September: Blood Cancer Awareness Month

There are three major types of blood cancer: leukemia, lymphoma and multiple myeloma.

Blood cancer is rare and hard to diagnose. This is why many patients are left untreated during early stages of the disease. Symptoms may include: chest pain, fever, frequent infections and overall weakness.

Yearly, about 1 000 000 people worldwide are diagnosed with blood cancer.

Global Clinical Trials has successfully conducted several Phase II and Phase III studies in Lymphoma, and is familiar with the challenges blood cancer poses. We would like to use this opportunity to spread awareness about this group of diseases, and we hope that the diagnosis and treatments methods become more effective and precise very soon.

 

GCT at NYC Medical Technology Forum

Thursday, September 12th GCT Business Development team represented by Nataliya Katsnelson, BD Director and Elizaveta Medvedeva, BD Associate had a pleasure of participating in the NYC MedTech Forum. The presentations by the key speakers on the new NASH treatment method by Enzychem Lifesciences, Neuroimaging methods in detecting Alzheimer’s Disease by Frank A. Provenzano, and Hospital sequencing-based solutions by Biotia were mind-blowing. The forum was also a wonderful opportunity to connect with fellow professionals in the industry.

We are looking forward to the next year’s event!

Happy Birthday to Anna Tkachenko!

Wishing a happy belated birthday to Anna Tkachenko, GCT Chief Accountant in Russia. Thank you for being such a positive and open person and making every day at the office even brighter! We hope you have a wonderful day and a great year ahead!

GCT President, Dr. Apter at ECNP congress

GCT President, Dr. Jeffrey Apter attended the 32nd ECNP Congress, which took place in Copenhagen, September 7-10. It brought together neuroscientists, psychiatrists and neurologists from all over the world providing them with an opportunity to connect. Various topics of brain research were discussed at the conference including the progress in treatment development for brain disorders.  This was a fruitful and delightful event and a great space to share knowledge and expertise.

 

MOH approval received for Rare Genetic Disorder study in Russia

The regulatory approval to conduct CNS Pediatric study in Russia was received by GCT in under 60 days.

This Phase III study in children and young adults with a rare genetic mutation in the X-chromosome was awarded to GCT earlier this year. Study aims to recruit up to 20 patients with this rare and debilitating disease in Russia alone. GCT is responsible for the site management, providing the full service clinical operations support, logistics and regulatory services.

On average, regulatory approval in Russia may take 3 – 3,5 months. We look forward to the first site initiation for this significant and exciting project.

Happy Birthday to Dr. Sahoo

 

Today we are celebrating the birthday of Dr. Umakanta Sahoo, GCT Managing Director in India. Dr. Sahoo has more than 20 years of experience in the industry, and we are absolute thrilled to have him on GCT team since 2017. His knowledge, competence and enthusiasm contribute to the company’s success with local and global projects.

We wish Dr. Sahoo a wonderful day, a productive year and the achievement of all his goals.

 

 

Happy Birthday to Maria Voynova!

Happy Birthday to our CRA, Maria Voynova! Maria joined GCT last year in July, and it has been such a pleasure having her on team since.

Wishing Maria a wonderful day, and may this year be filled with many great moments and new successes!

New office in Poland

As our coverage grows and our local teams expand, Global Clinical Trials office in Poland has moved to a new, larger location on Wednesday, 28th of August 2019.

The new address in Poland is:

Mlądzka 10, 04-136

Warsaw

We look forward to new changes and congratulate our colleagues in Poland on the exciting news!

Phase II gastroenterology global study expansion to Ukraine and Russia

GCT has been awarded a new major project by Kangen Pharmaceuticals – a Phase II parallel-group dose-ranging study to evaluate the safety and efficacy of the drug compared to placebo in patients with chronic pancreatitis. Being the experts in the Eastern Europe for 17 years, our team will be responsible for handling the full range of regulatory activities and regional project management in Russia and Ukraine.

In order to enhance the enrollment and to keep up with the Sponsor’s timelines in the US-based study, GCT has conducted feasibility and offered a strategy to facilitate the recruitment of 164 patients.

 

 

Happy Birthday to Alina Mitrofanenko!

Wishing a Happy Birthday to our Project Manager, Alina Mitrofanenko! Alina is an extremely dedicated and loyal professional as well as a wonderful colleague to all of us here at GCT. By the vote of the entire company, she became “the best employee of the year” numerous times in a row. We feel lucky to celebrate together with Alina today at the Russian office, and hope this year brings her a lot of joy and many precious memories!

Happy Birthday to Sergiy Nayda

We would like to wish a Happy Birthday to our wonderful and dedicated colleague, Sergiy Nayda. Sergiy is our Seniour Clinical Research Associate at the Ukrainian office. All of us here at GCT are extremely proud and delighted to have him on our team for 11 years now.  Keep up the good work, and may this year bring you even more success, luck and fulfillment!

