.

To schedule a meeting, please contact us at BD@GCTRIALS.COM.

We look forward to seeing you there!

Thyroid Awareness Month

The thyroid gland is a gland located in the lower front of the neck. It produces thyroid hormones, which are then secreted into the blood and transferred around the body. These hormones are responsible for coordinating many important processes within the body, for example, controlling the body temperature and heart beat.  Hence, when the thyroid gland doesn’t function properly, it can result in serious conditions.

The two main types of conditions are Hyperthyroidism and Hypothyroidism. When they occur, the thyroid gland produces too much and too little hormones, accordingly. However the symptoms can be vague – weight loss/gain, depression and fatigue.  It is necessary to take a blood test in order to understand how well a thyroid gland works. If a dysfunction is detected, there are a few treatment options available from medications to surgery.

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