Meet GCT at CPhI Discover 2021

GCT is taking part in CPhI Discover 2021 – a place where the industry professionals can meet, partner learn.

Aleksandr Stiblo, GCT Director of Business Development is representing GCT at the event.  

Contact us at bd@gctrials.com to schedule a virtual meeting with Aleksandr.

May is Brain Tumor Awareness Month

This month is dedicated to raising awareness of brain tumors.

A brain tumor occurs when abnormal cells form in the brain. There are two main types of tumors: cancerous (malignant) and noncancerous (benign).

Around 1.4 million patients worldwide are struggling with malignant brain tumors.

Below are the most common symptoms:

  • headaches
  • seizures (fits)
  • constant feeling of malaise (nausea), vomiting, and drowsiness
  • mental or behavioral changes such as memory problems or personality changes
  • progressive weakness or paralysis on one side of the body
  • vision or speech problems

Today new treatment technologies bring the hope of treating brain tumors more successfully.  

Lessons Learned in 20 Years

Build your business around things you are good at

Dr. Jeffrey Apter and Dr. Eugene Selivra, GCT founders, both had had solid experience in clinical research when they decided to establish a CRO. Their experience in psychiatry, interest and deep understanding of the industry was a necessary premise for success.

Dr. Apter, GCT President is a Medical Director of Princeton Medical Institutes and a Senior Attending Physician at Penn Medicine Princeton Health. Being a Key Opinion Leader (KOL) in Alzheimer’s Disease and Depression in the U.S., he continues to attend the major professional events and to see his patients. Dr. Apter has published dozens of articles in Psychiatry and Neurology.

Earlier in his career, Dr. Selivra, GCT CEO was the Head of a Geriatric Psychiatry Department at the St. Petersburg Bekhterev Psychoneurological Research Institute. The Bekhterev Institute is the oldest Russian scientific institution performing studies in neurologypsychiatry and psychology.  Also a KOL in CNS, he actively maintains professional relationships with the leading experts in the field and is closely familiar with many European CNS sites and Investigators.

For the past 20 years, both GCT founders have been providing expert oversight of CNS studies conducted by GCT.

Value connections across the industry

Establishing personal connections within the industry can end up benefiting the business in an unexpected way, even if they seem irrelevant at first.

Friendly relationships with vendors and competitors allow an exchange of useful information and resources. Being on good terms with past, current and potential sponsors establishes trust and credibility.

At the end of the day, the work environment becomes much more pleasant if it is filled with friends looking in the same direction.

Employee Story: Sergiy Nayda

  • What can you say about Ukraine’s involvement in clinical trials?

GCT founded its Ukrainian office in January 2007. Since then, Ukraine’s clinical trials industry has evolved significantly; especially its regulatory and logistics aspects. With each year, the Ukrainian regulations are becoming more harmonized with the EMEA region. It makes conducting clinical trials here simpler and more predictable for sponsors.

In the meantime, GCT team in Ukraine has been conducting trials in numerous therapeutic areas – oncology, hematology, psychiatry, ophthalmology, obstetrics and gynecology, and others. While gaining this experience, we have become well-familiar with the country’s specific regulations and have built professional relationships with the local clinical sites.

  • How long have you been with GCT?

I joined GCT in April 2008 after I had graduated from the National Medical University named after O.O. Bohomolets in Kyiv. My medical background is in anesthesiology and reanimation. My current position at GCT is Project Manager.

  • Was the job what you expected it would be? Did anything surprise you?  

I believe no one knows the world of clinical trials very well except the people who have worked in it. You start your career in clinical trials, and eventually you understand that your actual tasks will almost always exceed those in the job description. It is of a great value for me to never stop learning and to keep upgrading my skills.

  • What have changed at the company since you joined? 

GCT became a global company establishing the offices from North America to India through Europe. What is most important, besides the size, it is building our own good practice. As GCT is continuously enriching its trials’ experience, improving teamwork procedures, perfecting the SOPs, you feel accomplished working here.

  • What is important for you in GCT?     