 

Keeping up with the latest trends in clinical trials

The clinical trial industry is developing rapidly and also is making great progress towards optimization of data collection and management. GCT is compliant and completely up to date with all of the recent trends. We commit to keeping pace with significant updates in technology and to adapting new e-solutions so we can offer the best quality services to our clients.

The recent report published by Veeva confirms the tendency and presents the data in regard to the unifying of clinical systems. The vast majority of Sponsors and CROs utilize eClinical applications (EDC (88%), eTMF (69%), and CTMS (61%)). While appreciating the convenience these technologies offer, most respondents acknowledge the need to improve and to unify them. According to the survey in the report, some of the major aspects that need further development include new methods of information exchange and the use of CTMS in clinical operations.

More useful data are available in the Veeva report: https://www.veeva.com/wp-content/uploads/2018/06/Veeva_2018_Unified_Clinical_Operations_Survey_Report.pdf

 

 

 

August is the National Immunization Month

Vaccination is proven to eliminate or reduce the risk of becoming infected with diseases such as hepatitis A and B, varicella (chicken pox), diphtheria, measles, polio and many more. WHO estimates that vaccination prevents 2 to 3 million deaths every year.

Despite the rumors and fake news around them, vaccines are 100% safe. They go through the multiple-step process of thorough testing before becoming available to the public, and they keep being tested afterwards.

Today we were able to significantly lower the number of infectious diseases around the world due to immunization. When considering getting vaccinated, remember: immunization not only protects you, but it also keeps people you care about safe.

Happy Birthday Natalia Krupina!

Today GCT office celebrated birthday of our wonderful colleague, Financial Manager,  Natalia Krupina. Dear Natalia, we appreciate your accurateness, and the ability to confront complex tasks head-on. Having you at our company is a great gain! Today, we want to take the privilege of wishing you all the happiness and good luck!

GCT Reception at AAIC’19

GCT President, Dr. Jeffrey Apter hosted a reception during the AAIC 2019 that took place in Los Angeles this year. The event offered an opportunity to further discuss the trends in the dementia science research development while enjoying the panoramic views of Los Angeles from the 15th floor roof terrace in the heart of the city. The evening was a delight and a great chance to reconnect with fellow professionals.

Recent CNS Studies show higher Placebo Response in the U.S.

The 2nd Annual NPD summit was held in Boston, July 23-25. The major topic was the high placebo response rates in the U.S. population compared to the Eastern European population in Schizophrenia and Bipolar studies.

Recently, Intra-Cellular ran two identical studies in Bipolar Depression. The 401 trial was entirely conducted in the U.S. and did not meet the primary endpoints due to the high rate of placebo response. Intra-Cellular announced the positive top-line results with significantly lower placebo response rate for the 404 trial, which was conducted globally with the majority of patients recruited in the Eastern Europe.

Another global study in Schizophrenia was conducted by ACADIA Pharmaceuticals and showed consistent improvement in psychotic syndromes, despite the fact that it failed to meet the primary endpoints. However, the analysis done by region showed consistent positive results for the European population including patients from Bulgaria, Czechia, Hungary, Poland, Serbia, Ukraine and Russian Federation.

Image Attribution: Elaine and Arthur Shapiro [Public domain]

Night of Networking at the annual BioCruise

Last Thursday Nataliya Katsnelson set sail with @BioNJ and @NewYorkBIO. Despite the gloomy weather, the event was a great success giving the pharma and biotech community a perfect opportunity to connect while enjoying the iconic views of New York City.

We already look forward to the next year’s event!

July is UV Safety Month

July is the UV Safety Month. We would like to use this opportunity and share some information and tips on how to be sun smart.

“Overexposure to sunlight is widely accepted as the underlying cause for harmful effects on the skin, eye and possibly the immune system. Beyond the discomfort of sunburn, tourists are also at particular risk of long-term health effects, especially skin ageing and skin cancer.” –  (WHO)

The best way to keep yourself safe against the dangerous radiation is to wear protective clothing. Give preference to thick materials and darker colors, and do not forget about sunglasses (with UV protection!) and wide brim hats. Try to avoid being under direct sunlight between 11 am and 4 pm on a hot sunny day.

To be safe from UV radiation, it is advised to use sunscreen all year long, even when it is cold and cloudy. Sun protection comes in many forms such as creams, lotions and sprays. All of the topical products are proven effective, but you should choose the ones that are at least SPF 30.  It is also important to apply the product in thick layers and to reapply it every two hours, especially after being in contact with water.

We encourage you to take steps and protect yourself so you can enjoy the sun in a healthy way!

GCT President, Dr. Jeffrey Apter at AAIC’19

GCT President, Dr. Apter is currently attending the annual Alzheimer’s Association International Conference.

The event takes place in Los Angeles 14-18 of July. AAIC is devoted to sharing knowledge and discussing the progress in dementia science, including the latest advances in prevention, diagnosis and treatment of Alzheimer’s disease. The conference also provides its attendees with great networking opportunities among the top professionals in the CNS field.

If you would like to schedule a meeting with Dr. Apter, please contact us at bd@gctrials.com.

 

Happy 4th of July!

Happy Independence Day!

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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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