The world of clinical research is driven by visionaries who strive to bridge the gap between scientific innovation and patient care. In Europe, these pioneers are reshaping the industry of drug development and medical device testing, raising the bar of what is possible in healthcare. As regulatory frameworks evolve and patient-centric approaches gain prominence, the role of Clinical Research Organizations (CROs) has become more crucial than ever in navigating the complex journey from laboratory to bedside.
Leading this dynamic field is Dr. Kornelia Szasz MD. DESA, CEO of Szasz&Co. Bt., a boutique CRO located in Hungary. With a rich background in medicine and anesthesiology, Dr. Szasz has transformed her passion for improving patient outcomes into a mission to revolutionize clinical research. Her journey from practicing physician to CRO leader exemplifies the interdisciplinary expertise needed to tackle the challenges of modern drug development and clinical trials.
Under Dr. Szasz’s leadership, Szasz&Co. Bt. has emerged as a signal of innovation in the European CRO sector. The company’s focus on early-phase trials and its dedication to supporting small to midsize sponsors and start-ups set it apart in a competitive industry. By combining medical acumen with a deep understanding of regulatory complexities, Dr. Szasz and her team are not just conducting trials; they’re shaping the future of healthcare. Their work embodies the spirit of collaboration and innovation that is driving the next generation of medical breakthroughs across Europe.
Let’s dive into the interview details below!
Could you please provide a brief overview of your company, Szasz&Co. Bt., and its core services in the field of CROs in Europe?
Szasz&Co. Bt. has been established in 1999. Initially, our primary focus was providing medical services in pediatrics, anesthesiology, and intensive care. Since 2020, we have expanded to operate Szasz CRO, a boutique clinical research organization dedicated to supporting pharmaceutical and medical device companies in successfully conducting their clinical trials in Hungary and Europe. We offer a comprehensive range of clinical research services, including planning and managing trials from the selection of participating countries and centers, regulatory affairs and obtaining necessary approvals, to initiating, monitoring, and closing clinical trials. We also provide vendor management services.
What inspired you to establish Szasz CRO and what were the initial challenges you faced in the highly competitive CRO industry?
After several years in the pharmaceutical industry and clinical research, gaining extensive experience in site management, project management, and quality assurance with Szasz&Co. Bt., I recognized a need for a boutique CRO to manage early-phase clinical trials for small to midsize sponsors and start-up companies in early development. Szasz CRO aims to fulfill this need by providing specialized services as a boutique clinical research organization.
As the CEO of a CRO in Europe, what are the key strategies you have implemented to enhance the efficiency and quality of clinical trials while ensuring compliance with regulatory requirements?
Our philosophy and key strategies for enhancing the efficiency and quality of clinical trials while ensuring regulatory compliance include the following: Our CRO is founded by experts and top professionals in medicine and clinical research. We adhere to the highest quality standards, and through continuous training, we keep our knowledge up-to-date with current regulations and fundamental principles.
With the increasing emphasis on patient-centric approaches in healthcare, how does Szasz&Co. Bt. incorporate patient perspectives and experiences into the clinical trial process?
Szasz&Co. Bt. provides special care for study participants by implementing enhanced safety measures and ensuring that patients at study sites receive the highest level of care.
What are your thoughts on the role of digital technologies, such as telemedicine and remote monitoring, in streamlining clinical trials and improving patient engagement?
Implementing digital technologies, such as telemedicine and remote monitoring, in clinical trials is extremely beneficial. These technologies significantly enhance patient comfort and engagement, while also improving the efficiency and cost-effectiveness of monitoring activities. However, it is crucial to find the right balance between utilizing these new technologies and maintaining personal clinic visits and on-site monitoring.
Could you highlight some of the successful collaborations or partnerships that the company has established with pharmaceutical companies, academic institutions, or other stakeholders in the healthcare industry?
Szasz&Co. Bt. has successfully collaborated with the following sponsors and academic institutions, providing site management and project management services: Alimentiv BV., Lumenis BE Ltd, Meril Life Sciences Ltd., Semmelweis University Cardiovascular Center, and Unity Health Toronto.
Based on your extensive experience in the CRO industry, what advice would you offer to aspiring entrepreneurs or professionals seeking to make a significant impact in the field of clinical research?
My general advice is to consistently perform the highest quality work, adhering to the requirements of ICH-GCP Guidelines, international and local regulations, and the expectations of sponsors.
What are your future plans and goals for Szasz&Co. Bt., and how do you envision the company contributing to the advancement of healthcare and clinical research in Europe?
Szasz&Co. Bt. aims to support small and mid-sized sponsor companies in developing new therapeutic opportunities, ultimately improving the health and well-being of people. Our goal is to contribute significantly to the advancement of healthcare and clinical research across Europe.