For me personally, GCT is a big family of professional people who love to work in clinical trials reaching new milestones together as a team. You can always get support and advice from your colleagues. I also appreciate that every process, every activity we do in GCT is always transparent and clear, allowing for equal opportunities for all employees.

  • Can you describe an event that was particularly memorable during your career at GCT?

Considering the pandemic “outside” and looking on how our lifestyles and work became all virtual, I think that the in-person meetings are the highlights of my career at GCT. Especially, the Investigator Meetings where you can speak face to face with all the attendees, attend a round table, engage in curios scientific discussions and simply spend some good moments together with other people.

  • What was the moment when you knew you’d made the right decision to work here?

Since I started to work in clinical trials I have never doubted my decision.

  • What do you think the mission of GCT is?

The mission of the GCT as a global CRO is to be a part of the extremely important process of new drug development. When you see that people close to you are able to get good quality safe medication for an affordable price because of the quality work you do, it motivates you a lot.

  • Describe GCT in 3 words

GCT: Great Collaborative Team

  • How do you see GCT in 10 years?

In 10 years, I see GCT as a strong competitive global CRO with a wide range of services keeping its good values and principles of work.

Meet GCT at the World Vaccine Congress Washington 2021

Aleksandr Stiblo, GCT Business Development Director is participating in the World Vaccine Congress Washington, May 4-6.

This virtual event is the largest, most established meeting dedicated to vaccines. The keynote speakers are going to cover the most relevant topics of the 2021 year. For instance:

  • Cancer Immunotherapy
  • Immune Profiling
  • Respiratory Vaccines
  • Emerging & Infectious Diseases
  • Clinical Trials
  • Vaccine Partnerships
  • Bioprocessing & Manufacturing
  • Vaccines Safety
  • Logistics
  • Veterinary Vaccines
  • Partnerships

GCT team looks forward to taking part in networking opportunities of the WVCW. Connect with Aleksandr Stiblo if you need help with placing a clinical trial.

Oral Cancer Awareness Month

April is Oral Cancer Awareness Month.

Oral cancer is the cancer of the mouth. Mouth cancers form when cells on the lips or in the mouth develop changes (mutations) in their DNA.  With time mouth cancer cells may spread inside the mouth and on to other areas of the head and neck or other parts of the body.

Signs and symptoms of mouth cancer may include:

  • A lip or mouth sore that doesn’t heal
  • A white or reddish patch on the inside of the mouth
  • Loose teeth
  • A growth or lump inside the mouth
  • Mouth pain
  • Ear pain
  • Difficult or painful swallowing

Factors that can increase the risk of oral cancer include:

  • Tobacco use of any kind, including cigarettes, cigars, pipes, chewing tobacco, and snuff, etc.
  • Consumption of strong alcohol
  • Excessive sun exposure on the lips
  • A sexually transmitted virus called human papillomavirus (HPV).
  • Weakened immune system

VIII Global Educational Forum “Russian Cardiovascular Days”

Today GCT team was delighted to attend the VIII Global Educational Forum, “Russian Cardiovascular Days”. This event was organized with the support of the Russian Society of Cardiology, Almazov National Medical Research Centre, and ESC, Member National Cardiac Society.

Aleksandr Stiblo, Director of Business Development, and Yulia Pavlenko, Project Manager, connected with the leading Russian cardiovascular experts discussing the current issues in the cardiovascular therapeutic area.

The event covered diverse topics on acute coronary syndrome, arrhythmias, cardiovascular prevention, heart failure, and difficult clinical cases.

Contact bd@gctrials.com to find out more about GCT cardiovascular experience

Promoting the clinical trial industry among university students

Maria Kokalova, Business Development Associate, was invited to present GCT at the Bonch-Bruevich St. Petersburg State University of Telecommunications, where she graduated from.

Maria spoke about clinical research, the importance of a CRO, and her personal job responsibilities. The audience consisting of current students was eager to find out more about job opportunities at the company and in the clinical trial industry.  

April is Irritable Bowel Syndrome Awareness Month

  • What is Irritable Bowel Syndrome (IBS)?

