Lessons Learned in 20 Years

Business is Pursuing Opportunities

Every step forward GCT has ever taken was due to a potential opportunity. Sometimes we seize the moment, and sometimes we create it. We found that staying open-minded to new ideas from both outside the company and from our own employees is key to success.

The same we offer to our clients – an opportunity to connect, share our values and strive to achieve the common goal: safer and more effective medications.

Value Quality

Be it a large global study or a stand-alone service, attention to detail and diligence are two necessities for long-term success. GCT sticks to this rule, even If it takes going an extra mile to produce the greatest result.

GCT has been on the market for 20 years now, and 80% of our projects are repeat business. This is something we are extremely proud of.

Employee Story: Csilla Léka

When did you join GCT and how long have you been at the company for? Which office are you located at?

I have joined GCT in 2016 by establishing the Hungarian office responsible for activities in Slovakia and Czech Republic too.

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

The job was much more complex than I expected but fulfilling. To be the head of the office and building the team, in addition to the project management became an important part of my daily activities.

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

The company became larger, with offices in Poland, Lithuania, Kazakhstan, Georgia and India. The team is also growing, and we have a bigger group of specialists available.

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

It is important, that we work in a supportive, friendly environment. Everyone’s contribution to the steps of global project management is valued and appreciated.

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

I remember the first investigator meeting, which I was appointed to lead. It was organized perfectly by our team and the Investigators appreciated learning and face to face interactions with Sponsor and GCT.

What have you learnt working at GCT?

I have learned, that with a talented team and supportive environment we can build and run global projects in a comfortable way, meeting specific timelines and goals.

What do you enjoy the most about your current role? 

I enjoy the complexity of the current projects running in multiple countries involving several parties. I also like collaborating with our young colleagues full of enthusiasm and with a fresh attitude.

From your point of view, what does GCT contribution to people’s lives look like? What is the most relevant thing that we do? 

We are looking for innovative solutions to make people’s lives easier, maintain health for longer, to be able to live a full life.

What motivates you to come to work each day?

I always look at the next steps to move forward in order to have the project or company reach their goals. This motivates me every day.

What are some of your favorite activities outside of work? 

Outside of work I like to spend my time active: hiking in summer, skiing in winter. I also like to read good novels.

Happy Birthday, Anton Romanov!

December is generous with birthday at GCT, and today we are celebrating one of Anton Romanov. Having worked at the company for many years, Anton has truly become an invaluable part of the team. He is great support to all his colleagues, always ready to offer a hand.

Happy Birthday, Anton! Wishing you a year full of laughter and happiness! 🙂

Employee story: https://gctrials.com/posts/celebrating-20-years-in-clinical-research-2/

Happy Birthday, Anita Bereczki!

Last Friday we celebrated the birthday of Anita Bereczki. Anita is a CRA at our Hungarian office, and has been with the company for over 3 years.

We are so happy to have Anita as part of our global team. Wishing her a wonderful and productive year ahead!

GCT Opens New Warehouse Facility

GCT has just opened a new, GMP, GDP, FDA, EMA, and Russian national regulations -compliant pharmaceutical warehouse in St. Petersburg, Russia.

It has passed a thorough state inspection and received a license to store registered drugs and medicinal products.

The facility is a newly refurbished block of 243 m. sq. located in a 24/7 guarded logistical complex. It has a digital climate control system, digital online temperature and humidity monitoring and logging system, walk-in and stand-alone refrigerators, backup power supply, and a modern office with a digital inventory, labeling, and accountability tools. The staff is experienced and highly competent. The warehouse is ready to store and process shipments in multiple temperature regimes, including ambient, refrigerated and frozen. At GCT clinical warehouse, it is also possible to re-label IPs for clinical studies.

RA Approval for Breast Cancer Study Received

Global Clinical Trials is managing a Phase I clinical study in Breast Cancer. The project has recently been approved by the Russian Ministry of Health. This is the first drug created based on the modified oncogenic virus. Pre-clinical studies have shown that the Investigational Product is successful at eliminating cancer cells. The scientists have reason to believe it can also identify and target metastases. The drug has been developed by the Institute of Chemical Biology and Fundamental Medicine SB RAS, State Research Center of Virology and Biotechnology VECTOR in partnership with Oncostar, LLC.

During the clinical trial, it is planned to evaluate the safety, tolerability, and pharmacokinetics of the drug in patients with recurrent and/or refractory metastatic breast cancer.

GCT is providing full-service management of the project, including regulatory support, clinical site monitoring and management and the drug logistics.

“It is great excitement for us as a team to work on the break-through therapy aimed at fighting the most common type of cancer,” – said Dr. Eugene Selivra, GCT CEO.

Lessons Learned in 20 Years

Never Stop Learning

If there is a single, most important and universal piece of advice for growing businesses, it is to never stop learning. However simple it may sound; it makes the most difference and takes constant effort. The ability to learn from mistakes as well as achievements is an irreplaceable asset and the predeterminant of success.

Time Finds Success

It is time that is the best mentor to any business, and the yardstick of its success. Through learning, mistakes, failures, and successes, GCT has become the organization it is today. We are a global CRO with extensive capabilities, but more importantly – we have the trust of our long-term clients.

