PHUSE EU Connect creates a space for global professionals from across the clinical data science industry to unite, explore and train through its trademark inspirational content and networking opportunities.



We’d like to thank PHUSE for putting on another incredible event in Belfast, Northern Ireland, and to our team in Ukraine for your tremendous support. Our time at the conference was met with many positive meetings and conversations! It was great to see everyone face-to-face during the first in-person event after COVID.



Looking forward to seeing everyone at PHUSE US Connect Conference in March 2023 in our hometown of Orlando!



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Presentation



“The Trimmed Mean Approach was first introduced by Permutt and Li in 2017 and generally deals with patient dropouts in clinical trials.



During the 2022 PHUSE EU Connect in Belfast, Northern Ireland, Kateryna Fedoryshyna, delivered her presentation, “Trimmed Mean Analysis is Not Rocket Science” to a group of attendees of the conference, the first in-person event PHUSE has held in Europe since the 2020 pandemic.



Kateryna, a Lead Statistical Programmer/Analyst out of Intego Clinical’s Orlando office, aimed to provide the information of the step-by-step algorithm for a trimmed mean approach to show that once the task is divided into small steps, you clearly see how the specific analysis described in SAP should be programmed.



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When to Follow the Trimmed Mean Approach



While participating in clinical trials patients might have intercurrent events (ICE). There are different strategies described in the ICH E9 addendum that can be used to reflect intercurrent events. When you have a continuous endpoint, it’s not obvious which value one should assign to patients who experienced ICE, which is when you need to follow the Trimmed Means Approach.

PHUSE EU Connect creates a space for global professionals from across the clinical data science industry to unite, explore and train through its trademark inspirational content and networking opportunities. We’d like to thank PHUSE for putting on another incredible event in Belfast, Northern Ireland, and to our team in Ukraine for your tremendous support. Our […]

PHUSE EU Connect 2022 Conference in Belfast

In a recent article published by Karazin University, Intego Group CEO, Sergey Glushakov, and the Dean of the School of Mathematics and Informatics, Grigory Zholtkevich, were interviewed to discuss the certificate program in biostatistics, it’s graduates, and how the war has influenced the educational process.



<h2>How to jumpstart a successful career in biostatistics: a unique training program that has been running for 10 years</h2>



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Biostatistics integrates the medical field with math, statistics, and life science to drive clinical research and new drug development. The training program provided in partnership between the School of Mathematics and Informatics at Karazin National University and Intego Group, a global CRO and technology consulting company, gives students the opportunity to explore modern statistical and programming tools used for analyzing clinical trial data. The program has been designed to meet the growing needs of leading pharmaceutical and life science companies. Although Ukraine has many highly skilled IT specialists, the number of available professionals who fit the standards required by the pharma industry doesn’t cover the market’s rapid growth. That’s why, in April 2013, Karazin National University and Intego Group partnered to create a program that prepares talent who can deliver the best practices in the industry. This certificate program has been running with no interruptions since its inception and is now taking applications from around the country and admitting its tenth class of students.



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Sergey Glushakov, Intego Group



Why was Karazin National University chosen for The Center for Biostatistical Programming?



It was the obvious and straightforward choice for us and our partners. With over 35 schools and departments, Karazin National University is one of the oldest and most reputable educational institutions in Eastern Europe. Our program originally targeted students with a strong background in applied mathematics from the School of Mathematics and Informatics only, but it has since been opened up to a much broader audience from all over Ukraine. We engage professors from a number of schools within the University ecosystem. Thus, we work with the School of Medicine for life science-related courses and call on the School of Foreign Languages to handle English proficiency. Karazin National University was an obvious choice as a one-stop- shop with all the components integrated into a complex curriculum.



What’s the reason for the increased demand for professionals in biostatistics?



The industry of clinical research has been growing for decades. A global pandemic, an aging population, and various other reasons have driven investment in new drugs, medical devices, and pharmaceutical products. Looking at the official data from clinicaltrials.gov, we see exponential growth in the number of clinical trials performed worldwide. And when we look at these charts, we see a large volume of clinical data that needs to be analyzed. That’s where we’ve targeted our training so our graduates can build successful, well-paid and long-lasting careers making an impact on the global society.



How is the educational process structured?