IBS is a common condition that affects the digestive system. It causes symptoms such as stomach cramps, bloating, diarrhea, and constipation. These tend to come and go over time and can last for days, weeks, or months at a time.

  • Who is mostly affected by IBS?

People of all ages have IBS, from young children to the elderly

  • What can be done to prevent it?

There is no one diet or medication that works for everyone with IBS. However, there are a few things that could help the patients:

  1. cooking homemade meals with fresh ingredients
  2. keeping a journal of the foods consumed and any following symptoms you get
  3. exercising regularly

It is recommended that patients avoid the following:

  1. Putting off or skipping meals
  2. Eating too fast
  3. Eating a lot of fatty, spicy, or processed foods
  4. Eating more than 3 servings of fresh fruit a day
  5. Drinking more than three cups of tea or coffee a day
  6. Drink a lot of alcohol or fizzy drinks

Happy Birthday, Dmytro!

Last Saturday, Dmytro Mnozhynskyy, GCT General Director of the Ukrainian office, celebrated his birthday.

Dr. Dmytro Mnozhynskyy has been working at the Ukrainian office since its foundation in 2007, and his enthusiasm and energy never stop amazing us.

We at GCT are proud to work with such a professional on the team. Happy Belated Birthday!

GCT team at IPheB 2021

GCT Business Development team in St. Petersburg, Aleksandr Stiblo Maria Kokalova, attended the International Exhibition of Pharmaceuticals, Engineering and Biotechnology IPheb 2021.

The event was a good opportunity to initiate potential partnerships in the fast-growing pharmaceutical markets of Russia and the CIS countries.

We at GCT were happy to start participating in on-site events after a long break pursuing new opportunities in the ever-evolving world of medicine.

Fabry Disease Awareness Month

Fabry disease is a rare inherited disorder caused by a gene mutation. It narrows blood vessels, which can hurt the skin, kidneys, heart, brain, and nervous system.

Diagnosing fabry disease can be challenging. That is because the symptoms are common and can affect so many different parts of the body.

The symptoms include:

  • Chronic pain in the hands and feet;
  • Opaque corneas;
  • Hearing loss;
  • Gastrointestinal problems;

and many more.

Fabry disease is confirmed with a test measuring levels of alpha-galactosidase.  

Treatment of the disease mostly focuses on reducing the symptoms and improving the quality of life of the patient. For instance, it can be achieved via using pain relievers and anticlotting medications.

Contact bd@gctrials.com to learn about GCT’s experience in conducting clinical trials in Rare Diseases, including Fabry Disease.

Happy Birthday, Aleksandr!

Last Saturday GCT Director of Business Development, Aleksandr Stiblo, celebrated his birthday.

Starting at GCT in 2016, Alexander has become an indispensable part of our team.

Dear Aleksandr, may all your dreams come true! We at GCT are happy to have such a resourceful, professional and energetic colleague on the team. Happy birthday!

Approval for Endometriosis study in Ukraine obtained

Global Clinical Trials has been recently awarded to run a new project in Women’s Health.

A Phase III double-blind, three-arm superiority study in 200+ subjects with endometriosis will be conducted by GCT in Ukraine. The goal of the study is to assess the efficacy and safety of the Investigational Product (IP) for the treatment of endometriosis in women of reproductive age. 

On March 23rd, 2021, the State Expert Centre of MOH of Ukraine has issued approval to begin the enrollment.

Endometriosis is one of the most common diseases of the female reproductive system; when it occurs, the cells of the endometrium (the layer lining the uterus from the inside) grow outside it. Endometriosis can affect women of any age. It is a long-term condition that can have a significant impact on one’s life. Fourteenthly, nowadays there are a number of treatment options that may help.

“This project is a wonderful opportunity for GCT to use its expertise and to enhance its experience in Women’s Health trials. The team is looking forward to the next milestone,” said Dr. Eugene Selivra, GCT CEO.

Happy Birthday, Marina Milutka!

Marina Milutka, one of our newest CRAs, celebrated her birthday last Friday.

All of us at GCT are happy to welcome a new clinical professional to the team and wishing her much success and a wonderful year ahead.

Happy Birthday, Marina!