We are so proud to celebrate 20 years on the market with all our partners this year. It is a huge milestone made possible with continuous support from our clients and professionalism of our employees.

GCT at Virtual Clinical Trials Summit

Liza Medvedeva, GCT Manager of Business Development attended the Virtual Trials Conference which took place December 6-7 in Philadelphia, PA. The event was such a great platform bringing together experts in DCT latest technologies, NFTs and patient engagement strategies.

What a great way to sum up the innovations 2021 has brought for patients and the biopharmaceutical industry in the field of decentralized clinical trials.


GCT Director of Business Development, Aleksandr Stiblo took part in the Russian Health Care Week taking at Expocentre Fairgrounds in Moscow, Russia.

The event was abundant with shows, forums and panel discussions, which brought together many industry professionals. It was partly supported by the Russian Ministry of Health Care.

Employee Story: Alina Mitrofanenko

Which office are you located at?

My office is located in St. Petersburg, Russia

How long have you worked here? Can you talk more about your role?

I’ve been working at GCT for 12 years already. And for me this is like a long-lasting relationship that never gets boring:) I’ve joined GCT as a Manager Translator, soon after my graduation without knowing a single thing about ‘clinical trials’. Now I cannot imagine my professional life without these 2 words. To date I’m managing international clinical trial projects in different therapeutic areas for 6 years already. I was promoted recently to a new position of Director, Clinical Operations Russia and I’m looking forward to new opportunities this role brings to either of parties.

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

As I’ve never worked in Clinical trials prior to joining GCT, there were a lot of new things to learn, to understand and to cooperate with. Now I can say that it is hard to surprise me in the world of clinical trials.

What has changed at the company since you joined?

A lot to be honest… The company expanded…to new destinations…new employees…new services…new challenging projects on the edge of our abilities. GCT keeps its improvement as a Global CRO to meet the everchanging demands of the Sponsors and Regulators

What is important for you at GCT?    

There are a lot of things that can be brought here, but I would say the most important are GCT people working either miles away from each other or side by side, but still together, to achieve the common goal. They are professionals. They are team players. They are friends. They are family.

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

Actually, I have a lot of them. One of the most memorable ones was my first Investigator Meeting in St.Petersburg, organized for one of our regular Clients (US Pharma). That day I learned that GCT team can do the Investigator Meetings as well as they can do the Clinical trials 😊

What was the moment when you knew you’d made the right decision to join GCT?

In 2010 my first project after the promotion to CTA was an international multicenter CNS project led by GCT with a huge Pharma. I eagerly searched for new knowledge and wanted to be on top of every detail, studying GCP, Protocol and numerous guidelines and manuals. But in fact, the real knowledge I gained was from my study team members I’ve interacted daily for different aspects of the trial. We were a large international team of PM, CRAs, and study sites and we shared experience, thoughts, and opinions to achieve a common goal of a successful study completion.  And at that very moment I was so happy to start my career in clinical trials learning from those people in GCT, who knew exactly how to do the study well.

What do you think the mission of GCT is?

The mission of GCT I think, is obvious – to help its clients to provide medical society and patients with advanced, safe, and effective therapies.

Describe GCT in 3 words:

Hard to choose only 3 words but I will try… The 1st is Team – for the team of professionals working together towards our common success. The 2nd is Dedication – for the dedication of GCT’s people to the work they do; and the last but not least, Quality – for the quality of data GCT bring to its clients.

How do you see GCT in 10 years?

Looking back to where it all began and to where we stand right now … it’s hard to believe that 20 years ago it was a group of people who rented a small office and started to do clinical trials… first, in Russia, and then – in the US and Europe. The Company became global and independent, expanding its services, knowledge, fields of interest, reflecting the most recent realities of our life. In the next 10 years GCT should keep the pace and develop new directions. I’m sure that in 10 years, despite these changing requirements to medical society, GCT will be a big, experienced, and confident market player.

Happy Thanksgiving!

Wishing a Happy Thanksgiving to our partners and industry colleagues! We are grateful for your continuous support in drug development this and every year. 🧡

Happy Birthday to Dr. Oleg Kurilov!

Oleg Kurilov, MD, General Director of GCT Kazakhstan celebrated his birthday yesterday, November 21st. Our team wishes Dr. Kurilov further success and much happiness this year. We are proud to have such a wonderful colleague on the team!

Pancreatic Cancer Awareness Month

November is Pancreatic Cancer Awareness Month.

Symptoms of Pancreatic Cancer include:

  • Stomach pain
  • Change in stool
  • Weight loss
  • Back pain
  • Loss of appetite

If any of these symptoms are present, it is strongly recommended to speak with a medical professional as early diagnosis is crucial.

Dr. Umakanta Sahoo at CPhI India

General director of GCT India, Dr. Umakanta Sahoo is taking part in the CPhI & P-MEC India conference. The conference is gathering pharma industry professionals to discuss the latest trends in market and drug development.