Classes start in mid-October and run through June, when certification and graduation occur. The two-semester program is fully sponsored by our company but requires students to dedicate at least 15-18 hours a week to their studies. Those selected will learn advanced methods of statistical analysis, SAS® programming, fundamentals of clinical research, and specifics of clinical data. Since the majority of educational materials are available in English only, we’ve also integrated English language classes into the curriculum to ensure a thorough understanding and the ability to communicate at all organizational levels upon completion. At the end of the program, students must proceed with the SAS® Certification exam, in order to procure employment.



The war in Ukraine. How did it influence the program, education process and the students?



In mid-March, just a few weeks after the war began, our students were still committed to completing their studies and asked to resume classes. To many of them, this program gave them hope and a sense of purpose. At this critical moment, they all are heroes to me – the students, professors, and our senior professionals – everyone involved in the curriculum. The class of 2022 graduated from the program in June and everyone who successfully passed the SAS® certification exam was accepted to a paid internship in our company. They are undergoing additional training now and will soon be placed on various projects and clinical studies.



Why do you think students should apply to this program, especially today, and pursue a career in biostatistics?



The demand for specialists is here and will continue to grow in the years ahead. The reputation that biostatistical programmers have built in the industry will drive interest and desire to work with Ukraine. And most importantly, our professionals truly deserved the trust to handle the most critical clinical studies and keep project work going despite the war in our home country of Ukraine. The next chapter of this great story is about to begin and we’re welcoming new applicants to join the class of 2023.



 
For Karazin University’s full interview with Sergey Glushakov and Grigory Zholtkevich, go to <a href="https://karazin.ua/en/news/yak-rozpochaty-uspishnu-karieru-v-biostatystytsi-unikalna-n/" class="link">https://karazin.ua/en/news/yak-rozpochaty-uspishnu-karieru-v-biostatystytsi-unikalna-n/</a>

In a recent article published by Karazin University, Intego Group CEO, Sergey Glushakov, and the Dean of the School of Mathematics and Informatics, Grigory Zholtkevich, were interviewed to discuss the certificate program in biostatistics, it’s graduates, and how the war has influenced the educational process. How to jumpstart a successful career in biostatistics: a unique […]

Article from Karazin University Highlights the Positive Impact of Intego Group’s Biostatistics Program

On September 12th, <a href="https://www.linkedin.com/in/sergeyglushakov/" class="link">Sergey Glushakov</a>, CEO of Intego Group, delivered a presentation on the potential of Ukraine in Clinical Data Management at the SCDM 2022 annual conference in San Antonio.



With a strong medical education system in Ukraine, Sergey’s presentation focused on the potential the country has to become a key player in the field of Clinical Data Management, targeting international clinical research organizations and life science companies worldwide.



While the country as a whole has a shortage of specialized clinical data management (CDMs) professionals, Intego Group provides an in-house training program that has deepened the pool of available candidates.



Having a strong medical education system and established IT outsourcing industry, Sergey shared how developing a pool of talented clinical data managers within Ukraine serving international clinical research organizations (CROs) and life science companies worldwide is a feasible goal.



Presentation at SCDM 2022: The Untapped Potential of Clinical Data Management in Ukraine: A Novel Training Program Case Study Sergey’s presentation was based on the article published in the JSCDM journal. You can view or download the article here – <a href="https://www.jscdm.org/article/id/43/" class="link">View/download article</a>



<a href="https://www.jscdm.org/" class="link">The Journal of the Society for Clinical Data Management</a>, (JSCDM) is the society’s open access, peer-reviewed publication. The mission of JSCDM is to promote and publish scholarly work with direct relevance to the practice of Informatics and Data Science in clinical research



The <a href="https://scdm.org/" class="link">Society for Clinical Data Management (SCDM)</a> is a non-profit, international organization whose mission is to connect and inspire professionals who are managing global health data with global education, certification and advocacy.



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On September 12th, Sergey Glushakov, CEO of Intego Group, delivered a presentation on the potential of Ukraine in Clinical Data Management at the SCDM 2022 annual conference in San Antonio. With a strong medical education system in Ukraine, Sergey’s presentation focused on the potential the country has to become a key player in the field […]

Intego Insights

PHUSE EU Connect 2022 Conference in Belfast

Article from Karazin University Highlights the Positive Impact of Intego Group’s Biostatistics Program

Ukraine Seen as Untapped Potential for Clinical Data Management at SCDM 2022