Happy Birthday, Irina Ryzhkova!

Irina Ryzhkova, GCT Deputy Director of Legal Affairs, celebrated her birthday yesterday.

We’ve been incredibly lucky to have her on the team since 2012. The combination of her heart of gold, diligence, and sincerity makes her an invaluable part of GCT.

Dear Irina, congratulations on your special day!

Happy Easter!

Wishing you a season filled with peace, joy, and beautiful weather. Happy Easter!

Employee Story: Daria Podgorska

  • Daria, being the General Director of GCT Polish office, what can you say about Poland’s involvement in clinical trials, and you experience in the country?

Our office in Warsaw operates since 2017, and I have been working in clinical trials for more than 15 years. Polish sites started participating in multinational research studies one of the first in Europe, on a par with Germany and other western European countries. Polish investigators are involved in every aspect of the trial that they take on. It has been great to see this industry maturing and institutions developing relations with the rest of the industry leaders.

  • Can you talk more about your role and background?

I’m a doctor and my specialty is neurosurgery. I have been working as a medical monitor and have established a safety and PVG department, which actively works with EMA’s Eudravigilance, and provides global safety support for the outside of EU GCT countries.

Apart from this activity, I’m managing a team of CRAs that is growing from year to year.  

  • Was the job what you expected it would be? Did anything surprise you?  

When I had joined GCT I knew very well what could be expected in clinical trials work routine, but I didn’t expect that our Polish branch could develop so quickly.  

  • What’s changed at the company since you’ve joined?  

We are now present in an increasing number of countries. It means that we are a global CRO. As I mentioned, in Poland in particular, we have developed pharmacovigilance services that are extremely important, and we provide support to all neighboring countries centrally now.

  • What is important for you in the corporate culture of GCT?

Professionalism, flexibility, and a friendly atmosphere. Being a part of the GCT team gives me the feeling that nothing is impossible.

  • Can you describe an event that was particularly memorable during your career at GCT?

Our first international investigators’ meeting that was organized in Warsaw. It was the first meeting in my career with GCT, and I wanted everything to be perfect. The team did a wonderful job and Investigators were very engaged.

  • What was the moment when you knew you had made the right decision to work here?

Probably after my first meeting with Eugene, GCT CEO. It is very important to know the people you are working with. I was able to confirm this in practice after our first study that included Poland was initiated. I know that this part of Europe has a big experience and potential in clinical trials, and our latest projects prove it.

  • What do you think the mission of GCT is?

Further development. Sometimes driven by the challenges that help us to grow, invent new technologies and solutions.

  • Where do you see GCT in 10 years?

We will continue to expand by adding new countries, while still being innovative and flexible. Knowledge of local requirements will remain our big advantage. 

Lessons Learned in 20 Years

Build a culture, then a company

A healthy and ethical workplace is very important. Creating a culture of trust and encouragement attracts the right employees and helps them work towards a common goal. These principles ultimately translate into relationships with clients – and that is invaluable for any business’ growth.

Don’t make promises in order to make a sale

Be careful in analyzing the situation and only promise what you can deliver. When a company keeps its promises, it creates a sense of trust and belonging for the client.

Dr. Jeffrey Apter, GCT president shared: “80% of GCT projects are repeat business which shows our customer’s loyalty and satisfaction with our work”.

Study in COVID-19 Patients to be Conducted by GCT

Global Clinical Trials has been awarded a Phase I study in COVID-19 patients by a U.S. sponsor. Proud to have 80% of the projects as repeat business, GCT is currently collaborating with the sponsor on another clinical trial in the U.S.

The Investigational Medicinal Product (IMP) is designed to ease the symptoms and reduce SAR COVID-19 viral load. The study will be performed in 30 patients at 2 sites in the U.S.

GCT is proving full-service support for the trial, including project and site management, medical writing, data management and biostatistics. The team is looking forward to the prompt start of the activities.

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GCT is a CRO experienced in performing clinical research in the USA, Europe, Russia and India.

We are a full-service clinical development provider, offering feasibility analysis, regulatory submission, site selection, project management, monitoring, data management, logistics, and more.

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