The conference is held 15 – 30 November 2021 Online. Connect with us at bd@gctrials.com to schedule a meeting.

Flu Vaccine Trial in Pregnant Women Awarded

GCT has been awarded a multicenter flu vaccine clinical trial in Russia. It will be carried out with participation of approximately 500 pregnant women at screening, and with a follow-up extension to babies. GCT possesses previous experience in conducting multinational studies in pregnant women with participation of 1000+ subject.

The sponsor, one of the largest research institutes in the country set strict requirements for CRO qualification process and challenging study parameters. Hence, GCT is proud to be the only local CRO eligible for the study conduct after the public tender procedure.

“GCT possesses solid resources and proven capabilities in Russia.  We are confident to support this important study in cooperation with the client at the highest international standard of quality,” – said Dr. Eugene Selivra, GCT CEO.

The regulatory approval has already been obtained, and the study will be managed by GCT full-service onward. GCT logistics department will also support the supply and import of the comparator vaccine from oversees, utilizing the warehouse facilities owned in Russia. In order to minimize the number of onsite subject visits during COVID-19, the team considers using ePRO solutions for data collection at follow up visits.

GCT President Takes Part in CTAD Congress

Dr. Jeffrey Apter is taking part in the CTAD Alzheimer’s congress. The event is being held November 9-12 at the Boston Park Plaza. It brings together key industry professionals and Key Opinion Leaders (KOLs) in Alzheimer’s disease to discuss the latest innovations and effective treatment development.

Currently, there are a few options available to mitigate the symptoms of the disease, but no cure has been invented yet. The research is ongoing and is especially active. Dr. Jeffrey Apter is a practicing psychiatrist and a Key Opinion Leader in Alzheimer’s disease with years of research experience and multiple publications on the topic. GCT has managed numerous Alzheimer’s trials both in the US and globally.

Please reach out to us at bd@gctrials.com to request more information.

GCT to Manage Bioequivalence Study in Healthy Volunteers

Calcium channel blockers are medications used to lower blood pressure.

Last week, GCT has been selected to conduct a bioequivalence clinical trial in a calcium channel blocker, Manidipine. The randomized, two treatment, two sequence, two way cross over, bioequivalence study of Manidipine Dihydrochloride tablets will be performed in Ukraine with participation of 30 healthy volunteers.

GCT will manage the full-service study support including medical writing, clinical and medical monitoring, regulatory, project management, site and vendor management, data management and biostatistics.

“We are thrilled to enhance our cardiovascular trials portfolio in Ukraine and to build strong partnership with our new client,” – said Dr. Jeffrey Apter, GCT President.

GCT has deep experience in the management and execution of BE / BA / PK clinical trials, in Ukraine and globally.

Dr. Apter Participates in CNS Summit 2021

Dr. Jeffrey Apter at CNS Summit 2021

Dr. Jeffrey Apter, GCT President took part in the annual CNS Summit. The event took place in Boston, MA, November 7-10, and gathered researchers and industry professionals from all over the world.

The summit provided a wonderful opportunity to discuss the latest technology in CNS and neurology, clinical research in the area, regulatory issues, and financing. The participants enjoyed networking opportunities, social event and fascinating spotlight sessions.  

Employee Story: Vladimir Seredyuk

Which office are you located at?  

St. Petersburg, Russia

How long have you worked here? Can you talk more about your role?  

Since 12 May 2014. As the QA Director, I am responsible for quality of services provided and qualification & training of personnel at the company.

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

The job was exactly what I expected. I had an excellent opportunity for quick professional development at the company.

What has changed at the company since you joined?

There were operational offices just in four countries and now there are 11 offices in different parts or the World.

What is important for you at GCT?    

Teamwork, support from the colleagues and their extreme motivation to be successful.

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

Conducting investigational site audits for the project in 4 countries: Bulgaria, Romania, Russia and Ukraine.

What was the moment when you knew you’d made the right decision to join GCT?  

This was approximately a month after joining the company when the first project started with a very important medicine for multiple sclerosis.

What do you think the mission of GCT is?

To make life of people better by taking the lead in development of new medicines for them.

Describe GCT in 3 words

Highly competitive professionals

How do you see GCT in 10 years?

I see GCT as a constantly growing organization with at least 20 offices worldwide.

Alzheimer’s Disease Awareness Month

 Beta-amyloid protein disrupting nerve cells function in a brain with Alzheimer’s disease

In November, we are spreading awareness about the devastating Alzheimer’s Disease. Alzheimer’s Disease often creeps up unnoticeably with symptoms worsening gradually over time. It mostly affects the older population; however, it can also start as early as in the person’s 40s or 50s. AD is the most widespread form of Dementia impacting both short- and long-term memory, thinking ability, mood and behavior.

Medication and therapy are available to treat some of the symptoms and to slow down cognitive decline. Even though no cure exists for AD, the research is ongoing actively.

GCT is a CNS & Neurology focused CRO with Dr. Jeffrey Apter, a Key Opinion Leader (KOL) in Alzheimer’s Disease as the president of the company. Please reach out to us at bd@gctrials.com to find out about our experience in AD trials and / or to request a quote.

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